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

NCT05628779 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: NL81645.100.22
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 6

Brief Summary

This is a national multicenter, open-label, randomized controlled trial to show superiority of edge-to-edge Transcatheter Tricuspid Valve repair (TTVr) on top of the Standard Of Care (SOC; heart failure medication) over the SOC alone in patients with symptomatic severe Tricuspid Regurgitation (TR) in the Netherlands.

Conditions

Tricuspid Valve Regurgitation, Nonrheumatic; Cardiac Catheterization; Heart Failure, Right Sided; Valve Regurgitation, Tricuspid

Keywords

Transcatheter tricuspid valve repair; Tricuspid valve regurgitation; Tricuspid valve; Leaflet approximation devices

Outcome Measures

Primary Outcomes (1)

• Hierarchical composite of all-cause mortality, heart failure hospitalization and Quality of Life

  Quality of Life is measured with the Kansas City Cardiomyopathy Questionnaire with a 5 point change as clinically significant (0-100 points, higher score is better outcome)

  12 months

Secondary Outcomes (8)

• All-cause mortality

  12 months

• Hospitalization for heart failure

  12 months

• Change in Kansas City Cardiomyopathy Questionnaire

  12 months

• Number of participants without Major Adverse Events (MAE)

  30 days and 12 months

• Change in New York Heart Association

  12 months

Study Arms (2)

Transcatheter Edge-to-Edge Repair (TEER) on top of the Standard Of Care (SOC)

EXPERIMENTAL

Transcatheter Edge-to-Edge Repair (TEER) on top of the Standard Of Care (SOC)

Device: TriClip TTVr system (Abbott Vascular); Device: PASCAL TTVr system (Edwards Lifesciences)

Standard Of Care (SOC)

NO INTERVENTION

Patients will continue the SOC with heart failure medication following the European Society of Cardiology guideline 2021 recommendations (e.g. diuretics)

Interventions

TriClip TTVr system (Abbott Vascular) DEVICE

Edge-to-edge leaflet approximation for the tricuspid valve

Transcatheter Edge-to-Edge Repair (TEER) on top of the Standard Of Care (SOC)

PASCAL TTVr system (Edwards Lifesciences) DEVICE

Edge-to-edge leaflet approximation for the tricuspid valve

Transcatheter Edge-to-Edge Repair (TEER) on top of the Standard Of Care (SOC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.
• The patient is ≥18 years of age at time of consent.
• The patient must provide written informed consent prior to any trial related procedure.

You may not qualify if:

• 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.
• 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.
• 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.
• Tricuspid valve stenosis - Defined as a tricuspid valve orifice of ≤ 1.0 cm2 and/or mean gradient ≥5 mmHg.
• Left Ventricular Ejection Fraction (LVEF) ≤20%
• 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)
• Myocardial infarction known unstable angina, or percutaneous coronary intervention within prior 30 days.
• 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).
• Cerebrovascular Accident (CVA) within prior 90 days
• Chronic dialysis
• Bleeding disorders or hypercoagulable state, inability to use dual antithrombotic therapy due to contraindication, allergy or hypersensitivity
• Active peptic ulcer or active gastrointestinal (GI) bleeding
• Life expectancy of less than 12 months
• Subject currently participating in another clinical trial (not yet completed primary endpoint) or in another clinical investigation for valvular heart disease.
• 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.

Sponsors & Collaborators

• St. Antonius Hospital: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (6)

Amsterdam UMC

Amsterdam, Netherlands

Location

UMC Groningen

Groningen, Netherlands

Location

Leiden UMC

Leiden, Netherlands

Location

Maastricht UMC+

Maastricht, Netherlands

Location

St. Antonius Hospital Nieuwegein

Nieuwegein, Netherlands

Location

Erasmus University Medical Center

Rotterdam, Netherlands

Location

MeSH Terms

Conditions

Tricuspid Valve Insufficiency; Heart Failure

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• M.J. Swaans, MD,PhD

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Randomized controlled trial with open-label extension
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A total of 150 patients will be randomly assigned with a 2:1 allocation to either interventional (n=100) or control group (n=50).

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 29, 2022
• Study Start: December 12, 2022
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After publishing the main study articles, raw and modified data can be made available at request
• Access Criteria: These criteria will be made in consultation with the legal advisor of our institution and have not yet been drafted. Specific degrees in the field of research have to be demonstrated, as wel as links with hospitals or research institutes of the researcher/physician (e.g. an employee contract)

Locations

NL (6)