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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05235555
Other study ID # 231/18
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2015
Est. completion date January 1, 2030

Study information

Verified date February 2024
Source Federico II University
Contact Giovanni Esposito, MD, PhD
Phone +390817463075
Email espogiov@unina.it
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Device:
Transcatheter heart valve (THV) with CE approval
TAVI trough femoral access or alternative routes

Locations

Country Name City State
Italy Federico II University of Naples Naples

Sponsors (1)

Lead Sponsor Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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Outcome

Type Measure Description Time frame Safety issue
Primary All cause mortality All cause mortality 30 days
Primary All cause mortality All cause mortality 1 year
Secondary Cardiovascular mortality Cardiovascular mortality 30 days
Secondary Cardiovascular mortality Cardiovascular mortality 1 year
Secondary Number of participants with neurological events Neurological events 30 days
Secondary Number of participants with neurological events Neurological events 1 year
Secondary Number of participants with bleeding events Bleeding events 30 days
Secondary Number of participants with bleeding events Bleeding events 1 year
Secondary Vascular and access-related complications Vascular and access-related complications 30 days
Secondary Vascular and access-related complications Vascular and access-related complications 1 year
Secondary Number of participants with new conduction disturbances and arrhythmias New conduction disturbances and arrhythmias 30 days
Secondary Number of participants with new conduction disturbances and arrhythmias New conduction disturbances and arrhythmias 1 year
Secondary Number of participants with acute kidney injury Acute kidney injury 30 days
Secondary Number of participants with acute kidney injury Acute kidney injury 1 year
Secondary Number of participants with myocardial infarction Myocardial infarction 30 days
Secondary Number of participants with myocardial infarction Myocardial infarction 1 year
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Number of participants with bioprosthetic valve dysfunction Bioprosthetic valve dysfunction 30 days
Secondary Number of participants with bioprosthetic valve dysfunction Bioprosthetic valve dysfunction 1 year
Secondary Number of participants with leaflet thickening Hypo-attenuated leaflet thickening (HALT) 30 days
Secondary Number of participants with leaflet thickening Hypo-attenuated leaflet thickening (HALT) 1 year
Secondary Number of participants with leaflet reduced motion Reduced leaflet motion (RLM) 30 days
Secondary Number of participants with leaflet reduced motion Reduced leaflet motion (RLM) 1 year
Secondary Number of participants with clinically significant valve thrombosis Clinically significant valve thrombosis 30 days
Secondary Number of participants with clinically significant valve thrombosis Clinically significant valve thrombosis 1 year
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