FDA Post Approval Studies Database

$179 / year

The Post-Approval Studies (PAS) Database identifies the reporting status of PAS studies based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH’s effort to ensure that all PAS commitments are fulfilled in a timely manner.

Complexity

CDRH’s Post-Approval Studies Program ensures that methodologies are well-designed and conducted effectively, efficiently and in the least burdensome manner. In 2005, the Division of Epidemiology (DEPI) in CDRH’s Office of Surveillance and Biometrics (OSB) assumed responsibility for overseeing the program. Along with OSB, other CDRH offices including the Office of Device Evaluation (ODE), and the Office of In-Vitro Diagnostics and Radiological Health (OIR), share PAS Program responsibilities for design, tracking, oversight, and review of these mandated studies. Post-approval studies (PAS) are conditions of device approval. A sponsor’s failure to comply with any post-approval requirement may be grounds for withdrawing approval.

CDRH has established the Post-Approval Studies Database to share general information regarding each PAS ordered since January 1, 2005, provides the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant’s current reporting status for each submission due. The database refreshes every Sunday with any new or revised information on study protocol parameters (e.g., patient population), overall study status, or information related to the review of data from interim or final reports.

Date Created

2005

Last Modified

2020-04-20

Version

2020-04-20

Update Frequency

Irregular

Temporal Coverage

1991-09 to 2020-04

Spatial Coverage

United States

Source

John Snow Labs; Food and Drug Administration (FDA);

Source License URL

Source License Requirements

N/A

Source Citation

N/A

Keywords

CDRH and Applicants, CDRH’s Post-Approval Studies, Post-Approval Studies, PAS, Post-Approval Device

