Clinical trial NCT02974881: 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
Overall status: COMPLETED
Phase: NA
Conditions: Mitral Valve Regurgitation
Mitral Valve Insufficiency
Lead sponsor: HighLife SAS
Sponsor class: INDUSTRY
Collaborators: name: MedPass International
name: ICON plc
First posted: 2016-11-29
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Freedom of major adverse events
timeFrame: at 30 days post procedure
measure: Continued intended performance of the HighLife™ bioprosthesis
timeFrame: at 30 days post procedure
measure: Technical success
timeFrame: immediately after procedure
Secondary outcomes:
measure: Device Success (per MVARC definitions)
timeFrame: At 30 days, 6 months and 12 months post procedure
measure: Procedure Success
timeFrame: At 30 days, 6 months and 12 months post procedure
measure: Patient Success
timeFrame: At 30 days, 6 months and 12 months post procedure
measure: Hemodynamic Performance vs. Baseline
timeFrame: At 7 days, 30 days, at 6 months and 12 months and at 2, 3, 4 and 5 years
measure: Functional Improvement vs. Baseline
timeFrame: At 30 days, 6 months and 12 months
measure: Quality of Life Improvement vs. Baseline
timeFrame: At 6 months and 12 months
Other outcomes:
Locations:
city: Lille
country: France
facility: CHRU Lille
city: Massy
country: France
facility: Hôpital Privé Jacques Cartier
city: Nantes
country: France
facility: CHU Nantes
city: Paris
country: France
facility: Groupe Hospitalier Pitié-Salpétrière Institut de Cardiologie
city: Rennes
country: France
facility: CHU Rennes Pontchaillou
city: Toulouse
country: France
facility: CHU Toulouse Rangueil
city: Bonn
country: Germany
facility: Universitätsklinikum
city: Hamburg
country: Germany
facility: Universitäres Herzzentrum Hamburg GmbH (UHZ)
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
city: Munich
country: Germany
facility: Deutsches Herzzentrum München des Freistaates Bayern
Study officials:
affiliation: Groupe Hospitalier Pitié-Salpétrière Institut de Cardiologie
name: Jean-Philippe Collet, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.