HighLife™ Transcatheter Mitral Valve Replacement System Study

NCT02974881 | Completed DMC

• 1 other identifier: HL-2016-01
• Study Type: interventional
• Target: 5
• Locations: 2 countries
• Sites: 10

Brief Summary

Multicenter feasibility study of the HighLife™ TMVR system.

Conditions

Mitral Valve Regurgitation; Mitral Valve Insufficiency

Outcome Measures

Primary Outcomes (3)

• 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

  at 30 days post procedure

• 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)

  at 30 days post procedure

• 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

  immediately after procedure

Secondary Outcomes (6)

• Device Success (per MVARC definitions)

  At 30 days, 6 months and 12 months post procedure

• Procedure Success

  At 30 days, 6 months and 12 months post procedure

• Patient Success

  At 30 days, 6 months and 12 months post procedure

• Hemodynamic Performance vs. Baseline

  At 7 days, 30 days, at 6 months and 12 months and at 2, 3, 4 and 5 years

• Functional Improvement vs. Baseline

  At 30 days, 6 months and 12 months

Study Arms (1)

transcatheter mitral valve replacement

EXPERIMENTAL

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

Interventions

Transcatheter Mitral Valve Replacement DEVICE

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

transcatheter mitral valve replacement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HighLife SAS: lead
• MedPass International: collaborator
• ICON plc: collaborator

Study Sites (10)

CHRU Lille

Lille, 59000, France

Location

Hôpital Privé Jacques Cartier

Massy, 91300, France

Location

CHU Nantes

Nantes, 44000, France

Location

Groupe Hospitalier Pitié-Salpétrière Institut de Cardiologie

Paris, 75013, France

Location

CHU Rennes Pontchaillou

Rennes, 35000, France

Location

CHU Toulouse Rangueil

Toulouse, France

Location

Universitätsklinikum

Bonn, Germany

Location

Universitäres Herzzentrum Hamburg GmbH (UHZ)

Hamburg, 20246, Germany

Location

Herzzentrum Leipzig

Leipzig, 04289, Germany

Location

Deutsches Herzzentrum München des Freistaates Bayern

Munich, 80636, Germany

Location

Related Publications (3)

• Lange R, Piazza N. HighLife transcatheter mitral valve replacement. EuroIntervention. 2016 Sep 18;12(Y):Y81-3. doi: 10.4244/EIJV12SYA22. No abstract available.

  PMID: 27640044 BACKGROUND

• 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.

  PMID: 26184623 BACKGROUND

• 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.

  PMID: 28838477 BACKGROUND

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Jean-Philippe Collet, MD

  Groupe Hospitalier Pitié-Salpétrière Institut de Cardiologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2016
• First Posted: November 29, 2016
• Study Start: July 20, 2017
• Primary Completion: November 18, 2018
• Study Completion: January 16, 2024
• Last Updated: October 3, 2024

Record last verified: 2024-10

Locations

FR (6); DE (4)