Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve Repair System Pivotal
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Tricuspid Regurgitation
- Sponsor
- Abbott Medical Devices
- Enrollment
- 572
- Locations
- 76
- Primary Endpoint
- For Randomized Cohort: Hierarchical Composite of All-cause Death or Tricuspid Valve Surgery, Heart Failure Hospitalizations, and KCCQ Improvement
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
Brief 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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •In the judgment of the site local heart team, subject has been adequately treated per applicable standards (including medical management) and stable for at least 30 days as follows:
- •Optimized medical therapy for treatment of TR (e.g. diuretics).
- •Medical and/or device therapy, for mitral regurgitation, atrial fibrillation, coronary artery disease and heart failure.
- •The Eligibility Committee will confirm that the subject has been adequately treated medically.
- •Subject is symptomatic with Severe TR despite being optimally treated as described above. TR severity is determined by the assessment of a qualifying TTE and confirmed by the ECL. The ECL will also request a TEE to confirm TR etiology. Note: If any cardiac procedure(s) occur after eligibility was determined, TR severity will need to be re-assessed 30 days after the cardiac procedure(s).
- •The cardiac surgeon of the site local heart team concur that the patient is at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery.
- •New York Heart Association (NYHA) Functional Class II, III or ambulatory class IV
- •In the judgment of the TriClip(TM) implanting Investigator, femoral vein access is determined to be feasible and can accommodate a 25 Fr catheter.
- •Age ≥18 years at time of consent.
- •Subject must provide written informed consent prior to any trial related procedure.
Exclusion Criteria
- •Systolic pulmonary artery pressure (sPAP) \> 70 mmHg or fixed pre-capillary pulmonary hypertension as assessed by right heart catheterization (RHC)
- •Severe uncontrolled hypertension Systolic Blood Pressure (SBP) ≥ 180 mmHg and/or Diastolic Blood Pressure (DBP) ≥ 110 mm Hg
- •Any prior tricuspid valve procedure that would interfere with placement of the TriClip(TM) device
- •Indication for left-sided (e.g. severe aortic stenosis, severe mitral regurgitation) or pulmonary valve correction prior 60 days. Note: Patients with concomitant Mitral and tricuspid valve disease will have the option of getting their MR treated, and wait 60 days prior to being reassessed for the trial.
- •Pacemaker or ICD leads that would prevent appropriate placement of the TriClip(TM) clip.
- •Tricuspid valve stenosis - Defined as a tricuspid valve orifice of ≤ 1.0 cm2 and/or mean gradient ≥5 mmHg as measured by the ECL
- •Left Ventricular Ejection Fraction (LVEF) ≤20%
- •Tricuspid valve leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets or sufficient reduction in TR. This may include:
- •Evidence of calcification in the grasping area
- •Presence of a severe coaptation defect (\> 2cm) of the tricuspid leaflets
Outcomes
Primary Outcomes
For Randomized Cohort: Hierarchical Composite of All-cause Death or Tricuspid Valve Surgery, Heart Failure Hospitalizations, and KCCQ Improvement
Time Frame: 12 Months
Analysis of hierarchical composite of all-cause death or tricuspid valve surgery, heart failure hospitalizations, and KCCQ improvement of at least 15 points was performed in ITT population using Finkelstein-Schoenfeld method. A win ratio was also calculated to descriptively quantify the magnitude of treatment benefits. The win ratio is calculated as the ratio of the number of wins in Device versus Control patients. The primary analysis population consisted of 175 Device patients and 175 Control patients, resulting in 30,625 Device-Control patient pairs (i.e., 175 × 175).
For Single-Arm Cohort: Rate of Survival Through 12 Months With a Quality of Life Improvement (Assessed Using KCCQ Overall Score) of at Least 10 Points Compared to Baseline.
Time Frame: 12 months
This outcome will be assessed as the percentage of subjects meeting the definition of the endpoint.
Secondary Outcomes
- For Single-Arm Cohort: The Percentage of Subjects With TR Reduction by at Least 1 Grade at 30-Day Follow-up(30 days)
- For Randomized Cohort: Change in Quality of Life as Assessed by KCCQ Score(12 months minus baseline)
- For Randomized Cohort - Device Group Only: Rate of Kaplan-Meier Estimate (SE) of Freedom From Major Adverse Events (MAE) Occurring Within 30 Days Post-procedure(30 Days)
- For Randomized Cohort: Tricuspid Regurgitation Reduction to Moderate or Less at 30-Day Visit(30 Days)
- Recurrent HF Hospitalizations at 24 Months(24 months)
- Freedom From All-cause Mortality, Tricuspid Valve Surgery, and Tricuspid Valve Intervention at 24 Months(24 months)
- For Randomized Cohort: Change in 6 Minute Walk Test (6MWT) From Baseline to 12 Months(12 Months)
- For Single-Arm Cohort: Rate of Freedom From MAE Through 30 Days(30 days)
- For Single-Arm Cohort: Change in 6 Minute Walk Test (6MWT) From Baseline to 12 Months(12 months)