Clinical Trials Logo
  1. Home
  2. Mitral Valve Regurgitation
  3. NCT03908983

OPtimisation of Surgical Repair for Treating Insufficiency of the MItral Valve - Safety and Effectiveness Evaluation

Mitral Valve Regurgitation Clinical Trial

Official title:
OPtimisation of Surgical Repair for Treating Insufficiency of the MItral Valve - Safety and Effectiveness Evaluation (OPTIMISE II)

Clinical Trial Summary

KALIOS is indicated for the surgical treatment of mitral regurgitation by mitral valve repair.It is intended for mitral valve repair using conventional open heart or minimally invasive techniques. The KALIOS device is an adjustable annuloplasty ring, to be implanted by open surgery, having a hollow structure that comprises a flat rigid ring surrounding a deformable cage. The unique feature of KALIOS is that its annular shape and dimension can be finely adjusted percutaneously by an external actuator (three-balloon catheter) independently in the three areas corresponding to P1, P2 and P3 The primary objective of this clinical investigation is to assess the safety and effectiveness of KALIOS for the surgical treatment of Mitral Regurgitation with optional intra-operative and/or post-operative adjustment(s) The secondary objectives are to investigate the effects of KALIOS for the surgical treatment of Mitral Regurgitation on cardiac function and on patient functional status This clinical trial is prospective, non-randomized, single arm, multicentric & international. Up to 100 patients are expected to be enrolled to obtain 62 evaluable patients at one year,presenting with primary (degenerative) or secondary (functional) mitral valve regurgitation and who are candidate to a mitral valve repair.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03908983
Study type Interventional
Source Affluent Medical
Contact Michel Finance
Phone +33 6 18 39 93 93
Email michel.finance@affluentmedical.com
Status Recruiting
Phase N/A
Start date November 20, 2019
Completion date May 31, 2025
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 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
Completed NCT03104660 - Coronary and Structural Interventions Ulm - Transcatheter Mitral Valve Repair (CSI-Ulm-TMVR) N/A