Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve Repair System Pivotal

  • STATUS
    Recruiting
  • End date
    Mar 17, 2027
  • participants needed
    700
  • sponsor
    Abbott Medical Devices
Updated on 17 September 2022
medical therapy
regurgitation
heart failure
diuretics
fibrillation
mitral regurgitation
tricuspid valve repair
repair of tricuspid valve

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).

Details
Condition Tricuspid Regurgitation
Treatment Tricuspid valve repair
Clinical Study IdentifierNCT03904147
SponsorAbbott Medical Devices
Last Modified on17 September 2022

Eligibility

Yes No Not Sure

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
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
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
In the judgment of the TriClip(TM) implanting Investigator, femoral vein access is determined to be feasible and can accommodate a 25 Fr catheter
severity will need to be re-assessed 30 days after the cardiac procedure(s)
Subject must provide written informed consent prior to any trial related procedure
Age ≥18 years at time of consent

Exclusion Criteria

Systolic pulmonary artery pressure (sPAP) > 70 mmHg or fixed pre-capillary pulmonary hypertension as assessed by right heart catheterization (RHC)
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) device
Severe uncontrolled hypertension Systolic Blood Pressure (SBP) ≥ 180 mmHg and/or Diastolic Blood Pressure (DBP) ≥ 110 mm Hg)
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
Tricuspid valve stenosis - Defined as a tricuspid valve orifice of ≤ 1.0 cm2 and/or mean gradient ≥5 mmHg as measured by the ECL
Severe leaflet defect(s) preventing proper device placement
Left Ventricular Ejection Fraction (LVEF) ≤20%
Ebstein Anomaly - Identified by having a normal annulus position while the valve leaflets are attached to the walls and septum of the right ventricle
Tricuspid valve anatomy not evaluable by TTE and TEE
Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e. noncompliant, perforated)
MI or known unstable angina within prior 30 days
Percutaneous coronary intervention within prior 30 days
Hemodynamic instability defined as systolic pressure < 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device
Cerebrovascular Accident (CVA) within prior 90 days
Chronic dialysis
Bleeding disorders or hypercoagulable state
Active peptic ulcer or active gastrointestinal (GI) bleeding
Contraindication, allergy or hypersensitivity to dual antiplatelet and anticoagulant therapy
Note: Contraindication to either antiplatelet or anticoagulant therapy (individually not both therapies) is not an exclusion criterion
Known allergy or hypersensitivity to device materials
Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation
Life expectancy of less than 12 months
Subject is currently participating in another clinical trial that has not yet completed its primary endpoint
Ongoing infection requiring current antibiotic therapy (if temporary illness, patients
Subject is currently participating in another clinical investigation for valvular heart disease(s)
may enroll 30 days after discontinuation of antibiotics with no active
Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period. Female subjects of child-bearing potential are required to have a negative pregnancy test done within 7 days of the baseline visit per site standard test. Female patients of childbearing potential should be instructed to use safe contraception (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release.) It is accepted, in certain cases, to include subjects having a sterilized regular partner or subjects using a double barrier contraceptive method
infection)
Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results
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