NCT03632967

Early Feasibility Study of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System

Terminated NA Last updated 31 July 2020

What this trial tests

NA trial testing Tricinch Coil System Implantation in Functional Tricuspid Regurgitation in 7 participants. Terminated before completion.

Timeline

12 September 2018

Primary endpoint
14 July 2020

14 July 2020

Quick facts

Lead sponsor	4Tech Cardio Ltd.
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	7
Start date	12 September 2018
Primary completion	14 July 2020
Estimated completion	14 July 2020
Sites	9 locations across United States

Drugs / interventions tested

• Tricinch Coil System Implantation

Conditions studied

• Functional Tricuspid Regurgitation — all drugs for Functional Tricuspid Regurgitation →
• Heart Valve Diseases — all drugs for Heart Valve Diseases →
• Tricuspid Valve Insufficiency — all drugs for Tricuspid Valve Insufficiency →

Sponsor

4Tech Cardio Ltd.

Who can join

18 and older, any sex, with Functional Tricuspid Regurgitation or Heart Valve Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary objective of the study is to generate feasibility safety and performance data for the 4Tech TriCinch Coil System in symptomatic patients suffering from moderate to severe functional tricuspid regurgitation with annular dilatation.

The TriCinch Coil System is a percutaneous catheter-based medical device for tricuspid valve repair.

Publications & conference data

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

1. Update on the Current Landscape of Transcatheter Options for Tricuspid Regurgitation Treatment.
   Curio J, Demir OM, Pagnesi M, Mangieri A, et al · · 2019 · cited 32× · PMID 31178930 · DOI 10.15420/icr.2019.5.1
2. Advances in transcatheter mitral and tricuspid therapies.
   Overtchouk P, Piazza N, Granada J, Soliman O, et al · · 2020 · cited 25× · PMID 31910809 · DOI 10.1186/s12872-019-01312-3
3. 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
4. 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