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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P100009 S028/ PAS002 |
| Date Original Protocol Accepted |
07/26/2019
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| Date Current Protocol Accepted |
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| Study Name |
Registry-Based CAP Cohort and RWU Surveillances
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| Device Name |
MitraClip NT Clip Delivery System and MitraClip NTR/XTR Clip Delivery System
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| General Study Protocol Parameters |
| Study Design |
Comprehensive/Linked/RegistryBased Surveillance
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| Data Source |
External Registry
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| Comparison Group |
Historical Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
Comprehensive/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.
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| Study Population |
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.
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| Sample Size |
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.
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| Key Study Endpoints |
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.
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| Follow-up Visits and Length of Follow-up |
5 years
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| Interim or Final Data Summary |
| Interim Results |
COAPT CAS Cohort:
At 1-year follow up, Kaplan Meier estimated events were 24.1% death, 0.6% stroke, and 25.4% % heart failure hospitalizations. Based on reported events, 2.5% (4 of 162 subjects) experienced mitral valve reintervention.
At 4-year follow up, Kaplan Meier estimated events were 57.3% death, 2.6% stroke, and 63.2% % heart failure hospitalizations. Based on reported events, <10% (less than 11 of 107 subjects, due to CMS data (cell size) policy) experienced mitral valve reintervention.
RWU Surveillance Cohort:
At 1-year follow up, Kaplan Meier estimated events were 22.0% death, 2.4% stroke, 19.0% heart failure hospitalizations, and 3.5% need for repeat procedure for mitral valve-related dysfunction.
At. 3-year follow up, Kaplan Meier estimated events were 49.2% death, 7.7% stroke, 80.3% all-cause hospitalizations, and 7.5% need for repeat procedure for mitral valve-related dysfunction. Based on reported events, 840 patients had heart failure hospitalizations
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| Actual Number of Patients Enrolled |
COAPT Continued Access Study (CAS) Cohort = 162;
Real World Use (RWU) Surveillance Cohort = 5000
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| Actual Number of Sites Enrolled |
COAPT CAS Cohort = 32 sites;
RWU Surveillance Cohort = 406 hospitals
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| Patient Follow-up Rate |
COAPT CAS Cohort: 89% at 1 year (excluding deaths), with 5 withdraws, 2 lost-to-follow up- and 6 missed visits.
RWU Surveillance Cohort: 66% at 1 year (excluding 921 deaths), with 12 withdraws, 302 lost-to-follow up, and 1064 missed visits
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