Portuguese Registry With Meril Myval THV Series - MyPORTuVal Registry (MyPORTuVal)

January 15, 2026 updated by: Portuguese Association of Interventional Cardiology
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Portugal
      • Carnaxide, Portugal, 2790-134
        • Recruiting
        • Unidade Local de Saúde do Lisboa Ocidental E.P.E. - Hospital Santa Cruz
        • Contact:
      • Coimbra, Portugal, 3004-561
      • Evora, Portugal, 7000-811
        • Recruiting
        • Unidade Local de Saúde Alentejo Central E.P.E. - Hospital Espírito Santo
        • Contact:
      • Lisbon, Portugal, 1649-035
        • Recruiting
        • Unidade Local de Saúde de Santa Maria, E.P.E. - Hospital de Santa Maria
        • Contact:
      • Lisbon, Portugal, 1169-024
        • Not yet recruiting
        • Unidade Local de Saúde de São José E.P.E. - Hospital Santa Marta
        • Contact:
      • Porto, Portugal, 4200-319
        • Not yet recruiting
        • Unidade Local de São João E.P.E.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of Myval valve and TAVI procedure
Time Frame: 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
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Performance of Myval valve and TAVI procedure
Time Frame: 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
30 days and 12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Portuguese Association of Interventional Cardiology

Collaborators

Meril Life Sciences Pvt. Ltd.

Investigators

  • Study Chair: Rui Campante Teles, Prof. Dr., Unidade Local de Saúde de Lisboa Ocidental, E.P.E. - Hospital de Santa Cruz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2025

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

February 5, 2025

First Submitted That Met QC Criteria

February 5, 2025

First Posted (Actual)

February 10, 2025

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MyPTVal-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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