Safety and Effectiveness of Transcatheter Aortic Valve Implantation - EffecTAVI Registry

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 100
Healthy Volunteers: f
View:

• Patients with symptomatic severe AS or degenerated bioprosthetic aortic valve and suitable for TAVI according to Heart Team evaluation;

• Ability to provide informed consent.

Locations
Other Locations
Italy
Federico II University of Naples
RECRUITING
Naples
Contact Information
Primary
Giovanni Esposito, MD, PhD
espogiov@unina.it
+390817463075
Backup
Anna Franzone, MD, PhD
anna.franzone@unina.it
+390817464325
Time Frame
Start Date: 2015-09-01
Estimated Completion Date: 2030-01-01
Participants
Target number of participants: 1000
Treatments
Patients with symptomatic severe AS undergoing TAVI.
Sponsors
Leads: Federico II University

This content was sourced from clinicaltrials.gov