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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Safety of Myval valve and TAVI procedure — 30 days Composite of:
* All-cause mortality
* All stroke
* Acute kidney injury (stage 2, 3 and 4)
* Bleeding (Type 3 and 4)
* Moderate or severe paravalvular leak
* Major vascular complications
* Conduction disturbances resulting in new permanent pacemaker implantation
Trial sites (6)
Facility
City
Region
Status
Unidade Local de Saúde do Lisboa Ocidental E.P.E. - Hospital Santa Cruz
Carnaxide
Portugal
Recruiting
Unidade Local de Saúde de Coimbra
Coimbra
Portugal
Recruiting
Unidade Local de Saúde Alentejo Central E.P.E. - Hospital Espírito Santo
Evora
Portugal
Recruiting
Unidade Local de Saúde de São José E.P.E. - Hospital Santa Marta
Lisbon
Portugal
Not Yet Recruiting
Unidade Local de Saúde de Santa Maria, E.P.E. - Hospital de Santa Maria
Lisbon
Portugal
Recruiting
Unidade Local de São João E.P.E.
Porto
Portugal
Not Yet Recruiting
More Portuguese Association of Interventional Cardiology trials in Portugal
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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