Clinical trial Recruiting at 1 site Observational Ages 55 to 100

Registry for patients undergoing Transcatheter Aortic Valve Replacement

Official title: Safety and Effectiveness of Transcatheter Aortic Valve Implantation - EffecTAVI Registry

Run by Federico II University · NCT05235555 · Data updated 2026-11-12

This study is tracking patients with severe aortic stenosis who are having a new heart valve procedure called TAVI to see how safe and effective it is for their health.

Quick facts

Study typeObservational
Ages55 Years to 100 Years
SexAll
Enrollment1000 (estimated)
SponsorFederico II University
Academic / other
Locations1 site (Naples)
StatusRecruiting
StartedSeptember 1, 2015
Main results expectedSeptember 9, 2021
Study endsJanuary 1, 2030
Registry record updatedFebruary 23, 2024
Trial IDNCT05235555 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients with symptomatic severe aortic stenosis who are suitable for TAVI as determined by a Heart Team evaluation.

Probably not a fit

Patients with contraindications to TAVI or those unable to adhere to follow-up may not benefit from this study.

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

What this trial studies

This observational registry aims to evaluate the safety and efficacy of Transcatheter Aortic Valve Implantation (TAVI) in patients with symptomatic severe aortic stenosis. It will collect clinical, procedural, and echocardiographic data to assess the clinical outcomes of the TAVI procedure. The study is conducted at the Federico II University in Naples and focuses on patients deemed suitable for TAVI by a multidisciplinary team. The findings will contribute to understanding the impact of TAVI on patient health and outcomes.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of TAVI's effectiveness and safety, potentially improving treatment options for patients with aortic stenosis.

How similar studies have gone: Previous studies have shown success with TAVI, establishing it as a viable alternative to surgical aortic valve replacement.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Patients with symptomatic severe AS or degenerated bioprosthetic aortic valve and suitable for TAVI according to Heart Team evaluation;
2. Ability to provide informed consent.

Exclusion Criteria:

1. Contraindications to TAVI: e.g. evidence of intracardiac mass, thrombus or vegetation, endocarditis;
2. Poor adherence to scheduled follow-up;
3. Unable to understand and follow study-related instructions.

Where it's running

  • Federico II University of Naples
    Naples, Italy
    Recruiting

Study contacts

  • Principal investigator: Giovanni Esposito, MD, PhD — Federico II University
  • Study coordinator: Giovanni Esposito, MD, PhD
  • Email: espogiov@unina.it
  • Phone: +390817463075

Similar studies

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

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.