NCT02098200

Percutaneous Treatment of Tricuspid Valve Regurgitation With the TriCinch System™

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: 4Tech Cardio Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The TriCinch System™ is intended for percutaneous treatment of tricuspid regurgitation. It is a percutaneous catheter-based device designed for tricuspid valve repair in order to decrease effective cross-sectional area and relieve symptoms in patients with tricuspid valve regurgitation.

Detailed description

Implantation Procedure: Unlike the standard open chest, arrested heart approach, the 4TECH TriCinch System™ provides a percutaneous solution for tricuspid valve regurgitation treatment: this procedure is performed through deep sedation, while the heart is beating, without the need for respiratory assistance. The TriCinch System™ consists of a Delivery System that enables transcatheter placement of an implant that can be adjusted to correct Tricuspid valve regurgitation. The TriCinch Delivery System is inserted from the femoral vein to access the right atrium of the heart. At the end of the correction process, the TriCinch Delivery System and the venous introducer are removed and the procedure is concluded.

Conditions

• Tricuspid Regurgitation

Interventions

Type	Name	Description
DEVICE	TriCinch System	Percutaneous treatment of Tricuspid Regurgitation

Timeline

• Start date: 2013-06-01
• Primary completion: 2016-11-01
• Completion: 2017-10-01
• First posted: 2014-03-27
• Last updated: 2018-03-14

Locations

14 sites across 4 countries: France, Germany, Italy, Netherlands