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TRILUMINATE Pivotal Trial

NCT03904147 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 572

Last updated 2024-12-19

Study results available
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Summary

The primary objective of this trial is to demonstrate the safety and effectiveness of the TriClip device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery. This randomized controlled trial will compare the investigational device (TriClip device) to Control (Medical Therapy).

Conditions

  • Tricuspid Regurgitation

Interventions

DEVICE

TriClipTM Device

Transcatheter TriClip placement in the tricuspid valve to repair the valve and correct regurgitation

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Meghan Griffin, PhD · Abbott Structural Heart

  • David Adams, MD · Icahn School of Medicine at Mount Sinai

  • Paul Sorajja, MD · Allina Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-21
Primary Completion
2022-11-18
Completion
2029-04-30
FDA Device
Yes

Countries

  • United States
  • Canada
  • Germany
  • Italy
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03904147 on ClinicalTrials.gov