Other Titles

Post-Approval Studies, Medical Device Post-Approval Studies

NameDescriptionTypeConstraints
Application_NumberPAS Application Numberstringrequired : 1
Applicant_NameThe Applicant Namestringrequired : 1
Device_NameMedical Device Namestringrequired : 1
Medical_SpecialtyMedical Specialty of the Medical Devicestringrequired : 1
Date_PMA_ApprovedPremarket-Approval (PMA) Approved Datedaterequired : 1
Study_NameMedical Device Study Namestringrequired : 1
Protocol_Accepted_DateThe Protocol Accepted Datedate-
Current_Protocol_Accepted_DateThe Current Protocol Accepted Datedate-
Study_StatusThe status of the study determined by the FDA After the review of a supplement with a protocol or of an interim or final report.string-
Study_Progress_ReasonMedical device study progress reasonstring-
Study_DesignMedical device study designstring-
Is_Study_Involve_Follow_Up_Of_Premarket_CohortStudy involve follow-up of premarket cohortboolean-
Data_SourceThe Data sourcestringenum : Array
Comparison_GroupMedical device comparison groupstring-
Analysis_TypeMedical device analysis typestringenum : Array maxLength : 11
Study_PopulationMedical device study populationstring-
Study_Design_DescriptionMedical device study design descriptionstring-
Study_Population_DescriptionMedical device study population descriptionstring-
Sample_SizeStudy sample sizestring-
Data_CollectionData collectionstring-
Followup_Visits_and_Length_of_FollowupFollowup Visits and Length of Followupstring-
Actual_Number_of_Patients_EnrolledActual Number of Patients Enrolledstring-
Actual_Number_of_Sites_EnrolledActual Number of Sites Enrolledstring-
Patient_Followup_RatePatient Followup Ratestring-
Final_Safety_FindingsFinal medical device safety findingsstring-
Final_Effectiveness_FindingsFinal effectiveness findingsstring-
Study_Strengths_and_WeaknessesMedical device study strengths and weaknessesstring-
Recommendations_for_Labeling_ChangesRecommendations for medical device labeling changesstring-
Interim_Safety_InformationSafety information of the interimstring-
Application NumberApplicant NameDevice NameMedical SpecialtyDate PMA ApprovedStudy NameProtocol Accepted DateCurrent Protocol Accepted DateStudy StatusStudy Progress ReasonStudy DesignIs Study Involve Follow Up Of Premarket CohortData SourceComparison GroupAnalysis TypeStudy PopulationStudy Design DescriptionStudy Population DescriptionSample SizeData CollectionFollowup Visits and Length of FollowupActual Number of Patients EnrolledActual Number of Sites EnrolledPatient Followup RateFinal Safety FindingsFinal Effectiveness FindingsStudy Strengths and WeaknessesRecommendations for Labeling ChangesInterim Safety Information
P170038 / PAS001AbbottCentriMag Circulatory Support SystemCardiovascular2019-12-06CentriMag FTW PASProtocol Pending
P160030 / PAS001ABBOTT DIABETES CARE INC.Freestyle Libre Flash Glucose Monitoring SystemClinical Chemistry2017-09-27FreeStyle Libre Flash Glucose Monitoring2017-12-082018-09-25Progress AdequateProspective Cohort StudyFalseNew Data CollectionDevice Subjects Serve as Own ControlAnalyticalTransit. Adolescent B (as adults) : 18-21 yrs; Adult: >21This is a one-year prospective; multi-center; nonrandomized; single-arm; post-approval study of the FreeStyle Libre 14 Day Flash CGM intended to characterize the safety of the device when used in people with type 1 and type 2 diabetes non-adjunctively in ages 18 years and up.Subjects will utilize capillary SMBG for managing diabetes for 6 months (control phase) followed by diabetes management using the FreeStyle Libre 14 Day Flash for 6 months (intervention phase). Subjects will maintain a diary/log book of adverse events during each phase. Assessment ofadverse events will occur via self-reporting at each monthly visit and/or phone call. Subjects will also complete a Quality of Life questionnaire at the completion of the control phase and the intervention phase. Up to 920 subjects will be enrolled in up to 10 sites to obtain at least 736subjects who complete the study. The purpose of this study is to characterize the safety of the Libre 14 Day Flash Glucose Monitoring System when used in the intended use population.Adult (18 years of age and up) with type 1 and type 2 diabetes that meet the inclusion/exclusion criteria will be studied.The device is investigational in ages 4-17 years. The 4-17 year age group will also be studied under an approved IDE G170269/S001.Inclusion Criteria:Subjects will be considered for enrollment in the study if they meet all of the following criteria:1. Subject must be at least 18 years of age2. Subject must have a diagnosis of type 1 or type 2 diabetes mellitus3. Subject is currently using SMBG for managing their diabetes4. Subject must be able to read and understand English and/or Spanish5. In the investigators opinion; the subject must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol6. Subject must have access to an internet connected for uploading data from the blood glucose meter and FreeStyle Libre system.7. Subject must be willing and able to provide written signed and dated informed consent and assent when appropriate.Exclusion Criteria:1. Subject is a member of the Site Staff2. Subject is currently using or has previously used a continuous glucose monitoring system for managing their diabetes3. Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.4. Subject is pregnant at the time of enrollment5. Subject is on dialysis at the time of enrollment6. Subject has concomitant medical condition which; in the opinion of the investigator; could interfere with the study or present a risk to thesafety or welfare of the subject or study staff7. Subject currently participating in another clinical trial8. Subject is unsuitable for participation due to any other cause as determined by the investigator.Up to 920 subjects will be enrolledPrimary Endpoint:An analysis of the rate of severe hypoglycemic andhyperglycemic events will compare the intervention phase(approximate days 180 to 365) to the controlphase(approximate days 1-180).Secondary Endpoints:BG frequency in the control and intervention phasesScan frequency in the intervention phaseChange in HbA1cDTSQ (Quality of Life Questionnaire).Follow-up visits are scheduled throughout the study period for 12 months.
P150004 / PAS001Abbott MedicalAxium Neurostimulator SystemNeurology2016-02-11F/U Axium Neurostimulator System (FANS)2016-05-262017-07-26Progress AdequateProspective Cohort StudyFalseNew Data CollectionObjective Performance CriterionAnalyticalAdult: >21The FANS PAS is a prospective; multicenter; single arm; observational post-approval study to be conducted at up to 45 centers in the United States in order to demonstrate continued safety and effectiveness of the Axium Neurostimulator System or the Proclaim DRG Neurostimulator System. The primary objective of the FANS PAS is to demonstrate that the proportion of serious adverse events (SAEs) at 12 months for subjects who receive a permanent implant is lower than a pre-specified performance goal. Secondary objectives of the FANS PAS are to evaluate change in overall pain intensity; change in physical function and change in quality of life over the study period.A maximum of 426 adult subjects with moderate to severe chronic; intractable pain of the lower limbs due to CRPS types I and II will undergo a trial of the neurostimulator system at up to 45 study sites in the United States.Inclusion Criteria: Male or female between the ages of 22 and 75 years. Moderate to severe chronic intractable pain of the lower limbs resulting from Complex Regional Pain Syndrome (CRPS) types I or II. Baseline VAS score of > 60 mm for overall pain at the time of the baseline assessment. Willing and able to comply with the study requirements. Able to provide written informed consent.Exclusion criteria: Subject has an active implantable medical device including but not limited to cardiac pacemakers and cardiac defibrillators. Subject is currently involved in medically-related litigation; including workers compensation. Subject has a life expectancy of less than one year. Subject is pregnant or of child bearing potential and not using adequate contraception as determined by the investigator. Subject has; or plans to have; a spinal cord stimulation system or infusion pump system implanted. Subject has; or plans to have; a peripheral nerve stimulation system (PNS) or peripheral nerve field stimulation system (PNfS) implanted. Subject is considered a poor surgical or study candidate; which may include; but is not limited to the following: any medical; social; or psychological problem that could complicate the implant procedure and/or recovery from the implant procedure or could complicate the required procedures and evaluations of the study in the judgment of the investigator.The sample size required to reject the null hypothesis for the primary endpoint at the 5% significance level with 80% power assuming a 12-month SAE rate of 10.5% is 287 subjects receiving the permanent Axium or Proclaim DRG IPG. Assuming an attrition rate of 25% from trial to permanent Axium or Proclaim DRG IPG implant; and an attrition rate of 10% from permanent implant to 12-month follow-up; a total of 426 (=287/0.9/0.75)subjects will be implanted with a trial system. The target number of subjects for permanent Axium or Proclaim DRG IPG implants is 319; and the target number of subjects for the primary endpoint analysis is 287.Primary EndpointThe primary endpoint is the 12-month SAE rate for subjects receiving the permanent DRG IPG.Secondary Endpoints Percent change from baseline to 12 months post-permanent implant for overall pain intensity measured using the Visual Analog Scale (VAS)Change from baseline to 12 months post-permanent implant for physical function measured using the PROMIS-29 Profile Change from baseline to 12 months post-permanent implant for quality of life measured using the PROMIS Global Health ScaleDescriptive EndpointsSafety Proportion of subjects with device; procedure or stimulation related SAEs and non-SAEs among subjects who receive the permanent implant Proportion of subjects who have AEs related to the trial implant procedure among subjects who fail the trial neurostimulator phase Summary of procedure-related SAEs and non-SAEs by implanter experienceEffectiveness Change from baseline to 1; 3; and 6 months post permanent implant for overall pain intensity measured using the Visual