EffecTAVI Registry
Recruiting now
Conditions studied: Aortic Stenosis, Transcatheter Aortic Valve Replacement, TAVI
In brief
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.
Key facts
- Study ID
- NCT05235555
- Run by
- Federico II University
- People needed
- 1000
- Starts
- 2015-09-01
- Expected to finish
- 2030-01-01
- Last updated by the study team
- 2024-02-23
Who can join
Age: 55 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with symptomatic severe AS or degenerated bioprosthetic aortic valve and suitable for TAVI according to Heart Team evaluation;
- Ability to provide informed consent.
You may not qualify if…
- Contraindications to TAVI: e.g. evidence of intracardiac mass, thrombus or vegetation, endocarditis;
- Poor adherence to scheduled follow-up;
- Unable to understand and follow study-related instructions.
Where it is running
- Federico II University of Naples — Naples, Italy (enrolling)
Full record on ClinicalTrials.gov
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