EffecTAVI Registry

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Aortic Stenosis, Transcatheter Aortic Valve Replacement, TAVI

Intervention / Treatment
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* Device: Transcatheter heart valve (THV) with CE approval


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with symptomatic severe AS or degenerated bioprosthetic aortic valve and suitable for TAVI according to Heart Team evaluation; Ability to provide informed consent. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with symptomatic severe AS undergoing TAVI.<br> | Device: Transcatheter heart valve (THV) with CE approval<br>* TAVI trough femoral access or alternative routes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality | All cause mortality | 30 days | 
| All cause mortality | All cause mortality | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular mortality | Cardiovascular mortality | 30 days | 
| Cardiovascular mortality | Cardiovascular mortality | 1 year | 
| Number of participants with neurological events | Neurological events | 30 days | 
| Number of participants with neurological events | Neurological events | 1 year | 
| Number of participants with bleeding events | Bleeding events | 30 days | 
| Number of participants with bleeding events | Bleeding events | 1 year | 
| Vascular and access-related complications | Vascular and access-related complications | 30 days | 
| Vascular and access-related complications | Vascular and access-related complications | 1 year | 
| Number of participants with new conduction disturbances and arrhythmias | New conduction disturbances and arrhythmias | 30 days | 
| Number of participants with new conduction disturbances and arrhythmias | New conduction disturbances and arrhythmias | 1 year | 
| Number of participants with acute kidney injury | Acute kidney injury | 30 days | 
| Number of participants with acute kidney injury | Acute kidney injury | 1 year | 
| Number of participants with myocardial infarction | Myocardial infarction | 30 days | 
| Number of participants with myocardial infarction | Myocardial infarction | 1 year | 
| Hospitalization or re-hospitalization | Any admission after the index hospitalization or study enrolment to an inpatient unit or hospital ward for ≥24 h, including an emergency department stay. | 30 days | 
| Hospitalization or re-hospitalization | Any admission after the index hospitalization or study enrolment to an inpatient unit or hospital ward for ≥24 h, including an emergency department stay. | 1 year | 
| Cardiac structural complications | 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. | 30 days | 
| Cardiac structural complications | 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. | 1 year | 
| Number of participants with bioprosthetic valve dysfunction | Bioprosthetic valve dysfunction | 30 days | 
| Number of participants with bioprosthetic valve dysfunction | Bioprosthetic valve dysfunction | 1 year | 
| Number of participants with leaflet thickening | Hypo-attenuated leaflet thickening (HALT) | 30 days | 
| Number of participants with leaflet thickening | Hypo-attenuated leaflet thickening (HALT) | 1 year | 
| Number of participants with leaflet reduced motion | Reduced leaflet motion (RLM) | 30 days | 
| Number of participants with leaflet reduced motion | Reduced leaflet motion (RLM) | 1 year | 
| Number of participants with clinically significant valve thrombosis | Clinically significant valve thrombosis | 30 days | 
| Number of participants with clinically significant valve thrombosis | Clinically significant valve thrombosis | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic Stenosis, Transcatheter Aortic Valve Replacement, TAVI