Who is sponsoring NCT05628779?

NCT05628779 is sponsored by St. Antonius Hospital.

What drugs are being tested in NCT05628779?

Interventions in NCT05628779: TriClip TTVr system (Abbott Vascular), PASCAL TTVr system (Edwards Lifesciences).

What condition does NCT05628779 study?

NCT05628779 studies Tricuspid Valve Regurgitation, Nonrheumatic, Cardiac Catheterization, Heart Failure, Right Sided, Valve Regurgitation, Tricuspid.

Is NCT05628779 still recruiting?

NCT05628779 is currently enrolling by invitation. Last updated 16 February 2024.

Last reviewed 2024-02-16 · How we verify

NCT05628779: TRACE-NL

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

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

ENROLLING BY INVITATION NA Last updated 16 February 2024

What this trial tests

NA trial testing TriClip TTVr system (Abbott Vascular) in Tricuspid Valve Regurgitation, Nonrheumatic in 150 participants. Enrolling by invitation.

Timeline

12 December 2022

Primary endpoint
1 November 2027

1 November 2027

Quick facts

Lead sponsor	St. Antonius Hospital
Phase	NA
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	150
Start date	12 December 2022
Primary completion	1 November 2027
Estimated completion	1 November 2027
Sites	6 locations across Netherlands

Drugs / interventions tested

TriClip TTVr system (Abbott Vascular)
PASCAL TTVr system (Edwards Lifesciences)

Conditions studied

Tricuspid Valve Regurgitation, Nonrheumatic — all drugs for Tricuspid Valve Regurgitation, Nonrheumatic →
Cardiac Catheterization — all drugs for Cardiac Catheterization →
Heart Failure, Right Sided — all drugs for Heart Failure, Right Sided →
Valve Regurgitation, Tricuspid — all drugs for Valve Regurgitation, Tricuspid →

Sponsor

St. Antonius Hospital

Who can join

18 and older, any sex, with Tricuspid Valve Regurgitation, Nonrheumatic or Cardiac Catheterization. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

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

The Diagnosis and Treatment of Tricuspid Regurgitation.
Stocker TJ, Besler C, Treede H, Hausleiter J. · · 2024 · cited 1× · PMID 38895810 · DOI 10.3238/arztebl.m2024.0104
Tricuspid valve edge to edge repair vs replacement - a comparative analysis and future directions.
Hajj J, Kassab J, Zalaquett Z, Harb SC, et al · · 2026 · PMID 40779241 · DOI 10.1080/14796678.2025.2545133

Verify or expand the search:

Other St. Antonius Hospital trials

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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 NCT05628779 (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 St. Antonius Hospital
Last refreshed: 16 February 2024

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/NCT05628779.

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