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Completed

NCT Number: NCT02974881

HighLife™ Transcatheter Mitral Valve Replacement System Study

Multicenter feasibility study of the HighLife™ TMVR system.

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Key information

Conditions

Mitral Valve Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU Lille, Lille, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcatheter Mitral Valve Replacement

Device

Minimally invasive transcatheter mitral valve implantation using the HighLife™ TMVR system

Primary outcomes

  1. 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

  2. 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)

  3. 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

Secondary outcomes

  1. Device Success (per MVARC definitions)

    Time frame: At 30 days, 6 months and 12 months post procedure

    per MVARC definition

  2. Procedure Success

    Time frame: At 30 days, 6 months and 12 months post procedure

    per MVARC definition

  3. Patient Success

    Time frame: At 30 days, 6 months and 12 months post procedure

    per MVARC definition

  4. 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

  5. Functional Improvement vs. Baseline

    Time frame: At 30 days, 6 months and 12 months

    New York Heart Association Class 6-Minute Walk Test

  6. Quality of Life Improvement vs. Baseline

    Time frame: At 6 months and 12 months

    Kansas City Cardiomyopathy Questionnaire

Sponsors and collaborators

Lead sponsor

HighLife SAS

Industry

Collaborators

  • ICON plc
  • MedPass International

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2024
First posted
Nov 29, 2016
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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