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Portuguese Registry with Meril Myval THV Series - MyPORTuVal Registry

P

Portuguese Association of Interventional Cardiology

Status

Not yet enrolling

Conditions

Aortic Valve Stenosis
TAVI(Transcatheter Aortic Valve Implantation)

Treatments

Device: Myval THV series

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT06818435
MyPTVal-1

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Patient over the age of 18 years with symptomatic aortic stenosis (severe AS) who underwent TAVI using Myval THV series as assessed by Heart Team and Investigator.
  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.

Trial contacts and locations

6

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Central trial contact

Ana Domingues; Rita Calé, MD

Data sourced from clinicaltrials.gov

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