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Study of Transcatheter Tricuspid Annular Repair

NCT03692598 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-10-23

No results posted yet for this study

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.

Conditions

  • Tricuspid Regurgitation

Interventions

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

Sponsors & Collaborators

  • Micro Interventional Devices

    lead INDUSTRY

Principal Investigators

  • Kestutis Rucinskas, MD · Vilnius University Hospital, Santariskiu Klinikos

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • Denmark
  • Hungary
  • Latvia
  • Lithuania
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03692598 on ClinicalTrials.gov