Cardiovascular Atlas
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TRILUMINATE Pivotal trial

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.

Also called TRILUMINATE Pivotal · TRILUMINATE

  • Study
  • In this atlas

Overview

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, retrieved )
  • 350 patients (enrolled count) (Transcatheter Repair for Patients with Tricuspid Regurgitation, retrieved )
Sponsor
  • Abbott Lead sponsor on the registry record
Funder
  • Abbott Funder named in the abstract
Registry
  • NCT NCT03904147
Started
(actual) (TRILUMINATE Pivotal Trial, retrieved )
Primary completion
(actual) (TRILUMINATE Pivotal Trial, retrieved )
Completion
(anticipated) (TRILUMINATE Pivotal Trial, retrieved )
Results first posted
(actual) (TRILUMINATE Pivotal Trial, retrieved )
Countries
United States, Canada, Germany, Italy, Spain (TRILUMINATE Pivotal Trial, retrieved )
Care setting
65 centers in the United States, Canada and Europe (abstract). (Transcatheter Repair for Patients with Tricuspid Regurgitation, retrieved )
Registry status
  • “ACTIVE_NOT_RECRUITING” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

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.

Arms

  • TriClip plus medical therapy

    Intervention TriClip

    Randomized device group: TriClip implantation with continued medical therapy at the physician's discretion (registry).

  • Medical therapy alone

    Intervention None named

    Randomized control group: continued medical therapy at the physician's discretion (registry). No separate intervention record exists for this comparison.

Findings

No findings are published for this study.

Record details

Record id
cardio:triluminate
Content hash
2c2a4aa15cb6879520f67963c73de916f5c65d1635368365dbcecb9e9d7b9b85