Severe aortic stenosis Severe aortic stenosis
Conditions
Interventions
1 group (384 patients) will be treated with the Myval transcatheter heartvalve.
1 group (384 patients) will be treated with the Edwards Sapien or Medtronic
Evolut heartvalve.
For the nested registry
Sponsors
Meril Life Sciences
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: As per local Heart Team assessment, patient is eligible for TAVI and the patient is suitable for implantation with all three study devices.
Exclusion criteria
Exclusion criteria: Any condition, which in the Investigator*s opinion, would preclude safe participation of patient in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study parameters/outcome of the study: It is the composite of following (at 30 days) VARC-3 defined criteria: - All-cause mortality - All stroke - Bleeding (Type 3 and 4) - Acute kidney injury (stage 2, 3 and 4) - Major vascular complications - Moderate or severe prosthetic valve regurgitation - Conduction system disturbances resulting in a new permanent pacemaker implantationPrimary study parameters/outcome of the study: It is the composite of following (at 1 year) VARC-3 defined criteria:Freedom from all-cause mortalityFreedom from all strokeFreedom from hospitalization for procedure- or valve-related causes | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical efficacy endpoint is the composite of following [at 1-year] (VARC-3 defined criteria): - Freedom from all-cause mortality - Freedom from all stroke - Freedom from hospitalization for procedure- or valve-related causes - Freedom from SF-12 physical and mental score decline of > 2.5 points from baselineClinical efficacy endpoint is the composite of following [at 3-year, 5-year] (VARC-3 defined criteria): - Freedom from all-cause mortality - Freedom from all stroke - Freedom from hospitalization for procedure- or valve-related causes - Freedom from SF-12 physical and mental score decline of > 2.5 points from baseline 2- All-cause mortality (VARC-3 defined criteria) (till 10-year) 3- All stroke (VARC-3 defined criteria till 5-year 4. Acute Kidney Injury (AKI)( stage 2, 3 and 4) (VARC-3 defined criteria) ( till 1-year) 5. Bleeding (Type 3 and 4) (VARC-3 defined criteria) (till 5-year) 6. Moderate or severe prosthetic valve regurgitation (VARC-3 defined criteria) (10-year) 7. New permanent pacemaker implantation (VARC-3 defined criteria) (till 10-year) 8. Conduction disturbances and arrhythmias (VARC-3 defined criteria(till 5-year) 9. Technical success (VARC-3 defined criteria) [Time Frame: Post-procedure] 10 Device success (VARC-3 criteria) 11 Safety at 30 days (VARC-3 criteria) 12 Clinical efficacy at 30 days (VARC-2 criteria) 13. Valve related long-term clinical efficacy (VARC-3 defined criteria) (till 10 years) 14. Vascular and access related complications (VARC-3 defined criteria) (till 1-year) 15. Major vascular complications (VARC-3 defined criteria) (till 1-year) 16. Myocardial Infarction (VARC-3 defined criteria) (till 5-year) 17. Functional improvement from baseline as measured per - NYHA class - 6 minute walking test 18 - Echocardiographic parameters (till 10 years) 19- Bioprosthetic valve deterioration (VARC-3 defined criteria (5-year) 20. Patient-prosthesis mismatch (VARC-2 defined criteria) (till 1-ye | — |
Countries
Croatia, France, Germany, Greece, Hungary, Italy, Netherlands, New Zealand, Norway, Poland, Portugal, Slovenia, Spain, Sweden, Switzerland, United Kingdom
Contacts
Public ContactPHJ Schelfhout
Clinical Research Assistance
Outcome results
None listed