MedDataX Logo

Portuguese Registry With Meril Myval THV Series - MyPORTuVal Registry

NCT ID: NCT06818435

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-13

Study Completion Date

2028-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

MYVAL Transcatheter Heart Valve System - Prospective German Multicenter Registry

NCT06804148

Aortic Valve Stenosis
RECRUITING

Myval Global Study of Myval™ THV Series Implanted in Patients With Native Severe Aortic Valve Stenosis.

NCT04703699

Aortic Valve Stenosis
RECRUITING

Myval TransAXillary Transcatheter Aortic Valve Replacement Multicenter Clinical Registry

NCT06493994

Aortic Valve Stenosis
RECRUITING

Tunisian Registry of Trans Catheter Aortic Valve Implantation

NCT06503965

Tunisian Patients Already Implanted With a TAVI
RECRUITING

Surgical vs Transcatheter Aortic Valve Replacement in Young Patients

NCT06861361

Symptomatic Severe Aortic Stenosis
RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aortic Valve Stenosis TAVI(Transcatheter Aortic Valve Implantation)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Myval THV series

Transcatheter Aortic Valve Implantation

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Meril Life Sciences Pvt. Ltd.

INDUSTRY

Sponsor Role collaborator

Portuguese Association of Interventional Cardiology

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rui Campante Teles, Prof. Dr.

Role: STUDY_CHAIR

Unidade Local de Saúde de Lisboa Ocidental, E.P.E. - Hospital de Santa Cruz

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Unidade Local de Saúde do Lisboa Ocidental E.P.E. - Hospital Santa Cruz

Carnaxide, , Portugal

Site Status RECRUITING

Unidade Local de Saúde de Coimbra

Coimbra, , Portugal

Site Status RECRUITING

Unidade Local de Saúde Alentejo Central E.P.E. - Hospital Espírito Santo

Evora, , Portugal

Site Status RECRUITING

Unidade Local de Saúde de São José E.P.E. - Hospital Santa Marta

Lisbon, , Portugal

Site Status NOT_YET_RECRUITING

Unidade Local de Saúde de Santa Maria, E.P.E. - Hospital de Santa Maria

Lisbon, , Portugal

Site Status RECRUITING

Unidade Local de São João E.P.E.

Porto, , Portugal

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Portugal

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ana Domingues

Role: CONTACT

[email protected]
+351217970685

Joana D Silva, MD

Role: CONTACT

[email protected]
+351217970685

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sílvio Leal, MD

Role: primary

[email protected]
+351210431000

Joana D Silva, Prof. Dr.

Role: primary

[email protected]

Lino Patrício, Prof. Dr.

Role: primary

[email protected]
+351 266 740 100

Duarte Cacela, MD

Role: primary

[email protected]
+351 21 359 4000

Pedro C Ferreira, MD

Role: primary

[email protected]

Domingos Magalhães

Role: primary

[email protected]
+351 225 512 100

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MyPTVal-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI
NCT07343674 NOT_YET_RECRUITING
Observational Study to Collect Data of Patient Which Recieving a TAVI in TAVI Procedure
NCT07215143 NOT_YET_RECRUITING
LANDMARK Trial: a Randomised Controlled Trial of Myval THV
NCT04275726 RECRUITING NA
Valvular Heart Disease Registry
NCT03488732 RECRUITING
SwissTAVI Registry
NCT01368250 RECRUITING
Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI
NCT02221921 UNKNOWN NA
Perioperative Hemodynamic and Microcirculatory Physiological Study During TAVI
NCT06154642 COMPLETED
Long-term Prognosis and Valve Durability of TAVR
NCT06379386 RECRUITING
VARC-TAVI VALVE IMPLANTATION)
NCT06177392 NOT_YET_RECRUITING NA
ChAracterization of Patients and Treatment OUtcomes in Severe Tricuspid Regurgitation
NCT06838611 RECRUITING
TAVR for Aortic Valve Disease
NCT05439863 RECRUITING
Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry
NCT03836521 RECRUITING
TAVIS Registry - Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease
NCT05536310 NOT_YET_RECRUITING
Safety and Efficacy Continued Access Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and High Risk Subjects Who Need Aortic Valve Replacement
NCT01531374 COMPLETED NA
Women's INternational Transcatheter Aortic Valve Implantation Registry
NCT01819181 COMPLETED
The Bicuspid Aortic Stenosis Following Transcatheter Aortic Valve Replacement Registry
NCT02394184 COMPLETED
CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry
NCT04688190 RECRUITING
Assessment of Right Ventricular Function in Patients With Severe Mitral Stenosis Before and After Balloon Mitral Valvuloplasty
NCT06067815 UNKNOWN
The Prospective Segeberg TAVI Registry
NCT03192774 RECRUITING
Transcatheter Aortic Valve Replacement for Pure Severe Aortic Valve Regurgitation
NCT06381271 RECRUITING
Siegel™ Transcatheter Aortic Valve Replacement System (TAVR) Early Feasibility Study
NCT06680427 ACTIVE_NOT_RECRUITING NA
Transcatheter Aortic Valve Implantation Versus Standard Surgical Aortic Valve Replacement
NCT05261204 ENROLLING_BY_INVITATION
Transcatheter Aortic Valve Implantation Registry at the National Research Center for Cardiac Surgery, Nur-Sultan, Kazakhstan
NCT06874465 RECRUITING NA
Assessment of Arrhythmias in Patients Undergoing Transcatheter Aortic Valve Implantation Using a Small Insertable Cardiac Monitoring Device
NCT02559011 COMPLETED
Registry to Evaluate the Impact of a Valve Coordinator on Aortic Stenosis / TAVI Outcome - (German Pilot)
NCT03570190 COMPLETED