NCT03692598

Study of Transcatheter Tricuspid Annular Repair

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Micro Interventional Devices · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the safety and performance of the MIA Minimally Invasive Annuloplasty Device in patients with chronic functional tricuspid regurgitation.

Detailed description

The purpose of the study is to evaluate the safety and performance of the MIA Minimally Invasive Annuloplasty Device in patients with chronic functional tricuspid regurgitation. The study is a prospective, multi-center safety and performance study. Enrolled subjects will be assessed for clinical follow-up at 1 month, 6 months, and 1 year post implant procedure.

Conditions

• Tricuspid Regurgitation

Interventions

Type	Name	Description
DEVICE	MIA, Minimally Invasive Annuloplasty Device - Surgical	Eligible patients will receive implantation of MIA implants deployed using the MIA, Minimally Invasive Annuloplasty Device from an open surgical approach
DEVICE	MIA, Minimally Invasive Annuloplasty Device - Percutaneous	Eligible patients will receive implantation of MIA implants deployed using the MIA, Minimally Invasive Annuloplasty Device from a percutaneous approach

Timeline

• Start date: 2016-12-01
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2018-10-02
• Last updated: 2024-10-23

Locations

6 sites across 5 countries: Denmark, Hungary, Latvia, Lithuania, Poland