Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System

NCT04614402 · tracked via the Priya Life Science Germany tracker

Sponsor

Edwards Lifesciences

Phase

Observational

Started

2021-01-15

Last updated

2026-07-16

Condition(s) studied

Tricuspid Valve Insufficiency

Investigational drug(s) / intervention(s)

Edwards PASCAL Transcatheter Valve Repair SystemEdwards PASCAL Precision Transcatheter Valve Repair System

Edwards PASCAL Transcatheter Valve Repair System: The Edwards PASCAL Valve Repair System is indicated for the percutaneous reconstruction of an insufficient tricuspid valve.

Edwards PASCAL Precision Transcatheter Valve Repair System: The Edwards PASCAL Precision Valve Repair System is indicated for the percutaneous reconstruction of an insufficient tricuspid valve.

Study summary

This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter tricuspid valve repair.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Patient is a candidate for transcatheter tricuspid valve repair as determined by a Heart Team 2. TR grade ≥3+ (5 grade classification) 3. Patient is eligible to receive the PASCAL device per the current approved indications for use Exclusion Criteria: 1. Tricuspid valve anatomic contraindications, including previous tricuspid valve replacement 2. Severe aortic, mitral, and/or pulmonic valve stenosis and/or regurgitation 3. Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator 4. Any patient considered to be part of a vulnerable population

Primary outcome measure(s)

Number of patients with major adverse events (MAE rates) — 30 days
The primary safety endpoint is the proportion of patients with major adverse events (MAEs) at 30 days
Change in tricuspid regurgitation severity (scale of 0-5) by echocardiography — Discharge: defined as discharge or 7 days post-procedure, whichever comes first
Reduction in TR severity as assessed by TEE pre and post-implant in the procedure room. TR severity compared to baseline will be assessed by TR grade at each follow-up interval.

Trial sites (15)

Facility	City	Region
Universitätsklinikum Tübingen Innere Medizin III - Kardiologie und Angiologie	Tübingen	Baden-Wurttemberg
Universitätsklinikum Ulm Innere Medizin II	Ulm	Baden-Wurttemberg
Medizinische Klinik I- Campus Grosshadern	München	Bavaria
Herzzentrum Universitätsklinikum Köln	Cologne	DEU
Westdeutsches Herz- und Gefäßzentrum Klinik für Kardiologie und Angiologie	Essen	Nordrhine Westfalia
Herz- und Diabeteszentrum NRW - Bad Oeynhausen	Bad Oeynhausen	North Rhine-Westphalia
Herzzentrum der Universitätsklinik Bonn	Bonn	North Rhine-Westphalia
Heart Centre of the University Leipzig	Leipzig	Saxony
Zentralklinik Bad Berka GmbH	Bad Berka	Thuringia
UKE Hamburg	Hamburg	Germany
Kath. Marienkrankenhaus Hamburg gGmbH	Hamburg	Germany
University Heart Center Lübeck	Lübeck	Germany
Hygeia Hospital	Athens	Greece
Ospedale del Cuore "G. Pasquinucci"	Massa	Italy
Inselspital	Bern	Switzerland

More Edwards Lifesciences trials in Germany

KONECT RESILIA Aortic Valved Conduit (AVC) Real-world Study Assessing Safety and Performance Recruiting

Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial Active, not recruiting

Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve Active, not recruiting

MiCLASP Post Market Clinical Follow-Up (PMCF) Study Active, not recruiting

SAPIEN 3 Ultra System PMCF Active, not recruiting

Other trials for the same condition

German Registry for Transcatheter Tricuspid Valve Interventions Recruiting

Retrospective Prospective Multicentric Clinical Follow up of Patients After Being Treated With TricValve® Recruiting

Evaluation of the Impact of Interventional Treatments for Symptomatic, Severe Tricuspid Valve Insufficiency on Renal Integrity and Function, as Well as on Physical Function and Activity in Older Adults. Recruiting

TRISCEND II Pivotal Trial Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04614402 on ClinicalTrials.gov ↗ ← All trials in Germany