TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Great… (NCT03227757) | Clinical Trial Compass
CompletedNot Applicable
TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR
United States, France98 participantsStarted 2017-08-01
Plain-language summary
The primary purpose of this study is to evaluate safety and effectiveness of the Tricuspid Valve Repair System (TVRS) for treating symptomatic moderate or greater tricuspid regurgitation (TR) in patients currently on medical management and who are deemed appropriate for percutaneous transcatheter intervention.
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion criteria
✓. Subject must be ≥18 years and ≤ 90 years at time of consent and must not be a member of a vulnerable population.
✓. Subject or a legally authorized representative (where allowed per local regulations) must provide written informed consent prior to any trial related procedure.
✓. Subject must agree not to participate in any other clinical trial for a period of one year following the index procedure.
✓. In the judgment of the investigator at the site, the subject has been adequately treated per applicable standards, including for coronary artery disease, mitral regurgitation and heart failure at least 30-days prior to index procedure. The Eligibility Committee must concur that the subject has been adequately treated.
✓. New York Heart Association (NYHA) Functional Class II (conditional), III, or ambulatory IV
✓. Subjects with moderate TR: Only NYHA Class III or IV may be considered
✓. Subjects with severe or greater TR: NYHA II, III, or IV may be considered for inclusion
✓. No indication for left-sided or pulmonary valve correction.
Exclusion criteria
✕. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
✕. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
What they're measuring
1
Number of Participants With Echocardiographic Tricuspid Regurgitation Reduction at Least 1 Grade
Timeframe: At 30 days
2
Number of Participants With Composite of Major Adverse Event (MAE)