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

NCT05628779 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-02-16

No results posted yet for this study

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

Interventions

DEVICE

TriClip TTVr system (Abbott Vascular)

Edge-to-edge leaflet approximation for the tricuspid valve

DEVICE

PASCAL TTVr system (Edwards Lifesciences)

Edge-to-edge leaflet approximation for the tricuspid valve

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • St. Antonius Hospital

    lead OTHER

Principal Investigators

  • M.J. Swaans, MD,PhD · St. Antonius Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-12
Primary Completion
2027-11-01
Completion
2027-11-01
FDA Device
Yes

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05628779 on ClinicalTrials.gov