HighLife™ Transcatheter Mitral Valve Replacement System Study

October 1, 2024 updated by: HighLife SAS

HighLife™ Transcatheter Mitral Valve Replacement System for Severe Mitral Regurgitation in Patients at High Surgical Risk

Multicenter feasibility study of the HighLife™ TMVR system.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an exploratory clinical study designed to evaluate the feasibility, safety and performance of the Highlife TMVR System in a population of patients with severe symptomatic mitral regurgitation, who are not suitable for surgical or approved percutaneous treatments according to the judgement of the Heart Team. The data gathered in this study will allow to evaluate the feasibility of mitral replacement using the HighLife™ TMVR system and characterize the safety and performance profile of the HighLife™ TMVR System.

All patients will be followed periodically up to 12 months after the intervention and long term safety and performance will be collected annually up to 5 years.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59000
        • Chru Lille
      • Massy, France, 91300
        • Hôpital Privé Jacques Cartier
      • Nantes, France, 44000
        • CHU Nantes
      • Paris, France, 75013
        • Groupe Hospitalier Pitié-Salpétrière Institut de Cardiologie
      • Rennes, France, 35000
        • Chu Rennes Pontchaillou
      • Toulouse, France
        • CHU TOULOUSE Rangueil
  • Germany
      • Bonn, Germany
        • Universitätsklinikum
      • Hamburg, Germany, 20246
        • Universitäres Herzzentrum Hamburg GmbH (UHZ)
      • Leipzig, Germany, 04289
        • Herzzentrum Leipzig
      • Munich, Germany, 80636
        • Deutsches Herzzentrum München des Freistaates Bayern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Severe mitral regurgitation
  • New York Heart Association (NYHA) Functional Class II, III or ambulatory IV.
  • Patient is under maximally tolerated GDMT (incl. CRT) for at least 3 months
  • Multidisciplinary Heart Team consensus that the patient is inoperable or at high-risk for surgical repair/replacement due to significant co-morbid conditions
  • Multidisciplinary Heart Team consensus that the patient is not a suitable candidate for other approved percutaneous repair therapy due to anatomical or medical conditions
  • Patient meets the anatomical criteria for HighLife valve sizing as determined by CT and TEE

Main Exclusion Criteria:

  • Mitral stenosis
  • Rheumatic valve disease
  • Severe calcifications of the mitral annulus and/or mitral leaflets
  • Prior surgical or interventional treatment of the mitral valve
  • Unsuitable anatomy for the transapical access
  • Unsuitable anatomy of the aorta and ilio-femoral vessels for the transfemoral access
  • Untreated clinically significant coronary artery disease requiring revascularization
  • LVEF < 30%
  • LVEDD > 70mm
  • Echocardiographic evidence of intracardiac mass, thrombus or vegetation
  • Hypertrophic Obstructive Cardiomyopathy (HOCM)
  • Any surgical or interventional procedure (including PCI) done in the past 30 days prior to procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: transcatheter mitral valve replacement
HighLife TMVR System is a novel and innovative approach developed as an alternative treatment for severe MR when medical treatment is maximal and surgical interventions not possible or at high risk. The HighLife TMVR system is composed of a Transcatheter Mitral Valve (TMV), a sub-annular implant (SAI), and their delivery systems and loading tools. The HighLife Valve is a 31 mm mitral bioprosthesis made of a self-expanding Nitinol frame covered with polyester graft and supporting bovine pericardium leaflets. The bioprosthesis is used in conjunction with the Sub-Annular Implant (SAI).
Device: Transcatheter Mitral Valve Replacement
Minimally invasive transcatheter mitral valve implantation using the HighLife™ TMVR system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom of major adverse events
Time Frame: at 30 days post procedure

including:

  • All-cause mortality
  • Myocardial infarction or coronary ischemia requiring PCI or CABG
  • Major stroke
  • Life-threatening bleeding (MVARC scale)
  • Major access and vascular complications
  • Stage 2 or 3 acute kidney injury (includes dialysis)
  • Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention
  • Severe hypotension, heart failure or respiratory failure requiring intravenous pressors or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices, or prolonged intubation for ≥ 48H
at 30 days post procedure
Continued intended performance of the HighLife™ bioprosthesis
Time Frame: at 30 days post procedure
defined as the reduction of mitral regurgitation (MR) to either optimal (0+ to trace) or acceptable (reduced by at least 1 grade from baseline with no more than 2+ MR) without significant mitral stenosis (post-procedure EOA ≥ 1.5 cm2 with a transmitral gradient < 5mmHg) and with no greater than mild (1+) paravalvular MR (and without associated hemolysis)
at 30 days post procedure
Technical success
Time Frame: immediately after procedure

defined as alive patient at exit from procedure room, with all of the following:

  • Successful access, delivery and retrieval of the HighLife delivery systems
  • Deployment and correct positioning of the HighLife bioprosthesis
  • Freedom of additional emergency surgery or re-intervention related to the device or access procedure
immediately after procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device Success (per MVARC definitions)
Time Frame: At 30 days, 6 months and 12 months post procedure
per MVARC definition
At 30 days, 6 months and 12 months post procedure
Procedure Success
Time Frame: At 30 days, 6 months and 12 months post procedure
per MVARC definition
At 30 days, 6 months and 12 months post procedure
Patient Success
Time Frame: At 30 days, 6 months and 12 months post procedure
per MVARC definition
At 30 days, 6 months and 12 months post procedure
Hemodynamic Performance vs. Baseline
Time Frame: At 7 days, 30 days, at 6 months and 12 months and at 2, 3, 4 and 5 years
Echocardiographic evaluation
At 7 days, 30 days, at 6 months and 12 months and at 2, 3, 4 and 5 years
Functional Improvement vs. Baseline
Time Frame: At 30 days, 6 months and 12 months
New York Heart Association Class 6-Minute Walk Test
At 30 days, 6 months and 12 months
Quality of Life Improvement vs. Baseline
Time Frame: At 6 months and 12 months
Kansas City Cardiomyopathy Questionnaire
At 6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HighLife SAS

Collaborators

MedPass International
ICON plc

Investigators

  • Principal Investigator: Jean-Philippe Collet, MD, Groupe Hospitalier Pitié-Salpétrière Institut de Cardiologie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2017

Primary Completion (Actual)

November 18, 2018

Study Completion (Actual)

January 16, 2024

Study Registration Dates

First Submitted

November 11, 2016

First Submitted That Met QC Criteria

November 23, 2016

First Posted (Estimated)

November 29, 2016

Study Record Updates

Last Update Posted (Actual)

October 3, 2024

Last Update Submitted That Met QC Criteria

October 1, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HL-2016-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe