HighLife™ Transcatheter Mitral Valve Replacement System Study
Study Details
Study Description
Brief Summary
Multicenter feasibility study of the HighLife™ TMVR system.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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). |
Device: Transcatheter Mitral Valve Replacement
Minimally invasive transcatheter mitral valve implantation using the HighLife™ TMVR system
|
Outcome Measures
Primary Outcome Measures
- Freedom of major adverse events [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 [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 [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
Secondary Outcome Measures
- Device Success (per MVARC definitions) [At 30 days, 6 months and 12 months post procedure]
per MVARC definition
- Procedure Success [At 30 days, 6 months and 12 months post procedure]
per MVARC definition
- Patient Success [At 30 days, 6 months and 12 months post procedure]
per MVARC definition
- Hemodynamic Performance vs. Baseline [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 [At 30 days, 6 months and 12 months]
New York Heart Association Class 6-Minute Walk Test
- Quality of Life Improvement vs. Baseline [At 6 months and 12 months]
Kansas City Cardiomyopathy Questionnaire
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHRU Lille | Lille | France | 59000 | |
| 2 | Hôpital Privé Jacques Cartier | Massy | France | 91300 | |
| 3 | CHU Nantes | Nantes | France | 44000 | |
| 4 | Groupe Hospitalier Pitié-Salpétrière Institut de Cardiologie | Paris | France | 75013 | |
| 5 | CHU Rennes Pontchaillou | Rennes | France | 35000 | |
| 6 | CHU Toulouse Rangueil | Toulouse | France | ||
| 7 | Universitätsklinikum | Bonn | Germany | ||
| 8 | Universitäres Herzzentrum Hamburg GmbH (UHZ) | Hamburg | Germany | 20246 | |
| 9 | Herzzentrum Leipzig | Leipzig | Germany | 04289 | |
| 10 | Deutsches Herzzentrum München des Freistaates Bayern | Munich | Germany | 80636 |
Sponsors and Collaborators
- HighLife SAS
- MedPass International
Investigators
- Principal Investigator: Jean-Philippe Collet, MD, Groupe Hospitalier Pitié-Salpétrière Institut de Cardiologie
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- Lange R, Piazza N. HighLife transcatheter mitral valve replacement. EuroIntervention. 2016 Sep 18;12(Y):Y81-3. doi: 10.4244/EIJV12SYA22. Review.
- Stone GW, Adams DH, Abraham WT, Kappetein AP, Généreux 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.
- HL-2016-01