Trial to Evaluate Treatment With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater Tricuspid Regurgitation (TRILUMINATE)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Tricuspid Valve Insufficiency
- Sponsor
- Abbott Medical Devices
- Enrollment
- 98
- Locations
- 20
- Primary Endpoint
- Number of Participants With Echocardiographic Tricuspid Regurgitation Reduction at Least 1 Grade
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Detailed Description
This is a prospective, single arm, multi-center study. A minimum of 85 subjects will be prospectively enrolled into this single arm study in approximately 25 sites, in Europe, Canada and the United States. Patients will be seen for follow-up visits at discharge (≤ 7 days post index procedure), 30 days, 6 months, 1,2,3 years.
Investigators
Eligibility Criteria
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.
- •The Site Heart Team concur the benefit-risk analysis supports intervention for tricuspid regurgitation per current guidelines for the management of Valvular heart disease and that the subject is at high risk for tricuspid valve surgery.
- •In the judgement of the TVRS implanting investigator, femoral vein access is determined to be feasible and can accommodate a 25 Fr catheter.
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).
- •Systolic Pulmonary Artery Pressure \> 60 mmHg (echo determined).
- •Prior tricuspid valve leaflet surgery or any currently implanted prosthetic tricuspid valve, or any prior transcatheter tricuspid valve procedure.
- •Mitral Regurgitation moderate-severe or greater severity (≥3+).
- •Pacemaker or implantable cardioverter-defibrillator (ICD) leads that would prevent appropriate placement of TVRS Clip.
- •Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease.
- •Myocardial Infarction (MI) or known unstable angina within prior 30 days prior to enrollment.
- •Percutaneous coronary intervention within prior 30 days prior to enrollment.
Outcomes
Primary Outcomes
Number of Participants With Echocardiographic Tricuspid Regurgitation Reduction at Least 1 Grade
Time Frame: At 30 days
Tricuspid regurgitation (TR) was assessed with standard 2D color doppler methods using a integrative approach. A five-class grading scheme was used: mild, moderate, severe, massive and torrential. Parameters including vena contracta area, effective regurgitant orifice area and proximal isovelocity surface area were used to quantify and grade TR.
Number of Participants With Composite of Major Adverse Event (MAE)
Time Frame: At 6 months
Major Adverse Event (MAE) is defined as a composite of: * Cardiovascular Mortality * Myocardial Infarction (MI) * Stroke * New onset renal failure * Endocarditis requiring surgery, and * Non-elective cardio-vascular (CV) surgery for TVRS device-related AE post-procedure