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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Commercial patients | That meet the criteria as outlined in the IFU, and who are scheduled to have the HighLife procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of Technical Success | 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:
| At exit from procedure room |
| Rate of Device Success | 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:
| 30 days |
| Primary Performance Endpoint | Rate of Total Mitral Regurgitation reduction to 1+ or less assessed by transthoracic echo (TTE), and as analyzed by an independent Core Lab | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Mortality | Where patient died during the procedure before exiting the procedure room | At exit from the procedure room |
| All-cause mortality | Patient death due to any cause |
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Inclusion Criteria: Participants must fulfill all following inclusion criteria in order to be included in the post market registry:
Participant is indicated for the HighLife TSMVR system per the current approved Instructions For Use (IFU)
Based on the assessment of the local multidisciplinary heart team, the participant is:
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:
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Per Instruction For Use (IFU): Adult patients suffering from symptomatic moderate-severe or severe MR who are unsuitable for surgical repair/replacement and transcatheter edge-to-edge repair, as deemed by a multi-disciplinary heart team.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vanessa Gallois | Contact | +33 6 68 77 34 77 | vgallois@highlifemed.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Ulm | Ulm | Ulm | 89081 | Germany |
This will still need to be confirmed and discussed internally.
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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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| 30 days, 6 months, 12 months, 1, 2, and 3 year |
| Reoperation | To include conversion to surgery, reintervention to surgery or non-surgical procedure | 30 days |
| Disabling stroke | Meeting the criteria of disabling versus non-disabling stroke, as defined per MVARC guidelines, to include if ischemic or hemorrhagic | 30 days, 6 months, 1, 2, 3 years |
| New onset conduction disturbance in the heart | This would be a heart conduction disturbance requiring a permanent pacemaker | 30 days |
| Heart Failure Hospitalization | This would be a heart failure hospitalization, defined per the MVARC guidelines. | 30 days, 6 and 12 months, 1, 2, 3 years |
| Freedom from left ventricular outflow tract obstruction (LVOTO) | Mean LVOT gradient ≥ 10 mmHg, as measured by transthoracic echo (TTE), and as analyzed by an independent Core Lab | 30 days |
| Freedom from paravalvular leak (PVL), > 1+ | This would be a leak around the HighLife valve, as assessed by transthoracic echo (TTE), and analyzed by an independent Core Lab | 30 days |
| Annualized rate of Heart Failure Hospitalization (HFH) | An analysis performed by the biostatistician, to evaluate how often a patient experienced HFH in a year. | 1, 2, 3 years |
| Total reduction of mitral regurgitation (MR) to 1+ or less | Measure by transthoracic echo (TTE), and as analyzed by an independent Core Lab | 30 days, 6 months, 1, 2, 3 years |
| Long term durability of the HighLife valve | 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). | 3 years |
| KCCQ score (mean) improvement | Mean improvement in the KCCQ Quality of Life Questionnaire (short form), comparing Baseline to 1 year | 1 year |
| Improvement in six minute walk test (6MWT) | Measuring the number of meters a patient can walk in 6 minutes, comparing Baseline to 1 year | 1 year |