EffecTAVI Registry

Aortic Stenosis Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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.

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

EffectTAVI is an observational, monocentric registry promoted by Department of Advanced Biomedical Sciences of University of Naples Federico II.

The aim is to collect clinical, procedural, echocardiographic data and to evaluate the clinical outcomes of TAVI procedure.

Study population: consecutive patients with symptomatic severe AS candidate to TAVI, established by the multi-disciplinary Heart Team according to current guidelines recommendations.

Severe AS will be defined according to the following echocardiographic criteria:

• Aortic valve area: < 1 cm2

• Indexed aortic valve area: < 0,6 cm2/m2

• Mean aortic valve gradient: ≥ 40 mmHg

• Peak aortic jet velocity: ≥ 4,0 m/sec

TAVI can be performed using several arterial access: transfemoral, transapical, trans-subclavian and trans-aortic.

Written informed consent will be obtained for all patients for participation in this registry.

After hospital discharge, clinical follow-up will be performed at 30-day, 6 months and 1-year after TAVI. All adverse events were systematically collected and classified according to the definitions of the Valve Academic Research Consortium (VARC)-3 criteria.

Clinical, procedural and follow-up data will be anonymously entered in a web-based database RedCap (https://www.redcap.unina.it/redcap/). Patients will be entered with a pseudonym generated by the data collection system.

The pseudonym does not allow the identification of the patient and, therefore, meets the European criteria for the acquisition of data online.

The access to the online database is allowed through the use of a personal password, provided to the Primary Investigator and to the Co-Investigators involved in the study.

Data analysis will be performed by the investigators of the Department of Advanced Biomedical Sciences.

The extensive case studies that investigators expect to collect will be useful to establish clinical, procedural and follow-up data in short, medium and long term of patients with severe aortic stenosis undergoing TAVI. ;

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• TAVI
• Transcatheter Aortic Valve Replacement

• NCT number: NCT05235555
• Study type: Observational [Patient Registry]
• Source: Federico II University
• Contact: Giovanni Esposito, MD, PhD
• Phone: +390817463075
• Email: espogiov@unina.it
• Status: Recruiting
• Start date: September 1, 2015
• Completion date: January 1, 2030