Mitral RegurgitationCOAPT CASNCT07227675
Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional MR
A study testing MitraClip® NT System in people with Mitral Regurgitation and Mitral Valve Regurgitation, run by Abbott Medical Devices at 32 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation, Mitral Valve Regurgitation
- What is being tested?
- MitraClip® NT System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 32 sitesUnited States
- Study dates
- 23 Oct 2017to 31 Mar 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Piedmont Hospital Atlanta
Atlanta, Georgia, 30309
Seton Medical Center Austin
Austin, Texas, 78705
University of Maryland Medical Center
Baltimore, Maryland, 21201
Massachusetts General Hospital
Boston, Massachusetts, 02114
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, 28203
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
The Christ Hospital
Cincinnati, Ohio, 45219
Cleveland Clinic
Cleveland, Ohio, 44195
Baylor Heart and Vascular Hospital
Dallas, Texas, 75204
University of Colorado Hospital
Denver, Colorado, 80045
Duke University Medical Center
Durham, North Carolina, 27710
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Scripps Green Hospital
La Jolla, California, 92037
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Mount Sinai Medical Center
Miami, Florida, 33140
Morristown Medical Center
Morristown, New Jersey, 07960
El Camino Hospital
Mountain View, California, 94040
Intermountain Medical Center
Murray, Utah, 84107
NYU Langone Medical Center
New York, New York, 10016
Columbia University Medical Center / New York Presbyterian Hospital
New York, New York, 10032
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
The heart hospital baylor plano
Plano, Texas, 75093
Providence St. Vincent Medical Center
Portland, Oregon, 97225
Oregon Health and Science University
Portland, Oregon, 97239
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23284
St. Francis Hospital
Roslyn, New York, 11576
Barnes Jewish Hospital
St Louis, Missouri, 63110
Stanford Hospital and Clinics
Stanford, California, 94305
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308
About this study
Official title: 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).
- Conditions
- Mitral Regurgitation, Mitral Valve Regurgitation
- Being tested
- MitraClip® NT System
- Keywords
- Functional Mitral Regurgitation, Mitral Valve Regurgitation, Symptomatic Heart Failure, COAPT CAS
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitraClip® NT SystemDevice
The MitraClip NT System is intended to treat heart failure patients with symptomatic ischemic or non-ischemic functional MR
| Study group | Role | What they receive |
|---|---|---|
| The MitraClip NT Device | Experimental | The MitraClip NT System comprises the MitraClip NT Clip Delivery System Receives: Device: MitraClip® NT System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety end point: Freedom from death
Measured: through 5 years
Safety end point: Freedom from Myocardial Infarction (MI)
Measured: through 5 years
Safety end point: Freedom from stroke
Measured: through 5 years
Safety end point: Heart Failure Hospitalization
Measured: through 5 years
Recurrent Heart Failure Hospitalization
Measured: through 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2025
- Study start23 Oct 2017
- Primary completion14 Mar 2019
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Mack, MD, Principal investigator, Baylor Health Care SystemWilliam T Abraham, MD, Principal investigator, The Ohio State University Heart CenterJoAnn Lindenfeld, MD, Principal investigator, Vanderbilt University Medical CenterGregg W Stone,, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07227675
- Sponsor's protocol ID
- 11- 512
- Acronym
- COAPT CAS
- Status last verified
- Nov 2025
- First submitted
- 11 Nov 2025
- Last updated
- 13 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes