Clinical trial NCT05235555: EffecTAVI Registry
Official title: Safety and Effectiveness of Transcatheter Aortic Valve Implantation - EffecTAVI Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Stenosis
Transcatheter Aortic Valve Replacement
TAVI
Keywords: Aortic Stenosis
Transcatheter Aortic Valve Replacement
TAVI
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2022-02-11
Enrollment: 1000
Sex: ALL
Minimum age (years): 55
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic severe AS candidate to TAVI, established by the multi-disciplinary Heart Team according to the current guidelines.

Brief 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.

Detailed 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.

Eligibility criteria: 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 outcomes:
measure: All cause mortality
timeFrame: 30 days
measure: All cause mortality
timeFrame: 1 year
Secondary outcomes:
measure: Cardiovascular mortality
timeFrame: 30 days
measure: Cardiovascular mortality
timeFrame: 1 year
measure: Number of participants with neurological events
timeFrame: 30 days
measure: Number of participants with neurological events
timeFrame: 1 year
measure: Number of participants with bleeding events
timeFrame: 30 days
measure: Number of participants with bleeding events
timeFrame: 1 year
measure: Vascular and access-related complications
timeFrame: 30 days
measure: Vascular and access-related complications
timeFrame: 1 year
measure: Number of participants with new conduction disturbances and arrhythmias
timeFrame: 30 days
measure: Number of participants with new conduction disturbances and arrhythmias
timeFrame: 1 year
measure: Number of participants with acute kidney injury
timeFrame: 30 days
measure: Number of participants with acute kidney injury
timeFrame: 1 year
measure: Number of participants with myocardial infarction
timeFrame: 30 days
measure: Number of participants with myocardial infarction
timeFrame: 1 year
measure: Hospitalization or re-hospitalization
timeFrame: 30 days
measure: Hospitalization or re-hospitalization
timeFrame: 1 year
measure: Cardiac structural complications
timeFrame: 30 days
measure: Cardiac structural complications
timeFrame: 1 year
measure: Number of participants with bioprosthetic valve dysfunction
timeFrame: 30 days
measure: Number of participants with bioprosthetic valve dysfunction
timeFrame: 1 year
measure: Number of participants with leaflet thickening
timeFrame: 30 days
measure: Number of participants with leaflet thickening
timeFrame: 1 year
measure: Number of participants with leaflet reduced motion
timeFrame: 30 days
measure: Number of participants with leaflet reduced motion
timeFrame: 1 year
measure: Number of participants with clinically significant valve thrombosis
timeFrame: 30 days
measure: Number of participants with clinically significant valve thrombosis
timeFrame: 1 year
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Federico II University of Naples
Study officials:
affiliation: Federico II University
name: Giovanni Esposito, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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