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Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional MR

NCT07227675 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2025-11-13

No results posted yet for this study

Summary

The COAPT Continued Access Study (CAS) is an extension of the COAPT RCT under the same IDE (G120024). COAPT CAS was a single-arm, prospective, multicenter continued access registry that enrolled heart failure patients with secondary mitral regurgitation who remained symptomatic despite optimal guideline-directed medical therapy (GDMT). The objective of the COAPT CAS is to continue the evaluation of safety and effectiveness of the MitraClip NT System under more "real world" conditions in patients who meet the COAPT inclusion/exclusion criteria and who have national Medicare coverage by the Centers for Medicare and Medicaid Services (CMS).

Conditions

  • Mitral Regurgitation
  • Mitral Valve Regurgitation

Interventions

DEVICE

MitraClip® NT System

The MitraClip NT System is intended to treat heart failure patients with symptomatic ischemic or non-ischemic functional MR

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Michael Mack, MD · Baylor Health Care System

  • William T Abraham, MD · The Ohio State University Heart Center

  • JoAnn Lindenfeld, MD · Vanderbilt University Medical Center

  • Gregg W Stone,, MD · MOUNT SINAI HOSPITAL

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-23
Primary Completion
2019-03-14
Completion
2024-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07227675 on ClinicalTrials.gov