Who is sponsoring NCT04614402?

NCT04614402 is sponsored by Edwards Lifesciences.

What drugs are being tested in NCT04614402?

Interventions in NCT04614402: Edwards PASCAL Transcatheter Valve Repair System, Edwards PASCAL Precision Transcatheter Valve Repair System.

What condition does NCT04614402 study?

NCT04614402 studies Tricuspid Valve Insufficiency.

Is NCT04614402 still recruiting?

NCT04614402 is currently active, enrolled. Last updated 2 July 2025.

Last reviewed 2025-07-02 · How we verify

NCT04614402: TriCLASP

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Active, enrolled Last updated 2 July 2025

What this trial tests

trial testing Edwards PASCAL Transcatheter Valve Repair System in Tricuspid Valve Insufficiency in 300 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

15 January 2021

Primary endpoint
20 April 2023

15 March 2028

Quick facts

Lead sponsor	Edwards Lifesciences
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	300
Start date	15 January 2021
Primary completion	20 April 2023
Estimated completion	15 March 2028
Sites	15 locations across Switzerland, Italy, Greece, Germany

Drugs / interventions tested

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

Conditions studied

Tricuspid Valve Insufficiency — all drugs for Tricuspid Valve Insufficiency →

Sponsor

Edwards Lifesciences — full company profile →

Who can join

18 and older, any sex, with Tricuspid Valve Insufficiency. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Transcatheter valve repair of tricuspid regurgitation with the PASCAL system: TriCLASP study 30-day results.
Baldus S, Schofer N, Hausleiter J, Friedrichs K, et al · · 2022 · cited 28× · PMID 36378678 · DOI 10.1002/ccd.30450
Transcatheter Management of Tricuspid Regurgitation: A Review of Contemporary Evidence.
Sammour YM, Anwaar MF, Cabral-Amador F, Garcia J, et al · · 2024 · cited 3× · PMID 39885934 · DOI 10.17925/hi.2024.18.2.4

Verify or expand the search:

Other trials of Edwards PASCAL Transcatheter Valve Repair System

Trials testing the same drug.

NCT04443218 — Edwards PASCAL Transcatheter Valve Repair System Registry · completed
NCT03745313 — Edwards CLASP TR EFS · NA · completed

Other recruiting trials for Tricuspid Valve Insufficiency

Currently open trials in the same condition.

NCT06235385 — European Association of Cardiovascular Imaging Multiple and Mixed Valvular Disease Study · recruiting
NCT06196684 — Early Safety and Clinical Efficacy of Mitral Allograft in Tricuspid Surgery · active not recruiting
NCT04482062 — TRISCEND II Pivotal Trial · NA · active not recruiting
NCT04735003 — Transcatheter Interventions for Tricuspid Insufficiency in Italy · recruiting
NCT04653428 — German Registry for Transcatheter Tricuspid Valve Interventions · recruiting

Other Edwards Lifesciences trials

Trials by the same sponsor.

NCT07317648 — ClearSight NextGen1 Study · NA · completed
NCT06833476 — TTVR STRONG Under Coverage With Evidence Development (CED) Study · recruiting
NCT06569602 — Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU) · recruiting
NCT06834516 — ClearSight Baby Cuff · completed
NCT05957406 — SMART TRENDS Study · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04614402 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Edwards Lifesciences
Last refreshed: 2 July 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04614402.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing