# TRILUMINATE Pivotal trial

Study · id `cardio:triluminate` · Cardiovascular Atlas · release `5dcd9b263fe17744` (public)

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Also called: TRILUMINATE Pivotal; TRILUMINATE

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

## In plain language

A trial in 350 people with severe tricuspid regurgitation (a leaking valve between the right upper and lower chambers) and symptoms. It compared the TriClip device plus medicines against medicines alone. The combined result favored the device. Death, valve surgery and hospital stays for heart failure did not appear to differ between the groups, and the benefit came with better quality-of-life scores and less leaking. It was paid for by Abbott, the applicant for the device's US approval, and the registry lists masking of the outcome assessors only.

## Technical summary

Registry NCT03904147 (Abbott Medical Devices lead sponsor, class industry, status active but not recruiting, estimated completion 2029-04). Randomized, parallel, masking single (outcomes assessor). The registry count (572) includes a single-arm group and a continued access study; the paper reports 350 randomized and enrolled. Abstract: win ratio 1.48 (95% confidence interval 1.06 to 2.13). Findings are not tabulated: the hierarchical composite has no outcome record in this atlas.

## Key facts

- Design: Randomized, parallel-group trial of tricuspid transcatheter edge-to-edge repair plus medical therapy versus medical therapy alone. The registry records allocation as randomized, intervention model as parallel and masking as single (outcomes assessor), and adds a single-arm group and a continued access study.
- Phase: Not applicable
- Enrolled: 572 participants (enrolled count; TRILUMINATE Pivotal Trial, snapshot `cardio:ctgov-nct03904147-2026-10-14`, retrieved 2026-10-14); 350 patients (enrolled count; Transcatheter Repair for Patients with Tricuspid Regurgitation, snapshot `cardio:pubmed-36876753-2026-10-14`, retrieved 2026-10-14)
- Started: 2019-08-21 (actual) (TRILUMINATE Pivotal Trial, snapshot `cardio:ctgov-nct03904147-2026-10-14`, retrieved 2026-10-14)
- Primary completion: 2022-11-18 (actual) (TRILUMINATE Pivotal Trial, snapshot `cardio:ctgov-nct03904147-2026-10-14`, retrieved 2026-10-14)
- Completion: 2029-04 (anticipated) (TRILUMINATE Pivotal Trial, snapshot `cardio:ctgov-nct03904147-2026-10-14`, retrieved 2026-10-14)
- Results first posted: 2024-03-27 (actual) (TRILUMINATE Pivotal Trial, snapshot `cardio:ctgov-nct03904147-2026-10-14`, retrieved 2026-10-14)
- Countries: United States; Canada; Germany; Italy; Spain (TRILUMINATE Pivotal Trial, snapshot `cardio:ctgov-nct03904147-2026-10-14`, retrieved 2026-10-14)
- Care setting: 65 centers in the United States, Canada and Europe (abstract). (Transcatheter Repair for Patients with Tricuspid Regurgitation, snapshot `cardio:pubmed-36876753-2026-10-14`, retrieved 2026-10-14)
- Registry status: "ACTIVE\_NOT\_RECRUITING" (U.S. National Library of Medicine (ClinicalTrials.gov), snapshot `cardio:ctgov-nct03904147-2026-10-14`, retrieved 2026-10-14)

## Connected pages

- Registry intervention: TriClip device: TriClip (`cardio:triclip`)
- Lead sponsor on the registry record: Abbott (`cardio:abbott`)
- Funder named in the abstract: Abbott (`cardio:abbott`)
- Lists tricuspid regurgitation as its condition; the registry's derived condition tree places it under Heart Valve Diseases: Heart valve disease (`cardio:heart-valve-disease`)
- Tests percutaneous tricuspid transcatheter edge-to-edge repair: Transcatheter edge-to-edge repair (TEER) (`cardio:transcatheter-edge-to-edge-repair`)

## Provenance

Content hash: 02ac62f3e3a85bda6584cdef278f8f0643d8996ed982d14a893d59161848cf49
Last substantive edit: 2026-10-15
Evidence last checked: 2026-10-14