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| Name | Class |
|---|---|
| MedPass International | INDUSTRY |
| ICON plc | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter Mitral Valve Replacement | Device | Minimally invasive transcatheter mitral valve implantation using the HighLife™ TMVR system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom of major adverse events | including:
| 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:
| immediately after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Device Success (per MVARC definitions) | per MVARC definition | At 30 days, 6 months and 12 months post procedure |
| Procedure Success | per MVARC definition |
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Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Philippe Collet, MD | Groupe Hospitalier Pitié-Salpétrière Institut de Cardiologie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU Lille | Lille | 59000 | France | |||
| Hôpital Privé Jacques Cartier |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27640044 | Background | Lange R, Piazza N. HighLife transcatheter mitral valve replacement. EuroIntervention. 2016 Sep 18;12(Y):Y81-3. doi: 10.4244/EIJV12SYA22. No abstract available. | |
| 26184623 | 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. |
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| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| At 30 days, 6 months and 12 months post procedure |
| Patient Success | per MVARC definition | At 30 days, 6 months and 12 months post procedure |
| Hemodynamic Performance vs. Baseline | Echocardiographic evaluation | At 7 days, 30 days, at 6 months and 12 months and at 2, 3, 4 and 5 years |
| Functional Improvement vs. Baseline | New York Heart Association Class 6-Minute Walk Test | At 30 days, 6 months and 12 months |
| Quality of Life Improvement vs. Baseline | Kansas City Cardiomyopathy Questionnaire | At 6 months and 12 months |
| Massy |
| 91300 |
| France |
| CHU Nantes | Nantes | 44000 | France |
| Groupe Hospitalier Pitié-Salpétrière Institut de Cardiologie | Paris | 75013 | France |
| CHU Rennes Pontchaillou | Rennes | 35000 | France |
| CHU Toulouse Rangueil | Toulouse | France |
| Universitätsklinikum | Bonn | Germany |
| Universitäres Herzzentrum Hamburg GmbH (UHZ) | Hamburg | 20246 | Germany |
| Herzzentrum Leipzig | Leipzig | 04289 | Germany |
| Deutsches Herzzentrum München des Freistaates Bayern | Munich | 80636 | Germany |
| 28838477 | 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. |