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

NCT07227675 | Completed FDA Device

• 1 other identifier: 11- 512
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 32

Brief 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

Keywords

Functional Mitral Regurgitation; Mitral Valve Regurgitation; Symptomatic Heart Failure; COAPT CAS

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

The MitraClip NT Device

EXPERIMENTAL

The MitraClip NT System comprises the MitraClip NT Clip Delivery System

Device: MitraClip® NT System

Interventions

MitraClip® NT System DEVICE

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

The MitraClip NT Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (32)

Scripps Green Hospital

La Jolla, California, 92037, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

El Camino Hospital

Mountain View, California, 94040, United States

Location

Stanford Hospital and Clinics

Stanford, California, 94305, United States

Location

University of Colorado Hospital

Denver, Colorado, 80045, United States

Location

Mount Sinai Medical Center

Miami, Florida, 33140, United States

Location

Tallahassee Memorial Hospital

Tallahassee, Florida, 32308, United States

Location

Piedmont Hospital Atlanta

Atlanta, Georgia, 30309, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Columbia University Medical Center / New York Presbyterian Hospital

New York, New York, 10032, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

Atrium Health Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, 73120, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States

Location

Seton Medical Center Austin

Austin, Texas, 78705, United States

Location

Baylor Heart and Vascular Hospital

Dallas, Texas, 75204, United States

Location

The heart hospital baylor plano

Plano, Texas, 75093, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23284, United States

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2025
• First Posted: November 13, 2025
• Study Start: October 23, 2017
• Primary Completion: March 14, 2019
• Study Completion: March 31, 2024
• Last Updated: November 13, 2025

Record last verified: 2025-11

Locations

US (32)