Portuguese Registry With Meril Myval THV Series - MyPORTuVal Registry

Portuguese Association of Interventional Cardiology150 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Aortic Valve Stenosis TAVI(Transcatheter Aortic Valve Implantation)

Interventions

Myval THV seriesDEVICE

Transcatheter Aortic Valve Implantation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (6)

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

Outcomes

Primary Outcomes

Safety of Myval valve and TAVI procedure

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

Time frame: 30 days

Secondary Outcomes

Safety and Performance of Myval valve and TAVI procedure

1. All-cause mortality (cardiac and non-cardiac) 2. All stroke 3. Acute Kidney Injury (AKI) System-Stage 2, 3 and 4 4. Moderate or severe paravalvular leak 5. Conduction disturbances and Arrythmias 6. New permanent pacemaker implantation 7. Major vascular complications 8. Vascular and access related complications 9. Echocardiography measurements 10. Procedure-related assessments 11. New York Heart Association (NYHA) Functional Classification 12. Re-Hospitalization 13. Bleeding (Type 3 and 4) 14. Myocardial Infarction 15. Length of index hospital stay 16. Cardiac structural complications 17. Aortic bioprosthetic valve dysfunction 18. Bioprosthetic valve deterioration 19. Conversion to open surgery 20. Unplanned use of mechanical circulatory support 21. Implantation of multiple (\>1) transcatheter valves during the index hospitalization 22. Valve malposition 23. Technical success 24. Device success 25. Early safety

Time frame: 30 days and 12 Months

Central Contacts

Ana Domingues

CONTACT

+351217970685 ana.domingues@spc.pt

Joana D Silva, MD

CONTACT

+351217970685 joanadelgadosilva@gmail.com

Data from ClinicalTrials.gov

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