Aortic Valve StenosisMyPORTuValNCT06818435
Portuguese Registry With Meril Myval THV Series - MyPORTuVal Registry
An observational study of Aortic Valve Stenosis and TAVI(Transcatheter Aortic Valve Implantation), run by Portuguese Association of Interventional Cardiology at 6 sites in Portugal.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, TAVI(Transcatheter Aortic Valve Implantation)
- What is being tested?
- Myval THV series
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 6 sitesPortugal
- Study dates
- 13 May 2025to Nov 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with symptomatic severe native aortic valve stenosis who underwent TAVI using Myval THV series as assessed by Heart Team and Investigator.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Portugal6 sites, 6 recruiting
- Recruiting
Unidade Local de Saúde do Lisboa Ocidental E.P.E. - Hospital Santa Cruz
Carnaxide, 2790-134
Sílvio Leal, MD, +351210431000, silvionleal@gmail.com
- Recruiting
Unidade Local de Saúde de Coimbra
Coimbra, 3004-561
Joana D Silva, Prof. Dr., joanadelgadosilva@gmail.com
- Recruiting
Unidade Local de Saúde Alentejo Central E.P.E. - Hospital Espírito Santo
Evora, 7000-811
Lino Patrício, Prof. Dr., +351 266 740 100, linopatricio@gmail.com
- Not yet recruiting
Unidade Local de Saúde de São José E.P.E. - Hospital Santa Marta
Lisbon, 1169-024
Duarte Cacela, MD, +351 21 359 4000, dcacela@hotmail.com
- Recruiting
Unidade Local de Saúde de Santa Maria, E.P.E. - Hospital de Santa Maria
Lisbon, 1649-035
Pedro C Ferreira, MD, pcarrilhoferreira@gmail.com
- Not yet recruiting
Unidade Local de São João E.P.E.
Porto, 4200-319
Domingos Magalhães, +351 225 512 100, dmmagalhaes_3@hotmail.com
About this study
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.
- Being tested
- Myval THV series
- Keywords
- MyPORTuVal, TAVI, Portuguese TAVI Registry
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myval THV seriesDevice
Transcatheter Aortic Valve Implantation
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (1)
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
Measured: 30 days and 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start13 May 2025
- Primary completionMay 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Portuguese Association of Interventional Cardiology
- Sponsor type
- University, hospital or other
- Collaborators
- Meril Life Sciences Pvt. Ltd.
- Responsible party
- Sponsor
- Investigators
- Rui Campante Teles, Prof. Dr., Study chair, Unidade Local de Saúde de Lisboa Ocidental, E.P.E. - Hospital de Santa Cruz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818435
- Sponsor's protocol ID
- MyPTVal-1
- Acronym
- MyPORTuVal
- Status last verified
- Feb 2025
- First submitted
- 5 Feb 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No