Analog Scale (VAS) Change from baseline to 1; 3; and 6 months post permanent implant for physical function measured using the PROMIS-29 Profile Change from baseline to 1; 3; and 6 months post-permanent implant for quality of life measured using the PROMIS Global Health Scale Change from baseline to 1; 3; 6 and 12 months post-permanent implant for neuropathic pain measured using the Neuropathic Pain Scale (NPS) Change from baseline to 1; 3; 6 and 12 months post-permanent implant for sleep disturbance; anxiety; depression; fatigue; ability to participate in social roles and activities; paininterference and pain intensity measured using the PROMIS-29 Profile Patient Global Impression of Change (PGIC) at 1; 3; 6 and 12 months post-permanent implantAdditional DataAll descriptive endpoints above will be examined at 18 and 24 months for all subjects with evaluable data for those study visits. Additional data; including but not limited to; percentage of subjects achieving at least a 30% and 50% pain reduction; demographics; paresthesia coverage and intensity; subject satisfaction; programming parameters; implant procedure information; and system information may be compiled.up to 24 months
P040040 / PAS002Abbott MedicalAMPLATZER MUSCULAR VSD OCCLUDERCardiovascular2007-09-07Post Approval Study2007-09-072016-03-18Progress InadequateSubject enrollment milestones not metProspective & Retrospective StudyFalseNew Data CollectionHistorical ControlAnalyticalInfant: 29 days-2 yrs; Child: 2-12 yrs; Adolescent: 13-18 yrs; Transit. Adolescent A (distinctively) : 18-21 yrs; Transit. Adolescent B (as adults) : 18-21 yrs; Adult: >21; All Pediatric Patients: 0-21 yrsThis study is a prospective; non-randomized; multi-site clinical study. The primary safety objective is to evaluate the proportion of subjects experiencing a major (serious) adverse event within 12 months of the procedure. The effectiveness objective is to evaluate the proportion of subjects whom experience technical success; closure success; and acute procedure success.This device is indicated for use in patients with a complex VSD of significant size to warrant closure (large volume left to right shunt; pulmonary hypertension and or clinical symptoms of congestive heart failure) who are considered to be at high risk for standard transatrial or transarterial surgical closure based on anatomical conditions and or based on overall medical condition. Eligible patients can be enrolled retrospectively.The comparison group is the Historical Control.One hundred (100) subjects will be enrolled at up to 50 U.S. sites and additional sites in Europe and Canada.If subject follow-up drops below 80%; additional subjects will be enrolled to ensure a final population of 80 subjects either meet a defined endpoint or are followed for five years.Primary safety endpoint:Any major (serious) adverse event within 12 months of the procedure. A serious adverse event is defined as any untoward medical occurrence that: results in death; is a life-threatening adverse event; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or is a medically significant event.Primary effectiveness endpoints: Technical Success Acute Procedure Success Shunt Closure Success at 12 monthsEach study subject receiving a device will be followed for 60 months post-procedure; unless the device is explanted. Follow-up assessments will be conducted at 30 days; 6 months ; one year; and annually until the five-year visit is complete. If the delivery system enters the subject’s body in an attempt to place a device but no device is implanted during the initial procedure; the subject will be discontinued from the study after a 30-day adverse event collection period.If the device explant occurs before the 12-month visit and a SAE is associated with the device explant; the subject will be discontinued on the date the device is explanted. (In this case; the subject is considered a failure for all endpoints except Technical Success.)If a device explant is not associated with a SAE; the subject will continue to be followed through the 12-month visit. The subject will then be discontinued at the 12-month visit. If a subject has a device explanted after the 12-month visit; the subject will be discontinued on the date of the explant procedure.
P040040 / PAS001Abbott MedicalAMPLATZER MUSCULAR VSD OCCLUDERCardiovascular2007-09-075 year long term (IDE)2007-09-072007-09-07TerminatedOther reasonProspective Cohort StudyTrueSponsor RegistryConcurrent ControlDescriptiveChild: 2-12 yrs; Adolescent: 13-18 yrs; Transit. Adolescent B (as adults) : 18-21 yrs; Adult: >21This study will provide long-term follow-up of forty-three subjects from the premarket cohort that have been designated as High Risk.This device is indicated for use in patients with a complex VSD of significant size to warrant closure (large volume left to right shunt; pulmonary hypertension and/or clinical symptoms of congestive heart failure) who are considered to be at high risk for standard transatrial or transarterial surgical closure based on anatomical conditions and/or based on overall medical condition.43 patients; 21 sitesSafety endpoints include adverse events.Annual office visits were required out to 5 years.43.038.00.0A total of 35 overall events were reported in 20 of 43 subjects (46.5%). The most frequently reported event was hypotension which was reported in 11.6% of subjects (5 reports in 5 of 43 subjects).Strengths: Lessons learned on requesting for long term follow-up consent at tiem of IDE enrollmentWeaknesses: Extremely low follow-up of the cohort.No labeling changes were recommended.The study was terminated early due a low follow-up rate
