Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional MR (COAPT CAS)

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

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).

Study Overview

• Status: Completed
• Conditions: Mitral Regurgitation; Mitral Valve Regurgitation
• Intervention / Treatment: Device: MitraClip® NT System

• Study Type: Interventional
• Enrollment (Actual): 162
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Scripps Green Hospital
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • Mountain View, California, United States, 94040
      • El Camino Hospital
    • Stanford, California, United States, 94305
      • Stanford Hospital and Clinics
  • Colorado
    • Denver, Colorado, United States, 80045
      • University of Colorado Hospital
  • Florida
    • Miami, Florida, United States, 33140
      • Mount Sinai Medical Center
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Memorial Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Hospital Atlanta
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Hospital of Kansas City
    • St Louis, Missouri, United States, 63110
      • Barnes Jewish Hospital
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Morristown Medical Center
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Medical Center
    • New York, New York, United States, 10032
      • Columbia University Medical Center / New York Presbyterian Hospital
    • Roslyn, New York, United States, 11576
      • St. Francis Hospital
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Atrium Health Carolinas Medical Center
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Christ Hospital
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Oklahoma Heart Hospital
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
    • Portland, Oregon, United States, 97225
      • Providence St. Vincent Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Presbyterian
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Shadyside Hospital
  • Texas
    • Austin, Texas, United States, 78705
      • Seton Medical Center Austin
    • Dallas, Texas, United States, 75204
      • Baylor Heart and Vascular Hospital
    • Plano, Texas, United States, 75093
      • The Heart Hospital Baylor Plano
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center
  • Virginia
    • Richmond, Virginia, United States, 23284
      • Virginia Commonwealth University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subjects who have national Medicare coverage by CMS
• Symptomatic functional MR (≥3+) due to cardiomyopathy of either ischemic or non-ischemic etiology
• Subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, mitral regurgitation and heart failure
• Subject has had at least one hospitalization for heart failure in the 12 months prior to subject registration and/or a corrected BNP ≥300 pg/ml or corrected NT-proBNP ≥1500 pg/ml
• New York Heart Association (NYHA) Functional Class II, III or ambulatory IV
• Surgery will not be offered as a treatment option and medical therapy is the intended therapy for the subject
• Left Ventricular Ejection Fraction (LVEF) is ≥20% and ≤50%
• Left Ventricular End Systolic Dimension (LVESD) is ≤70 mm

Exclusion Criteria:

• Untreated clinically significant coronary artery disease requiring revascularization
• Coronary artery bypass grafting (CABG) within prior 30 days
• Percutaneous coronary intervention within prior 30 days
• Tricuspid valve disease requiring surgery
• Aortic valve disease requiring surgery
• Chronic Obstructive Pulmonary Disease (COPD) requiring continuous home oxygen therapy or chronic outpatient oral steroid use
• Cerebrovascular accident within prior 30 days
• Severe symptomatic carotid stenosis (> 70% by ultrasound)
• Carotid surgery within prior 30 days
• Mitral valve orifice area < 4.0 cm2
• Leaflet anatomy which may preclude MitraClip implantation, proper MitraClip positioning on the leaflets or sufficient reduction in MR by the MitraClip

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The MitraClip NT Device; The MitraClip NT System comprises the MitraClip NT Clip Delivery System	Device: MitraClip® NT System; The MitraClip NT System is intended to treat heart failure patients with symptomatic ischemic or non-ischemic functional MR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety end point: Freedom from death	through 5 years
Safety end point: Freedom from Myocardial Infarction (MI)	through 5 years
Safety end point: Freedom from stroke	through 5 years
Safety end point: Heart Failure Hospitalization	through 5 years
Recurrent Heart Failure Hospitalization	through 5 years

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Michael Mack, MD, Baylor Health Care System; Principal Investigator: William T Abraham, MD, The Ohio State University Heart Center; Principal Investigator: JoAnn Lindenfeld, MD, Vanderbilt University Medical Center; Principal Investigator: Gregg W Stone,, MD, Mount Sinai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2017
• Primary Completion (Actual): March 14, 2019
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: November 11, 2025
• First Submitted That Met QC Criteria: November 11, 2025
• First Posted (Estimated): November 13, 2025

Study Record Updates

• Last Update Posted (Estimated): November 13, 2025
• Last Update Submitted That Met QC Criteria: November 11, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Mitral Valve Regurgitation; Functional Mitral Regurgitation; Symptomatic Heart Failure; COAPT CAS
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: 11- 512

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes