Portuguese Registry With Meril Myval THV Series - MyPORTuVal Registry

ConditionsAortic Valve Stenosis TAVI(Transcatheter Aortic Valve Implantation)

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorPortuguese Association of Interventional Cardiology

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Patient has provided written informed consent as approved by the Ethics Committee (EC)

Patient is willing to undergo all registry procedures and follow-up requirements

Disqualifiers

Patients with hyper sensitivity or allergy to aspirin, heparin, clopidogrel, ticlopidine, cobalt, nickel, chromium, molybdenum or any contrast media.

Ongoing infective endocarditis or any similar infection.

Pregnant or lactating females.

Liver failure (Child-Pugh Class B or C)

Trial population

Patients with symptomatic severe native aortic valve stenosis who underwent TAVI using Myval THV series as assessed by Heart Team and Investigator.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Myval THV series
Device
Transcatheter Aortic Valve Implantation

Treatment groups

No treatment groups listed

Trial 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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Portuguese Association of Interventional Cardiology

Lead sponsor

Meril Life Sciences Pvt. Ltd.

Collaborator

Source ClinicalTrials.gov

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