H070005 / PAS001Abbott MedicalTHE AMPLATZER POST INFARCT MUSCULAR VSD OCCLUDERCardiovascular2017-01-10AMPLATZER PIVSD Occluder PAS2017-04-132019-01-24Progress AdequateRetrospective Cohort StudyFalseNew Data CollectionNo ControlDescriptiveTransit. Adolescent A (distinctively) : 18-21 yrs; Transit. Adolescent B (as adults) : 18-21 yrs; Adult: >21To evaluate the safety and probable benefit of the AMPLATZER PIVSD Occluder in patients undergoing implantation of the PIVSD Occluder following an acutemyocardialinfarction. This is multicenter; retrospective non-randomized; observational study.The intended population for the AMPLATZER™ PIVSD Occluder are patients with post-myocardial infarct muscular ventricular septal defect (VSD) who are not satisfactory surgical candidates. The study will enroll subjects in two cohorts:First Cohort: All available Emergency and Compassionate PIVSDOccluder subject data from 2011 to end of 2016.All subjects belonging to this cohort must have undergone an attempt to close a post-infarct VSD using the AMPLATZER™ PIVSD Occluder.Second Cohort: The second cohort will be comprised of subjects over the age of 18 who are successfully implanted with a PIVSD Occluder from 2011 onwards. The index procedure must have occurred >6 months prior to enrollment.The subjects must meet following conditions:Subject or subject’s legally authorized representative hasprovided consent to participate in this study.Subject’s post-procedure echocardiogram is evaluable and can be sent to the echocardiography core laboratory for residual shunt assessment.First Cohort: All available Emergency and Compassionate PIVSD Occluder subject data from 2011 to the end of 2016.Second Cohort: A total of 30 subjects who have been successfully implanted with PIVSD occluder and have data for the residual shunt assessed by the echocardiography core laboratory post procedure will be enrolled from up to 50 centers in the US.Cohort 1:Acute Survival: is defined as survival for at least 24 hours following an attempted PIVSD device implant.Chronic Survival: is defined as survival for at least 183 days post-procedure.Technical Success: Technical success occurs when a subject is successfully implanted with a PIVSD device in the ventricular septal defect. An implant attempt occurs when the delivery system is inserted in the subject’s vasculature.Cohort 2:Acute Closure: defined as the absence of a residual shunt greater than or equal to 3 mm; and will be assessed based on an echocardiogram obtained immediately after successful deployment of the device and up to 7 days post-procedure.Chronic Closure: defined as the absence of a residual shuntgreater than or equal to 3 mm at 6 months or later (where 6 months is defined as greater than or equal to 150 days)Chronic Survival: is defined as survival for at least 183 days post-procedure.6 months
P020024 S052 / PAS001Abbott MedicalAMPLATZER Piccolo OccluderCardiovascular2019-01-11Continued FU of IDE/CAP cohort2019-01-11Progress AdequateProspective Cohort StudyTrueNew Data CollectionNo ControlDescriptiveNeonate: 1-28 days; Infant: 29 days-2 yrs; Child: 2-12 yrs
P100009 S028 / PAS001ABBOTT VASCULAR INC.MitraClip NT Clip Delivery System and MitraClip NTR/XTR Clip Delivery SystemCardiovascular2019-03-14Cont f/u of the COAPT Trival Pivotal CohortProgress AdequateProspective Cohort StudyTrueNew Data CollectionConcurrent ControlDescriptiveAdult: >21Continued follow-up of all living subjects who were enrolled in the COAPT Trial pivotal cohort. The objective of this PAS is to characterize the clinical outcomes annually through 5 years post-procedure.All living subjects who were enrolled in the IDE pivotal cohort.All living subjectsThe key safety and effectiveness endpoints include all-cause mortality; stroke; single leaflet device attachment; device embolization; endocarditis requiring surgery; Echocardiography Core Laboratory confirmed mitral stenosis requiring surgery; heart failure (HF) related hospitalization; New York Heart Association (NYHA) classification; 6-Minute Walk Distance (6MWD) through 2 years; Kansas City Cardiomyopathy Questionnaire (KCCQ) score through 2 years; 36-Item Short Form Survey (SF-36) score through 2 years; mitral valve surgery (including type of surgery); new use of Cardiac Resynchronization Therapy (CRT); new use of single or dual chamber pacemaker; permanent left ventricular assist device (LVAD) implant; heart transplant; additional MitraClip device intervention or de novo MitraClip device intervention; including reason for intervention; number of hospitalizations and reason for hospitalization (i.e.; heart failure; cardiovascular; non-cardiovascular) through 2 years; number of days alive and out of hospital; number of days hospitalized; proportion of subjects living in the baseline location; new onset of permanent atrial fibrillation; mitral stenosis; clinically significant atrial septal defect (ASD) that requires intervention; and dosages of guideline directed medical therapy (GDMT).5 years
