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HighLife™ Transcatheter Mitral Valve Replacement System Study

Primary Purpose

Mitral Valve Regurgitation, Mitral Valve Insufficiency

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Transcatheter Mitral Valve Replacement
Sponsored by
HighLife SAS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mitral Valve Regurgitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHRU Lille
  • Hôpital Privé Jacques Cartier
  • CHU Nantes
  • Groupe Hospitalier Pitié-Salpétrière Institut de Cardiologie
  • CHU Rennes Pontchaillou
  • CHU Toulouse Rangueil
  • Universitätsklinikum
  • Universitäres Herzzentrum Hamburg GmbH (UHZ)
  • Herzzentrum Leipzig
  • Deutsches Herzzentrum München des Freistaates Bayern

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

transcatheter mitral valve replacement

Arm Description

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).

Outcomes

Primary Outcome Measures

Freedom of major adverse events
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
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
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 Outcome Measures

Device Success (per MVARC definitions)
per MVARC definition
Procedure Success
per MVARC definition
Patient Success
per MVARC definition
Hemodynamic Performance vs. Baseline
Echocardiographic evaluation
Functional Improvement vs. Baseline
New York Heart Association Class 6-Minute Walk Test
Quality of Life Improvement vs. Baseline
Kansas City Cardiomyopathy Questionnaire

Full Information

First Posted
November 11, 2016
Last Updated
September 20, 2023
Sponsor
HighLife SAS
Collaborators
MedPass International
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1. Study Identification

Unique Protocol Identification Number
NCT02974881
Brief Title
HighLife™ Transcatheter Mitral Valve Replacement System Study
Official Title
HighLife™ Transcatheter Mitral Valve Replacement System for Severe Mitral Regurgitation in Patients at High Surgical Risk
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 20, 2017 (Actual)
Primary Completion Date
November 18, 2018 (Actual)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HighLife SAS
Collaborators
MedPass International

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Regurgitation, Mitral Valve Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
transcatheter mitral valve replacement
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Transcatheter Mitral Valve Replacement
Intervention Description
Minimally invasive transcatheter mitral valve implantation using the HighLife™ TMVR system
Primary Outcome Measure Information:
Title
Freedom of major adverse events
Description
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
Time Frame
at 30 days post procedure
Title
Continued intended performance of the HighLife™ bioprosthesis
Description
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)
Time Frame
at 30 days post procedure
Title
Technical success
Description
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
Time Frame
immediately after procedure
Secondary Outcome Measure Information:
Title
Device Success (per MVARC definitions)
Description
per MVARC definition
Time Frame
At 30 days, 6 months and 12 months post procedure
Title
Procedure Success
Description
per MVARC definition
Time Frame
At 30 days, 6 months and 12 months post procedure
Title
Patient Success
Description
per MVARC definition
Time Frame
At 30 days, 6 months and 12 months post procedure
Title
Hemodynamic Performance vs. Baseline
Description
Echocardiographic evaluation
Time Frame
At 7 days, 30 days, at 6 months and 12 months and at 2, 3, 4 and 5 years
Title
Functional Improvement vs. Baseline
Description
New York Heart Association Class 6-Minute Walk Test
Time Frame
At 30 days, 6 months and 12 months
Title
Quality of Life Improvement vs. Baseline
Description
Kansas City Cardiomyopathy Questionnaire
Time Frame
At 6 months and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Philippe Collet, MD
Organizational Affiliation
Groupe Hospitalier Pitié-Salpétrière Institut de Cardiologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU Lille
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Hôpital Privé Jacques Cartier
City
Massy
ZIP/Postal Code
91300
Country
France
Facility Name
CHU Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Groupe Hospitalier Pitié-Salpétrière Institut de Cardiologie
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
CHU Rennes Pontchaillou
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
CHU Toulouse Rangueil
City
Toulouse
Country
France
Facility Name
Universitätsklinikum
City
Bonn
Country
Germany
Facility Name
Universitäres Herzzentrum Hamburg GmbH (UHZ)
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Herzzentrum Leipzig
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
Deutsches Herzzentrum München des Freistaates Bayern
City
Munich
ZIP/Postal Code
80636
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
27640044
Citation
Lange R, Piazza N. HighLife transcatheter mitral valve replacement. EuroIntervention. 2016 Sep 18;12(Y):Y81-3. doi: 10.4244/EIJV12SYA22. No abstract available.
Results Reference
background
PubMed Identifier
26184623
Citation
Stone GW, Adams DH, Abraham WT, Kappetein AP, Genereux P, Vranckx P, Mehran R, Kuck KH, Leon MB, Piazza N, Head SJ, Filippatos G, Vahanian AS; Mitral Valve Academic Research Consortium (MVARC). Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 2: Endpoint Definitions: A Consensus Document From the Mitral Valve Academic Research Consortium. J Am Coll Cardiol. 2015 Jul 21;66(3):308-321. doi: 10.1016/j.jacc.2015.05.049.
Results Reference
background
PubMed Identifier
28838477
Citation
Barbanti M, Piazza N, Mangiafico S, Buithieu J, Bleiziffer S, Ronsivalle G, Scandura S, Giuffrida A, Popolo Rubbio A, Mazzamuto M, Sgroi C, Lange R, Tamburino C. Transcatheter Mitral Valve Implantation Using the HighLife System. JACC Cardiovasc Interv. 2017 Aug 28;10(16):1662-1670. doi: 10.1016/j.jcin.2017.06.046.
Results Reference
background

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HighLife™ Transcatheter Mitral Valve Replacement System Study

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