Portuguese Registry With Meril Myval THV Series - MyPORTuVal Registry
A prospective, single-arm, multi-centre registry to evaluate the safety and performance of Myval THV series using Transcatheter Aortic Valve Implantation (TAVI) procedure in patients with symptomatic severe native aortic valve stenosis.
| Condition(s) | Aortic Valve Stenosis, TAVI(Transcatheter Aortic Valve Implantation) |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | A prospective, single-arm, multi-centre registry to evaluate the safety and performance of Myval THV series using Transcatheter Aortic Valve Implantation (TAVI) procedure in patients with symptomatic severe native aortic valve stenosis. |
| Who can participate | Inclusion Criteria: 1. Patient over the age of 18 years with symptomatic aortic stenosis (severe AS), intended to perform TAVI procedure using Myval THV series as assessed by Heart Team. 2. Patient has provided written informed consent as approved by the Ethics Committee (EC) 3. Patient is willing to undergo all registry procedures and follow-up requirements Exclusion Criteria: 1. Patients with hyper sensitivity or allergy to aspirin, heparin, clopidogrel, ticlopidine, cobalt, nickel, chromium, molybdenum or any contrast media. 2. Ongoing infective endocarditis or any similar infection. 3. Pregnant or lactating females. 4. Liver failure (Child-Pugh Class B or C) 5. Patient is currently participating in another clinical investigation where the primary endpoint has not been achieved. 6. Any |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Portuguese Association of Interventional Cardiology |
| Locations | Carnaxide, Portugal; Coimbra, Portugal; Evora, Portugal; Lisbon, Portugal; Lisbon, Portugal; Porto, Portugal |
| Start date | 2025-05-13 |
| NCT ID | NCT06818435 |
| Official listing | https://clinicaltrials.gov/study/NCT06818435 |