Mitral Regurgitation
Conditions
Brief summary
Post-market registry for post-market surveillance, as part of the post-market plan, for the HighLife transcatheter, transseptal, mitral valve replacement system in a real world commercial setting.
Interventions
None listed
Sponsors
HighLife SAS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants must fulfill all following inclusion criteria in order to be included in the post market registry: 1. Participant is indicated for the HighLife TSMVR system per the current approved Instructions For Use (IFU) * Participant (≥ 18 years age) with severe or moderately severe mitral valve regurgitation (MR) due to primary (i.e. degenerative) and/or secondary (i.e. functional MR. * Left Ventricular Ejection Fraction (LVEF) ≥ 30% * Left ventricular end-diastolic dimension (LVEDD) ≤ 70 mm 2. Based on the assessment of the local multidisciplinary heart team, the participant is: 1. unsuitable for heart surgery (mitral valve repair or replacement) 2. unsuitable for treatment with transcatheter edge-to-edge repair (complex TEER anatomy) 3. eligible to receive the HighLife TSMVR system per the current approved Instructions For Use (IFU) and as assessed by the local heart team
Exclusion criteria
Participants will be excluded from the post market registry as per the current approved Instructions For Use (IFU) if any of the following criteria is met: 1. Significantly calcified mitral valves; 2. Severe mitral annular calcification 3. Narrow femoral arteries that don't allow the passage of 18F sheaths; 4. More than 80 cm between the aortic valve and the femoral access; 5. Allergies to TSMV or SAI components (bovine tissue, Nitinol, polyester, polyethylene, PTFE); 6. Intolerance to anticoagulation/antiplatelet regimens or procedural anticoagulation; 7. Active bacterial endocarditis or other active infections; 8. Allergies to contrast media; 9. Previous implanted aortic valve prosthesis; 10. Evidence of intracardiac mass, thrombus, or vegetation. 11. Participant enrolled in another clinical study that may impact the follow-up or results of this study. 12. Participant has other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, may limit the patient's ability to participate in the clinical study or to comply with follow-up requirements. 13. Tricuspid valve disease requiring intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Technical Success | At exit from procedure room | To measure the rate of subjects that meet the definition of Technical success defined as an alive participant at exit from procedure room, with all of the following: * Successful vascular access, delivery and retrieval of the HighLife delivery systems * Deployment and correct positioning of the HighLife 28mm bio-prosthesis * Freedom from additional emergency surgery or re-intervention related to the device or access procedure, that occurred (was initiated) during the procedure |
| Rate of Device Success | 30 days | To measure the rate of subjects that meet the definition of Device safety, defined as the freedom of major adverse events at 30 days, as follows: * All-cause mortality * Myocardial infarction * Major/disabling stroke * Life-threatening bleeding (MVARC scale) * Major access and vascular complications * Stage 2 or 3 acute kidney injury (includes dialysis) * Any mitral valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention * Severe hypotension, heart failure or respiratory failure requiring intravenous vasopressors 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 for ≥ 48 hours, or prolonged intubation for ≥ 48 hours |
| Primary Performance Endpoint | 30 days | Rate of Total Mitral Regurgitation reduction to 1+ or less assessed by transthoracic echo (TTE), and as analyzed by an independent Core Lab |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Mortality | At exit from the procedure room | Where patient died during the procedure before exiting the procedure room |
| All-cause mortality | 30 days, 6 months, 12 months, 1, 2, and 3 year | Patient death due to any cause |
| Reoperation | 30 days | To include conversion to surgery, reintervention to surgery or non-surgical procedure |
| Disabling stroke | 30 days, 6 months, 1, 2, 3 years | Meeting the criteria of disabling versus non-disabling stroke, as defined per MVARC guidelines, to include if ischemic or hemorrhagic |
| New onset conduction disturbance in the heart | 30 days | This would be a heart conduction disturbance requiring a permanent pacemaker |
| Heart Failure Hospitalization | 30 days, 6 and 12 months, 1, 2, 3 years | This would be a heart failure hospitalization, defined per the MVARC guidelines. |
| Freedom from left ventricular outflow tract obstruction (LVOTO) | 30 days | Mean LVOT gradient ≥ 10 mmHg, as measured by transthoracic echo (TTE), and as analyzed by an independent Core Lab |
| Freedom from paravalvular leak (PVL), > 1+ | 30 days | This would be a leak around the HighLife valve, as assessed by transthoracic echo (TTE), and analyzed by an independent Core Lab |
| Annualized rate of Heart Failure Hospitalization (HFH) | 1, 2, 3 years | An analysis performed by the biostatistician, to evaluate how often a patient experienced HFH in a year. |
| Total reduction of mitral regurgitation (MR) to 1+ or less | 30 days, 6 months, 1, 2, 3 years | Measure by transthoracic echo (TTE), and as analyzed by an independent Core Lab |
| Long term durability of the HighLife valve | 3 years | That the original HighLife device remains implanted, free from structural valve dysfunction (e.g. residual MR ≥2+ in the presence of morphological deterioration (e.g., torn, flail, or frozen leaflet, calcification, fracture, migration or embolization, device detachment), as assessed by transthoracic echo (TTE) and analyzed by an independent Core Lab, or as adjudicated by a Clinical Events Committee (CEC). |
| KCCQ score (mean) improvement | 1 year | Mean improvement in the KCCQ Quality of Life Questionnaire (short form), comparing Baseline to 1 year |
| Improvement in six minute walk test (6MWT) | 1 year | Measuring the number of meters a patient can walk in 6 minutes, comparing Baseline to 1 year |
Countries
Germany
Contacts
CONTACTVanessa Gallois
Outcome results
None listed