P100009 S028 / PAS002ABBOTT VASCULAR INC.MitraClip NT Clip Delivery System and MitraClip NTR/XTR Clip Delivery SystemCardiovascular2019-03-14Registry-Based CAP Cohort and RWU Surveillances2019-07-26Progress AdequateComprehensive/Linked/RegistryBased SurveillanceFalseExternal RegistryHistorical ControlDescriptiveAdult: >21Comprehensive/linked/registry-based surveillances. The objectives of the surveillances are to characterize the clinical outcomes of the continued access protocol (CAP) cohort annually through 5 years post-procedure and to assess the real-world use of the commercial MitraClip System to ensure that the device is used in appropriate circumstances.Patients with symptomatic; moderate-to-severe or severe secondary (or functional) mitral regurgitation (MR; MR greater than or equal to Grade III per American Society of Echocardiography criteria) in patients with a left ventricular ejection fraction (LVEF) greater than or equal to 20% and less than or equal to 50%; and a left ventricular end systolic dimension (LVESD) less than or equal to 70 mm whose symptoms and MR severity persist despite maximally tolerated GDMT as determined by a multidisciplinary heart team experienced in the evaluation and treatment of heart failure and mitral valve disease.All living CAP subjects who were enrolled at participating institutions and a total of 5000 consecutively treated patients at a minimum of 100 representative institutions across the United States.The clinical data through one (1) year will be collected through the TVT Registry. The follow-up data (including all-cause mortality; stroke; repeat procedure for mitral valve-related dysfunction; and hospitalization) from year 2 through year 5 post procedure will be obtained through linking the TVT data with the Centers for Medicare and Medicaid Services (CMS) claims database.5 years
P100009 / PAS001ABBOTT VASCULAR INC.MITRACLIP DELIVERY SYSTEMCardiovascular2013-10-24Comprehensive/Linked-Registry Based Surv2013-10-242014-06-13Progress AdequateComprehensive/Linked/RegistryBased SurveillanceFalseExternal RegistryConcurrent ControlDescriptiveAdult: >21Objectives: to assess long term safety and effectiveness of theMitraClip device in a broad patient population and to study howprohibitive risk is interpreted in real-world use of the MitraClip device to ensure the device is used in appropriate circumstances.Study design: a prospective; single-arm; multi-center; observational study of a minimum of 2;000 MitraClip patients consecutively entered into the TVT Registry. A new enrollment study.Patients who have been determined to be at prohibitive risk formitral valve surgery by a heart team; and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation; patients treated in accordance with the MitraClip Clip Delivery System labeling; formal protocol- specific inclusion and exclusion criteria will not be used.Cohort A: Patients treated per the MitraClip Clip Delivery System indication approved on October 24; 2013 will comprise Cohort A. Patients will be identified as Cohort A for analyses if the data collected on the eCRFs identify symptomatic DMR ≥3+ and at leastone reason for prohibitive risk.Cohort B: patients from the PAS 1 Device Registry who are not included in Cohort A.Subjects: 2;000 MitraClip patients consecutively entered into the TVT Registry.Sites: This study will include all sites participating in the STS/ACCF TVT Registry and trained by Abbott Vascular to implant the MitraClip device.A minimum of 2;000 patients will allow detection of low frequency safety events and provide improved precision for the rates of safety events that have previously been characterized.Primary Safety/Effectiveness Endpoints:The following endpoints will be reported through 1 year follow-upfrom data extracted from the TVT-R:¿ All-cause mortality at 30 days and 1 year¿ Stroke at 30 days and 1 year¿ NYHA Functional Class at 30 days and 1 year¿ Hospitalizations (All-cause and HF-related) at 1 year¿ The echo parameters of MR severity; left ventricular end-diastolic volume (LVEDV) and Left Ventricular Internal Dimension-Diastole (LVIDd) at baseline; 30 days and 1 year in all patients and in the subset of patients who undergo mitral valve (MV) surgery within the first yearThe following endpoints will be reported for years 2 - 5 post-implant by linking data extracted from the TVT Registry to the Center for Medicare and Medicaid Services (CMS) Claims database:¿ All-cause mortality¿ Stroke¿ Hospitalizations (All-cause and HF-related)¿ Surgical interventionsSecondary Safety/Effectiveness Endpoints:Interpretation of the definition of prohibitive risk status incommercial use will also be reported on. Prohibitive risk status willbe audited by a qualified MitraClip Registry Audit Committee Charter (MRAC) that meets quarterly. The composition and the schedule for auditing is described in the MRAC Charter document (received on June 10; 2014).5 yearsDischarge; 30 days; 1 year annually through 5 years