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, France, Germany98 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 range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)
. 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.
. Severe uncontrolled hypertension (Systolic blood pressure \[SBP\] ≥ 180 mmHg and/or Diastolic blood pressure \[DBP\] ≥ 110 mm Hg).