NCT04141137

TRICUS STUDY Euro - Safety and Efficacy of the TricValve® Device

Completed NA Last updated 20 April 2022

What this trial tests

NA trial testing TricValve® System in Severe Tricuspid Regurgitation in 35 participants. Completed in 2 December 2021.

Timeline

9 December 2019

Primary endpoint
5 May 2021

2 December 2021

Quick facts

Lead sponsor	P+F Products + Features GmbH
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	35
Start date	9 December 2019
Primary completion	5 May 2021
Estimated completion	2 December 2021
Sites	10 locations across Austria, Spain

Drugs / interventions tested

• TricValve® System

Conditions studied

• Severe Tricuspid Regurgitation — all drugs for Severe Tricuspid Regurgitation →

Sponsor

P+F Products + Features GmbH

Who can join

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

Sponsor's own description

The TricValve® Transcatheter Bicaval Valves System is indicated for relief of tricuspid insufficiency in patients with symptomatic heart disease who are judged by a heart team, including a cardiac surgeon, to be at extreme risk or inoperable for open surgical therapy.

Publications & conference data

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

1. Update on Transcatheter Tricuspid Valve Replacement Therapies.
   Goldberg YH, Ho E, Chau M, Latib A. · · 2021 · cited 33× · PMID 33659278 · DOI 10.3389/fcvm.2021.619558
2. Caval Valve Implantation (CAVI): An Emerging Therapy for Treating Severe Tricuspid Regurgitation.
   Abdul-Jawad Altisent O, Benetis R, Rumbinaite E, Mizarien V, et al · · 2021 · cited 27× · PMID 34640619 · DOI 10.3390/jcm10194601
3. Transcatheter tricuspid valve interventions: Current status and future perspectives.
   Alperi A, Almendárez M, Álvarez R, Moris C, et al · · 2022 · cited 19× · PMID 36187002 · DOI 10.3389/fcvm.2022.994502
4. Future Perspectives in Percutaneous Treatment of Tricuspid Regurgitation.
   Mangieri A, Pagnesi M, Regazzoli D, Laricchia A, et al · · 2020 · cited 15× · PMID 33173788 · DOI 10.3389/fcvm.2020.581211
5. Current Status of Transcatheter Tricuspid Valve Therapies.
   Romeo JD, Bashline MJ, Fowler JA, Kliner DE, et al · · 2022 · cited 10× · PMID 36275351 · DOI 10.17925/hi.2022.16.1.49
6. Transcatheter Caval Valve Implantation for Tricuspid Regurgitation After Single Leaflet Device Attachment.
   Rroku A, Barbieri F, Landmesser U, Skurk C, et al · · 2022 · cited 6× · PMID 35493801 · DOI 10.1016/j.jaccas.2022.02.014
7. 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
8. Transcatheter Tricuspid Valve Intervention: Current Perspective.
   Simard TJ, Eleid MF. · · 2021 · cited 3× · PMID 39720492 · DOI 10.15420/usc.2020.26