Portuguese Myval transcatheter aortic valve registry

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-arm, multicenter registry enrolling adults with symptomatic severe native aortic valve stenosis treated with the Myval transcatheter heart valve (THV) via TAVI. Patients are screened and selected by a local Heart Team, provide informed consent, and undergo the TAVI procedure using the Myval THV series. Clinical and safety outcomes are collected at the participating Portuguese centers and during scheduled follow-up visits. The registry is observational and aims to document real-world performance and adverse events associated with the device.

Why it matters

Who can join: the full rules

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.

Where it's running

• Unidade Local de Saúde do Lisboa Ocidental E.P.E. - Hospital Santa Cruz
  Carnaxide, Portugal Recruiting
• Unidade Local de Saúde de Coimbra
  Coimbra, Portugal Recruiting
• Unidade Local de Saúde Alentejo Central E.P.E. - Hospital Espírito Santo
  Evora, Portugal Recruiting
• Unidade Local de Saúde de Santa Maria, E.P.E. - Hospital de Santa Maria
  Lisbon, Portugal Recruiting
• Unidade Local de Saúde de São José E.P.E. - Hospital Santa Marta
  Lisbon, Portugal Not yet recruiting
• Unidade Local de São João E.P.E.
  Porto, Portugal Not yet recruiting

Study contacts

• Study coordinator: Ana Domingues
• Email: ana.domingues@spc.pt
• Phone: +351217970685

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Intravenous iron infusion after transcatheter aortic valve implantation for people with iron deficiency

  This trial will test whether an intravenous iron infusion after TAVI helps people aged 65 and older with severe aortic stenosis and iron deficiency feel better and walk farther.

  Recruiting Phase 4 Erasmus Medical Center · Rotterdam, South Holland · NCT07370688

• Transcatheter Aortic Valve Replacement Registry for Outcomes and Quality Monitoring

  This registry collects information from hospitals about patients undergoing TAVR to see how care and outcomes compare to guidelines and nationwide data.

  Recruiting American College of Cardiology · Washington D.C., District of Columbia · NCT07908355

• Detecting cardiac amyloidosis in people with severe aortic valve narrowing

  This study tests non-invasively whether imaging tests can find heart amyloidosis in patients with severe aortic stenosis who are being evaluated for valve replacement.

  Recruiting University Hospital Tuebingen · Tübingen · NCT07752732

• Vericiguat to slow calcific aortic valve narrowing

  This trial tests whether vericiguat can slow the progression of mild-to-moderate calcific aortic valve stenosis compared with placebo.

  Recruiting Phase 2 West China Hospital · Chengdu, Sichuan · NCT07715279

• CHATEAU Registry: Real-world outcomes after TAVR

  This registry collects real-world data from adults who had TAVR between 2021 and 2025 to see how they do over time and how valve performance holds up.

  Recruiting Eunpyeong St. Mary's Hospital · Seoul · NCT07709858

• Feasibility and safety of using a tele-operated robot to guide TAVR with TAVIPILOT software

  This study tests whether a tele-operated robotic system can help place a transcatheter heart valve during TAVR in patients aged 65 and older.

  Recruiting at 2 sites Caranx Medical · Sydney, New South Wales and 1 other locations · NCT07664163

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.