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|
| General |
| Study Status |
Progress Adequate |
Application Number /
Requirement Number |
P100009 / PAS001 |
| Date Original Protocol Accepted |
10/24/2013
|
| Date Current Protocol Accepted |
06/13/2014
|
| Study Name |
Comprehensive/Linked-Registry Based Surv
|
| Device Name |
MITRACLIP DELIVERY SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Comprehensive/Linked/RegistryBased Surveillance
|
| Data Source |
External Registry
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
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 |
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.
|
| Sample Size |
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.
|
| Key Study Endpoints |
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).
|
| Follow-up Visits and Length of Follow-up |
5 years
Discharge, 30 days, 1 year annually through 5 years
|
