Aortic Valve Stenosis, TAVI(Transcatheter Aortic Valve Implantation)
Conditions
Keywords
MyPORTuVal, TAVI, Portuguese TAVI Registry
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.
Interventions
DEVICEMyval THV series
Transcatheter Aortic Valve Implantation
Sponsors
Portuguese Association of Interventional Cardiology
Meril Life Sciences Pvt. Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Performance of Myval valve and TAVI procedure | 30 days and 12 Months | 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 |
Countries
Portugal
Contacts
CONTACTAna Domingues
CONTACTJoana D Silva, MD
STUDY_CHAIRRui Campante Teles, Prof. Dr.
Unidade Local de Saúde de Lisboa Ocidental, E.P.E. - Hospital de Santa Cruz
Outcome results
None listed