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HighLife™ Transcatheter Mitral Valve Replacement System Study

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ClinicalTrials.gov Identifier: NCT02974881
Recruitment Status : Recruiting
First Posted : November 29, 2016
Last Update Posted : May 24, 2018
Sponsor:
Collaborators:
Meditrial Europe Ltd.
Action, France
Information provided by (Responsible Party):
HighLife SAS

November 11, 2016
November 29, 2016
May 24, 2018
July 20, 2017
July 2018   (Final data collection date for primary outcome measure)
  • 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
  • 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
Same as current
Complete list of historical versions of study NCT02974881 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
HighLife™ Transcatheter Mitral Valve Replacement System Study
HighLife™ Transcatheter Mitral Valve Replacement System for Severe Mitral Regurgitation in Patients at High Surgical Risk
Multicenter feasibility study of the HighLife™ TMVR system.

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.

Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Mitral Valve Regurgitation
  • Mitral Valve Insufficiency
Device: Transcatheter Mitral Valve Replacement
Minimally invasive transcatheter mitral valve implantation using the HighLife™ TMVR system
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
Same as current
December 2023
July 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Benoit Hallier +33 1 72 32 21 15 benoit@highlifemedical.com
France,   Germany
Italy
 
NCT02974881
HL-2016-01
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
HighLife SAS
HighLife SAS
  • Meditrial Europe Ltd.
  • Action, France
Study Director: Monica Tocchi, Dr. Meditrial Europe Ltd.
Study Director: Karine Brochard ACTION Coeur
Principal Investigator: Jean-Philippe Collet, MD Groupe Hospitalier Pitié-Salpétrière Institut de Cardiologie
HighLife SAS
May 2018

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