Evaluating Edge-to-edge Transcatheter Tricuspid Valve Repair in Patients With Severe Symptomatic Tricuspid Regurgitation

Launched by ST. ANTONIUS HOSPITAL · Nov 16, 2022

Keywords

ClinConnect Summary

This is a national, multicenter, randomized study in the Netherlands testing whether adding a transcatheter edge-to-edge repair (TEER) procedure to standard heart failure care helps people with severe tricuspid valve regurgitation (TR) feel better and avoid serious problems. In TEER, doctors use a small device to help the tricuspid valve close more effectively, which may reduce leakage. About 150 adults with symptomatic, severe TR that hasn’t responded well to usual medicines are being split 2:1 into two groups: TEER plus standard care (SOC) versus SOC alone. The trial sites include several Dutch centers, such as Amsterdam UMC, UMC Groningen, Leiden UMC, Maastricht UMC+, St. Antonius Hospital Nieuwegein, and Erasmus MC in Rotterdam. Results are not yet reported.

What to expect if you join or consider this trial: participants will be randomly assigned to receive either the TEER procedure (using devices like TriClip or PASCAL) on top of ongoing heart failure treatment, or to continue SOC alone. Everyone gets follow-up for at least a year. The main goal is to see if TEER improves a combined outcome of survival, fewer hospitalizations for heart failure, and better quality of life (measured by the Kansas City Cardiomyopathy Questionnaire, where a 5-point change is considered meaningful). Other important measures include overall mortality, hospitalizations for heart failure, changes in heart function and exercise ability, the amount of tricuspid valve leakage, safety events, and a look at cost-effectiveness. The study is open-label (no placebo), and it is currently enrolling by invitation with an estimated completion in 2027. If you’re interested, talk with your heart team about whether you might be eligible.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. The patient is symptomatic (New York Heart Association Functional Class II, III or ambulatory class IV) despite Standard Of Care (SOC). The Central Screening Committee (CSC) will assess whether the patient is receiving SOC. The CSC will also ensure that in case of the presence of atrial fibrillation, left sided heart valve disease (not requiring intervention) or coronary artery disease, conditions are first treated adequately with medication and/or (surgical) intervention.
• • 2. The patient suffers from ≥ grade 3 isolated TR as determined by the assessment of a qualifying transthoracic echocardiogram (TTE) and three-dimensional transesophageal echocardiogram (3DTEE) and confirmed by the CSC, according to European Association for Percutaneous Cardiovascular Interventions (Tricuspid Focus Group) consensus document (in press). Note: If cardiac procedure(s) occur after eligibility was determined, TR grade will be re-assessed 30 days after the procedure.
• • 3. The cardiac surgeon of the sites' local heart team concurs that the patient is at high estimated risk for mortality or morbidity with TV surgery.
• • 4. The patient is ≥18 years of age at time of consent.
• • 5. The patient must provide written informed consent prior to any trial related procedure.
• Exclusion Criteria:
• • 1. Systolic pulmonary artery pressure (sPAP) \> 70 mmHg or fixed pre-capillary pulmonary hypertension as assessed by right heart catheterization. Severe uncontrolled hypertension Systolic Blood Pressure (SBP) ≥ 180 mmHg and/or Diastolic Blood Pressure (DBP) ≥ 110 mmHg.
• • 2. Any condition that would interfere with a TTVr procedure, such as prior tricuspid valve repair or tricuspid valve leaflet anatomy which may preclude device implantation (e.g. calcification in grasping area, a severe coaptation defect of the tricuspid leaflets (no clip placement possible), pacemaker or Implantable Cardioverter Defibrillator (ICD) leads that would prevent appropriate placement or visualization of TTVr devices, Ebstein Anomaly (normal annulus position, but valve leaflets attached to walls and septum of the right ventricle), tricuspid valve anatomy non evaluable by echo, known allergy or hypersensitivity to dual antiplatelet therapy AND anticoagulant therapy or to device materials, femoral venous mass or thrombus or vegetation.
• • 3. Indication for left-sided (e.g. severe aortic stenosis, severe mitral regurgitation) or pulmonary valve correction within prior 60 days. Note: concomitant mitral valve disease (e.g. mitral regurgitation) will be treated first and patients will be reassessed for the trial after 60 days.
• • 4. Tricuspid valve stenosis - Defined as a tricuspid valve orifice of ≤ 1.0 cm2 and/or mean gradient ≥5 mmHg.
• • 5. Left Ventricular Ejection Fraction (LVEF) ≤20%
• • 6. Active endocarditis, active rheumatic heart disease, other ongoing infection requiring antibiotic therapy (enrolment possible 30 days after discontinuation of antibiotics with no active infection) or leaflets degenerated from rheumatic disease (i.e. noncompliant, perforated)
• • 7. Myocardial infarction known unstable angina, or percutaneous coronary intervention within prior 30 days.
• • 8. Hemodynamic instability defined as systemic systolic pressure \<90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or hemodynamic support device (e.g. intra-aortic balloon pump).
• • 9. Cerebrovascular Accident (CVA) within prior 90 days
• • 10. Chronic dialysis
• • 11. Bleeding disorders or hypercoagulable state, inability to use dual antithrombotic therapy due to contraindication, allergy or hypersensitivity
• • 12. Active peptic ulcer or active gastrointestinal (GI) bleeding
• • 13. Life expectancy of less than 12 months
• • 14. Subject currently participating in another clinical trial (not yet completed primary endpoint) or in another clinical investigation for valvular heart disease.
• • 15. Pregnant or nursing patients or those who plan pregnancy during the course of the trial. Women of childbearing age are required to have a negative pregnancy test 7 days prior to baseline visit. Women of childbearing age should be instructed to use safe contraception or have a sterilized regular partner.
• • 16. Presence of anatomic or comorbid conditions, or other medical, social or psychological conditions that, in the eye of the investigator, limits the subject's ability to participate in the clinical investigation or comply with follow-up requirements, or impact the scientific soundness of the investigation results.