Mitral Valve Insufficiency, Mitral Valve Regurgitation
Conditions
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.
Interventions
Minimally invasive transcatheter mitral valve implantation using the HighLife™ TMVR system
Sponsors
MedPass International
ICON plc
HighLife SAS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Procedure Success | At 30 days, 6 months and 12 months post procedure | per MVARC definition |
| Quality of Life Improvement vs. Baseline | At 6 months and 12 months | Kansas City Cardiomyopathy Questionnaire |
| 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 |
| Patient Success | At 30 days, 6 months and 12 months post procedure | per MVARC definition |
| Functional Improvement vs. Baseline | At 30 days, 6 months and 12 months | New York Heart Association Class 6-Minute Walk Test |
| Device Success (per MVARC definitions) | At 30 days, 6 months and 12 months post procedure | per MVARC definition |
Countries
France, Germany
Outcome results
None listed