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Recruiting NCT06818435

Portuguese Registry With Meril Myval THV Series - MyPORTuVal Registry

— Observational Aortic Valve Stenosis TAVI(Transcatheter Aortic Valve Implantation)

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Myval THV series.
Who it may be relevant to
Registry conditions: Aortic Valve Stenosis, TAVI(Transcatheter Aortic Valve Implantation). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Portugal
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Myval THV series
    Transcatheter Aortic Valve Implantation

Primary outcome measures

  • Safety of Myval valve and TAVI procedure [Time frame: 30 days]
Secondary outcome measures (1)
  • Safety and Performance of Myval valve and TAVI procedure [Time frame: 30 days and 12 Months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Portugal · 6 centers
  • Unidade Local de Saúde do Lisboa Ocidental E.P.E. - Hospital Santa Cruz — Carnaxide
  • Unidade Local de Saúde de Coimbra — Coimbra
  • Unidade Local de Saúde Alentejo Central E.P.E. - Hospital Espírito Santo — Evora
  • Unidade Local de Saúde de São José E.P.E. - Hospital Santa Marta — Lisbon
  • Unidade Local de Saúde de Santa Maria, E.P.E. - Hospital de Santa Maria — Lisbon
  • Unidade Local de São João E.P.E. — Porto

Identifiers

NCT: NCT06818435 · MyPTVal-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