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Trial record 1 of 3 for:    Highlife
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HighLife™ Transcatheter Mitral Valve Replacement System Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02974881
Recruitment Status : Active, not recruiting
First Posted : November 29, 2016
Last Update Posted : April 6, 2020
MedPass International
Information provided by (Responsible Party):
HighLife SAS

Tracking Information
First Submitted Date  ICMJE November 11, 2016
First Posted Date  ICMJE November 29, 2016
Last Update Posted Date April 6, 2020
Actual Study Start Date  ICMJE July 20, 2017
Actual Primary Completion Date November 18, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2016)
  • Freedom of major adverse events [ Time Frame: at 30 days post procedure ]
    • 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
  • 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)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2016)
  • Device Success (per MVARC definitions) [ Time Frame: At 30 days, 6 months and 12 months post procedure ]
    per MVARC definition
  • Procedure Success [ Time Frame: At 30 days, 6 months and 12 months post procedure ]
    per MVARC definition
  • Patient Success [ Time Frame: At 30 days, 6 months and 12 months post procedure ]
    per MVARC definition
  • 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
  • Functional Improvement vs. Baseline [ Time Frame: At 30 days, 6 months and 12 months ]
    New York Heart Association Class 6-Minute Walk Test
  • Quality of Life Improvement vs. Baseline [ Time Frame: At 6 months and 12 months ]
    Kansas City Cardiomyopathy Questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE HighLife™ Transcatheter Mitral Valve Replacement System Study
Official Title  ICMJE HighLife™ Transcatheter Mitral Valve Replacement System for Severe Mitral Regurgitation in Patients at High Surgical Risk
Brief Summary Multicenter feasibility study of the HighLife™ TMVR system.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Mitral Valve Regurgitation
  • Mitral Valve Insufficiency
Intervention  ICMJE Device: Transcatheter Mitral Valve Replacement
Minimally invasive transcatheter mitral valve implantation using the HighLife™ TMVR system
Study Arms  ICMJE 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).
Intervention: Device: Transcatheter Mitral Valve Replacement
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 8, 2019)
Original Estimated Enrollment  ICMJE
 (submitted: November 23, 2016)
Estimated Study Completion Date  ICMJE December 15, 2023
Actual Primary Completion Date November 18, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany
Removed Location Countries Italy
Administrative Information
NCT Number  ICMJE NCT02974881
Other Study ID Numbers  ICMJE HL-2016-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party HighLife SAS
Study Sponsor  ICMJE HighLife SAS
Collaborators  ICMJE MedPass International
Investigators  ICMJE
Principal Investigator: Jean-Philippe Collet, MD Groupe Hospitalier Pitié-Salpétrière Institut de Cardiologie
PRS Account HighLife SAS
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP