# COAPT trial

Study · id `cardio:coapt` · Cardiovascular Atlas · release `f6f6f1b6f50379ed` (public)

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Also called: COAPT; Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation

Browse, organ or system: Heart  
Browse, condition area: Heart failure; Valve and congenital heart disease  

## In plain language

A trial in 614 people with heart failure and a leaking mitral valve caused by the weak heart muscle, who still had symptoms on maximal medicines. Adding the MitraClip device to medicines led to fewer hospital stays for heart failure and fewer deaths within two years than medicines alone. It was paid for by Abbott, the applicant for the device's US approval, and the registry lists no masking.

## Technical summary

Registry NCT01626079 (Abbott Medical Devices lead sponsor, class industry, status unknown, estimated completion 2024-07 which is out of date). Randomized, parallel, no masking, treatment. The registry count (776) includes a continued access study (COAPT CAS, 162 patients); the paper reports 614 enrolled. Abstract: annualized heart-failure hospitalizations 35.8% versus 67.9% per patient-year (hazard ratio 0.53); death within 24 months 29.1% versus 46.1% (hazard ratio 0.62). Findings tabulated: death only, because the hospitalization end point has no outcome record in this atlas.

## Key facts

- Design: Randomized, parallel-group, open-label trial of transcatheter mitral-valve repair plus medical therapy versus medical therapy alone. The registry records allocation as randomized, intervention model as parallel and masking as none, and adds a continued access group.
- Phase: Not applicable
- Enrolled: 776 participants (enrolled count; Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS, snapshot `cardio:ctgov-nct01626079-2026-10-14`, retrieved 2026-10-14); 614 patients (enrolled count; Transcatheter Mitral-Valve Repair in Patients with Heart Failure, snapshot `cardio:pubmed-30280640-2026-10-14`, retrieved 2026-10-14)
- Started: 2012-08 (actual) (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS, snapshot `cardio:ctgov-nct01626079-2026-10-14`, retrieved 2026-10-14)
- Primary completion: 2019-03 (actual) (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS, snapshot `cardio:ctgov-nct01626079-2026-10-14`, retrieved 2026-10-14)
- Completion: 2024-07 (anticipated) (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS, snapshot `cardio:ctgov-nct01626079-2026-10-14`, retrieved 2026-10-14)
- Results first posted: 2020-05-06 (actual) (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS, snapshot `cardio:ctgov-nct01626079-2026-10-14`, retrieved 2026-10-14)
- Countries: United States; Canada (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS, snapshot `cardio:ctgov-nct01626079-2026-10-14`, retrieved 2026-10-14)
- Care setting: 78 sites in the United States and Canada (abstract). (Transcatheter Mitral-Valve Repair in Patients with Heart Failure, snapshot `cardio:pubmed-30280640-2026-10-14`, retrieved 2026-10-14)
- Registry status: "UNKNOWN" (U.S. National Library of Medicine (ClinicalTrials.gov), snapshot `cardio:ctgov-nct01626079-2026-10-14`, retrieved 2026-10-14)

## Study findings

Findings are grouped by the claim they support. Each group keeps its own population and follow-up, and each finding keeps its own denominator and time window. Not reported is not zero.

### In COAPT, death from any cause within 24 months occurred in 29.1% of the patients in the MitraClip plus medicines group and in 46.1% of the patients in the medicines alone group (hazard ratio 0.62, 95% confidence interval 0.46 to 0.82).

Claim `cardio:claim-coapt-all-cause-death`.

Applies to: Recipient: Adult; Population: Patients 18 years or older (registry minimum age) with heart failure and moderate-to-severe or severe secondary mitral regurgitation who remained symptomatic despite maximal doses of guideline-directed medical therapy; 614 were randomized (302 to the device group and 312 to the control group). The registry record also covers a continued access study of 162 further patients. The detailed inclusion and exclusion criteria are in the registry record and were not extracted.; Care setting: 78 sites in the United States and Canada (abstract); Geography: United States and Canada; Life stage: Registry minimum age 18 years; no maximum age; Follow-up: The primary effectiveness end point covers 24 months; the primary safety end point is at 12 months (abstract). The registry gives the primary completion as 2019-03 and an estimated study completion of 2024-07, with a recruitment status of unknown.

Limitations: The abstract does not name death from any cause among the end points in its methods; it reports 24-month death as a result. The registry lists all-cause mortality among its secondary outcomes (a count at 12 months, and Kaplan-Meier freedom from all-cause mortality at 24 months). The abstract does not say whether this test was prespecified or adjusted for multiple comparisons, so treat it as a secondary result. The same limits apply as for the heart-failure hospitalization claim: funded by Abbott, no masking in the registry, selected patients with secondary mitral regurgitation on maximal medicines. Only the abstract was read.

- Death from any cause (Not specified): Death from any cause within 24 months (percent of patients) 29.1 percent; reported as "29.1% of the patients in the device group"; arm MitraClip plus medical therapy, no comparator arm; interval Not applicable; denominator Not reported (basis: Percentage of the patients in the group; 302 were randomized to the device group and 312 to the control group (abstract). No event counts are given.); time window Within 24 months of follow-up (abstract)
- Death from any cause (Not specified): Death from any cause within 24 months (percent of patients) 46.1 percent; reported as "46.1% of the patients in the control group"; arm Medical therapy alone, no comparator arm; interval Not applicable; denominator Not reported (basis: Percentage of the patients in the group; 302 were randomized to the device group and 312 to the control group (abstract). No event counts are given.); time window Within 24 months of follow-up (abstract)
- Death from any cause (Not specified): Hazard ratio, device versus control 0.62 ratio; reported as "hazard ratio 0.62; 95% CI, 0.46 to 0.82; P<0.001"; arm MitraClip plus medical therapy compared with Medical therapy alone; interval 0.46 to 0.82 (95% confidence interval); denominator Not applicable (basis: Comparison of the two per-arm rows (302 versus 312 randomized)); time window Within 24 months of follow-up (abstract)

## Connected pages

- Registry intervention: MitraClip System: MitraClip (`cardio:mitraclip`)
- Registry condition: mitral regurgitation: Mitral regurgitation (`cardio:mitral-regurgitation`)
- Lead sponsor on the registry record: Abbott (`cardio:abbott`)
- Funder named in the abstract: Abbott (`cardio:abbott`)
- Studies people with this condition: Heart failure (`cardio:heart-failure`)
- A listed paper reports outcomes after mitral transcatheter edge-to-edge repair in the trial: Transcatheter edge-to-edge repair (TEER) (`cardio:transcatheter-edge-to-edge-repair`)

## Provenance

Content hash: 184314c157668796d953cc83e577a9f111d87184d7851459d5ad7db1655c286c
Last substantive edit: 2026-10-15
Evidence last checked: 2026-10-14