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

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: Aortic Valve Stenosis; TAVI(Transcatheter Aortic Valve Implantation)
• Intervention / Treatment: Device: Myval THV series

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Ana Domingues; Phone Number: +351217970685; Email: ana.domingues@spc.pt
• Study Contact Backup: Name: Joana D Silva, MD; Phone Number: +351217970685; Email: joanadelgadosilva@gmail.com

Study Locations

• Portugal
  • Carnaxide, Portugal, 2790-134
    • Recruiting
    • Unidade Local de Saúde do Lisboa Ocidental E.P.E. - Hospital Santa Cruz
    • Contact: Sílvio Leal, MD; Phone Number: +351210431000; Email: silvionleal@gmail.com
  • Coimbra, Portugal, 3004-561
    • Recruiting
    • Unidade Local de Saude de Coimbra
    • Contact: Joana D Silva, Prof. Dr.; Email: joanadelgadosilva@gmail.com
  • Evora, Portugal, 7000-811
    • Recruiting
    • Unidade Local de Saúde Alentejo Central E.P.E. - Hospital Espírito Santo
    • Contact: Lino Patrício, Prof. Dr.; Phone Number: +351 266 740 100; Email: linopatricio@gmail.com
  • Lisbon, Portugal, 1649-035
    • Recruiting
    • Unidade Local de Saude de Santa Maria, E.P.E. - Hospital de Santa Maria
    • Contact: Pedro C Ferreira, MD; Email: pcarrilhoferreira@gmail.com
  • Lisbon, Portugal, 1169-024
    • Not yet recruiting
    • Unidade Local de Saúde de São José E.P.E. - Hospital Santa Marta
    • Contact: Duarte Cacela, MD; Phone Number: +351 21 359 4000; Email: dcacela@hotmail.com
  • Porto, Portugal, 4200-319
    • Not yet recruiting
    • Unidade Local de São João E.P.E.
    • Contact: Domingos Magalhães; Phone Number: +351 225 512 100; Email: dmmagalhaes_3@hotmail.com

Participation Criteria

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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Performance of Myval valve and TAVI procedure	All-cause mortality (cardiac and non-cardiac); All stroke; Acute Kidney Injury (AKI) System-Stage 2, 3 and 4; Moderate or severe paravalvular leak; Conduction disturbances and Arrythmias; New permanent pacemaker implantation; Major vascular complications; Vascular and access related complications; Echocardiography measurements; Procedure-related assessments; New York Heart Association (NYHA) Functional Classification; Re-Hospitalization; Bleeding (Type 3 and 4); Myocardial Infarction; Length of index hospital stay; Cardiac structural complications; Aortic bioprosthetic valve dysfunction; Bioprosthetic valve deterioration; Conversion to open surgery; Unplanned use of mechanical circulatory support; Implantation of multiple (>1) transcatheter valves during the index hospitalization; Valve malposition; Technical success; Device success; Early safety	30 days and 12 Months

Collaborators and Investigators

• 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

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: TAVI; MyPORTuVal; Portuguese TAVI Registry
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• 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