HighLife™ Transcatheter Mitral Valve Replacement System Study

Mitral Valve Insufficiency Clinical Trial

Official title:

HighLife™ Transcatheter Mitral Valve Replacement System for Severe Mitral Regurgitation in Patients at High Surgical Risk

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02974881
• Other study ID #: HL-2016-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 20, 2017
• Est. completion date: December 15, 2023

Study information

• Verified date: November 2023
• Source: HighLife SAS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Multicenter feasibility study of the HighLife™ TMVR system.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5
• Est. completion date: December 15, 2023
• Est. primary completion date: November 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mitral Valve Insufficiency
• Mitral Valve Regurgitation

Intervention

Device:
• Transcatheter Mitral Valve Replacement
Minimally invasive transcatheter mitral valve implantation using the HighLife™ TMVR system

Locations

Country	Name	City	State
France	CHRU Lille	Lille
France	Hôpital Privé Jacques Cartier	Massy
France	CHU Nantes	Nantes
France	Groupe Hospitalier Pitié-Salpétrière Institut de Cardiologie	Paris
France	CHU Rennes Pontchaillou	Rennes
France	CHU Toulouse Rangueil	Toulouse
Germany	Universitätsklinikum	Bonn
Germany	Universitäres Herzzentrum Hamburg GmbH (UHZ)	Hamburg
Germany	Herzzentrum Leipzig	Leipzig
Germany	Deutsches Herzzentrum München des Freistaates Bayern	Munich

Sponsors (3)

Lead Sponsor	Collaborator
HighLife SAS	ICON plc, MedPass International

Countries where clinical trial is conducted

France,  Germany, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Device Success (per MVARC definitions)	per MVARC definition	At 30 days, 6 months and 12 months post procedure
Secondary	Procedure Success	per MVARC definition	At 30 days, 6 months and 12 months post procedure
Secondary	Patient Success	per MVARC definition	At 30 days, 6 months and 12 months post procedure
Secondary	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
Secondary	Functional Improvement vs. Baseline	New York Heart Association Class 6-Minute Walk Test	At 30 days, 6 months and 12 months
Secondary	Quality of Life Improvement vs. Baseline	Kansas City Cardiomyopathy Questionnaire	At 6 months and 12 months