EffecTAVI Registry

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age55-100
SponsorFederico II University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Ability to provide informed consent.

Disqualifiers

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.

Trial population

Patients with symptomatic severe AS candidate to TAVI, established by the multi-disciplinary Heart Team according to the current guidelines.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Transcatheter heart valve (THV) with CE approval

    Device

    TAVI trough femoral access or alternative routes

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: Patients with symptomatic severe AS undergoing TAVI.1 intervention

Trial outcomes

Primary outcomes

1

All cause mortality

All cause mortality

Time frame
30 days
2

All cause mortality

All cause mortality

Time frame
1 year

Secondary outcomes

1

Cardiovascular mortality

Cardiovascular mortality

Time frame
30 days
2

Cardiovascular mortality

Cardiovascular mortality

Time frame
1 year
3

Number of participants with neurological events

Neurological events

Time frame
30 days
4

Number of participants with neurological events

Neurological events

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.