Clinical Trials Logo
  1. Home
  2. Mitral Valve Regurgitation
  3. NCT02719912

Mitral Valve Replacement With MValve Dock and Lotus — DOCK 1  

Mitral Valve Regurgitation Clinical Trial

Official title:
Mitral Valve Replacement With the MValve Dock and A Percutaneous Transcatheter Heart Valve

Clinical Trial Summary

This study evaluates the MValve mitral prosthesis in conjunction with a Lotus transcatheter heart valve (THV) for mitral valve replacement in subjects at high risk for conventional mitral valve replacement or repair surgery.

Clinical Trial Description

This study is a prospective first in man feasibility study intended to evaluate preliminary safety and effectiveness of the MValve Mitral Dock with Lotus transcatheter heart valve for mitral valve replacement in subjects who are at high risk for surgical valve repair or replacement.

The surgical technique adapts the valve-in-valve approach for mitral replacement in degenerated mitral prostheses to failing native mitral valves. The MValve Dock is designed to provide a structural platform within the mitral annulus so that the Lotus THV can be implanted in a secure fashion in the mitral annulus. The investigational device anchors to the mitral annulus commissures, sparing the native valve leaflets and sub annular apparatus. This study is designed to treat subjects with moderate-to-severe MR who are not deemed candidates for mitral valve surgery. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02719912
Study type Interventional
Source MValve Technologies Ltd
Contact
Status Not yet recruiting
Phase N/A
Start date June 2016
Completion date July 2018
View Details
See also
  Status Clinical Trial Phase
Completed NCT02520310 - AVJ-514 Japan Trial N/A
Completed NCT02355418 - The Role of Myocardial Fibrosis in Degenerative Mitral Regurgitation
Recruiting NCT04577248 - The Prospecive OBSERVational Munich Interventional MITRAl-Valve Registry
Recruiting NCT03242642 - Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation. N/A
Recruiting NCT02961647 - Hemodynamic Stress Test in Severe Mitral Regurgitation (HEMI) N/A
Active, not recruiting NCT02302872 - Treatment of Heart Failure and Associated Functional Mitral Valve Regurgitation N/A
Completed NCT01777815 - Safety and Performance Study of the NeoChord Device N/A
Withdrawn NCT00428103 - Effects of Mitral Valve Repair With the Geoform Ring on Cardiomyopathy N/A
Completed NCT04351984 - Transcatheter Mitral Valvuloplasty Pilot Study
Withdrawn NCT02722551 - CardiAQ-Edwards™ Transcatheter Mitral Valve Replacement (TMVR) Study Phase 1/Phase 2
Active, not recruiting NCT02321514 - Expanded Clinical Study of the Tendyne Mitral Valve System N/A
Recruiting NCT02245763 - STS/ACC TVT Registry Mitral Module
Active, not recruiting NCT01740583 - Mitralign Percutaneous Annuloplasty System for Chronic Functional Mitral Valve Regurgitation N/A
Completed NCT00800046 - A Study of Percutaneous Repair of Functional Mitral Regurgitation Using the Ancora Heart, Inc. AccuCinch® Ventricular Repair System - The CINCH-2 Study N/A
Completed NCT00415701 - Effect of Etomidate on Hemodynamics and Adrenocortical Function After Cardiac Surgery Phase 4
Recruiting NCT03908983 - OPtimisation of Surgical Repair for Treating Insufficiency of the MItral Valve - Safety and Effectiveness Evaluation N/A
Recruiting NCT04818502 - Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation
Terminated NCT03285724 - Safety and Performance Study of the Harpoon Mitral Valve Repair System N/A
Recruiting NCT04195984 - Mi-thos® Transcatheter Mitral Valve Replacement Study N/A
Active, not recruiting NCT04281940 - Chordal Repair for Transcatheter Mitral Valve Repair (TMVr) N/A