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NCT06818435 | NOT YET RECRUITING | Aortic Valve Stenosis

Portuguese Registry with Meril Myval THV Series - MyPORTuVal Registry
Sponsor:

Portuguese Association of Interventional Cardiology

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.

Condition or disease

Aortic Valve Stenosis

TAVI(Transcatheter Aortic Valve Implantation)

Intervention/treatment

Myval THV series

Study Type : OBSERVATIONAL
Estimated Enrollment : 150 participants
Official Title : Portuguese Registry with Meril Myval THV Series - MyPORTuVal Registry
Actual Study Start Date : 2025-05
Estimated Primary Completion Date : 2028-05
Estimated Study Completion Date : 2028-11

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Patient over the age of 18 years with symptomatic aortic stenosis (severe AS) who underwent TAVI using Myval THV series as assessed by Heart Team and Investigator.
  • 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.
Portuguese Registry with Meril Myval THV Series - MyPORTuVal Registry

Location Details

NCT06818435

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Portugal,

Local Health Unit of Western Lisbon E.P.E. - Santa Cruz Hospital

Carnaxide, Portugal, 2790-134

Not yet recruiting

Portugal,

Local Health Unit of Coimbra

Coimbra, Portugal, 3004-561

Not yet recruiting

Portugal,

Local Health Unit of São José E.P.E. - Santa Marta Hospital

Lisbon, Portugal, 1169-024

Not yet recruiting

Portugal,

Local Health Unit of Santa Maria, E.P.E. - Santa Maria Hospital

Lisbon, Portugal, 1649-035

Not yet recruiting

Portugal,

Local Unit of St. John E.P.E.

Porto, Portugal, 4200-319

Not yet recruiting

Portugal,

Local Health Unit Alentejo Central E.P.E. - Espírito Santo Hospital

Évora, Portugal, 7000-811