EffecTAVI Registry

NCT05235555 · tracked via the Priya Life Science Italy tracker

Sponsor

Federico II University

Phase

Observational

Started

2015-09-01

Last updated

2024-02-23

Condition(s) studied

Aortic StenosisTranscatheter Aortic Valve ReplacementTAVI

Investigational drug(s) / intervention(s)

Transcatheter heart valve (THV) with CE approval

Transcatheter heart valve (THV) with CE approval: TAVI trough femoral access or alternative routes

Study summary

Aortic stenosis (AS) is the most common valvular heart disease among elderly population, with a increasing prevalence due to population ageing. In developed countries, the prevalence of severe AS among ≥75 years is approximately 3.4%. The onset of symptoms is associated with a poor prognosis. Indeed, mortality increases once symptoms appears.

For several decades, surgical aortic valve replacement (SAVR) has been the standard of care for symptomatic AS. Transcatheter aortic valve implantation (TAVI) was introduced as alternative treatment in inoperable patients in 2002. In the last two decades TAVI has led to a paradigm shift in the treatment of severe AS, representing a less invasive alternative to surgery. TAVI has shown to be non-inferior or superior to SAVR in several large-scale randomized clinical trials (RCTs) across the full spectrum of surgical risks. The newly available evidence has led to an expansion of guideline recommendations for TAVI. Furthermore, newer generations of transcatheter heart valve (THV) design, better patient selection, and technical enhancements have driven improvement in safety and reduction of procedural complications over time.

This observational study aim to prospectively evaluate the safety and efficacy of the procedure and clinical outcomes in patients undergoing TAVI.

Eligibility

Sex

ALL

Min age

55 Years

Max age

100 Years

Healthy volunteers

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.

Primary outcome measure(s)

All cause mortality — 30 days
All cause mortality
All cause mortality — 1 year
All cause mortality

Trial sites (1)

Facility	City	Region	Status
Federico II University of Naples	Naples	Italy	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05235555 on ClinicalTrials.gov ↗ ← All trials in Italy