NCT06818435 Portuguese Registry With Meril Myval THV Series - MyPORTuVal Registry
| NCT ID | NCT06818435 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Portuguese Association of Interventional Cardiology |
| Condition | Aortic Valve Stenosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-05-13 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2025-05-13 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 condition, which in the investigator opinion, would preclude safe participation of the patient in the Registry.
Contact & Investigator
Rui Campante Teles, Prof. Dr.
STUDY CHAIR
Unidade Local de Saúde de Lisboa Ocidental, E.P.E. - Hospital de Santa Cruz
Frequently Asked Questions
Who can join the NCT06818435 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aortic Valve Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06818435 currently recruiting?
Yes, NCT06818435 is actively recruiting participants. Contact the research team at ana.domingues@spc.pt for enrollment information.
Where is the NCT06818435 trial being conducted?
This trial is being conducted at Carnaxide, Portugal, Coimbra, Portugal, Evora, Portugal, Lisbon, Portugal and 2 additional locations.
Who is sponsoring the NCT06818435 clinical trial?
NCT06818435 is sponsored by Portuguese Association of Interventional Cardiology. The principal investigator is Rui Campante Teles, Prof. Dr. at Unidade Local de Saúde de Lisboa Ocidental, E.P.E. - Hospital de Santa Cruz. The trial plans to enroll 150 participants.