In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 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.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
Objectives: to assess long term safety and effectiveness of the MitraClip device in a broad patient
population and to study how prohibitive 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.
Study Population Description
Patients who have been determined to be at prohibitive risk for mitral 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 least one 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-up from 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 year
The 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 interventions Secondary Safety/Effectiveness Endpoints: Interpretation of the definition of prohibitive risk status in commercial use will also be reported on. Prohibitive risk status will be 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).
Followup Visits and Length of Followup
5 years Discharge, 30 days, 1 year annually through 5 years
OSB Lead-Comprehensive/Linked-Registry Based Surv