Portuguese Registry With Meril Myval THV Series - MyPORTuVal Registry

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.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases TAVI(Transcatheter Aortic Valve Implantation) Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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)
Patient is currently participating in another clinical investigation where the primary endpoint has not been achieved.
Any condition, which in the investigator opinion, would preclude safe participation of the patient in the Registry.

Treatment and study plan

Myval THV Series

Device

Transcatheter Aortic Valve Implantation

Primary outcomes

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

Secondary outcomes

Safety and Performance of Myval valve and TAVI procedure

Time frame: 30 days and 12 Months
- 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ana Domingues

CONTACT

[email protected]

+351217970685

Joana D Silva, MD

CONTACT

[email protected]

+351217970685

Sponsors and collaborators

Lead sponsor

Portuguese Association of Interventional Cardiology

Other

Collaborators

Meril Life Sciences Pvt. Ltd.

Registry information

Acronym: MyPORTuVal

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2028
First posted: Feb 10, 2025
Registry last updated: Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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