EffecTAVI Registry

Recruiting

• Conditions: TAVI; Aortic Stenosis; Transcatheter Aortic Valve Replacement
• Interventions: Device: Transcatheter heart valve (THV) with CE approval

• Registration Number: NCT05235555
• Lead Sponsor: Federico II University

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.

Study Timeline

• Study Start: 2015-09-01
• Primary Completion: 2021-09-09
• Study First Submitted: 2022-01-28
• Study First Submitted QC: 2022-02-08
• Study First Posted: 2022-02-11
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-23
• Study Completion: 2030-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with symptomatic severe AS undergoing TAVI.	Transcatheter heart valve (THV) with CE approval	-

Primary Outcome Measures

Name	Time	Method
All cause mortality	1 year	All cause mortality

Secondary Outcome Measures

Name	Time	Method
Number of participants with leaflet thickening	1 year	Hypo-attenuated leaflet thickening (HALT)
Cardiovascular mortality	1 year	Cardiovascular mortality
Vascular and access-related complications	1 year	Vascular and access-related complications
Number of participants with myocardial infarction	1 year	Myocardial infarction
Cardiac structural complications	1 year	Any cardiac structure occurring during the procedure involving the aortic annulus, left ventricle outflow tract, ventricular septum, left or right ventricle, left or right atrium, mitral valve apparatus, tricuspid valve apparatus, coronary sinus, and pericardial effusion.
Number of participants with leaflet reduced motion	1 year	Reduced leaflet motion (RLM)
Number of participants with bleeding events	1 year	Bleeding events
Number of participants with acute kidney injury	1 year	Acute kidney injury
Hospitalization or re-hospitalization	1 year	Any admission after the index hospitalization or study enrolment to an inpatient unit or hospital ward for ≥24 h, including an emergency department stay.
Number of participants with neurological events	1 year	Neurological events
Number of participants with new conduction disturbances and arrhythmias	1 year	New conduction disturbances and arrhythmias
Number of participants with bioprosthetic valve dysfunction	1 year	Bioprosthetic valve dysfunction
Number of participants with clinically significant valve thrombosis	1 year	Clinically significant valve thrombosis

Trial Locations

Locations (1)

Federico II University of Naples; 🇮🇹 Naples, Italy