Clinical Trial

Observational Study Relating to the Long-term Follow-up of Patients with Severe Aortic Stenosis Evaluated for Percutaneous Aortic Valve Replacement (TAVI).

Study acronym: ROARING-TAVI
Enrolling by Invitation
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Summary
All patients with severe aortic stenosis undergoing evaluation for TAVI are routinely subjected to a series of assessments: * Pre-implantation: thoraco-abdominal CT angiography, coronary angiography, echocardiography, clinical assessment, ECG, and laboratory tests. * Post-implantation: echocardiography, laboratory tests, ECG, assessment of any procedural complications, and a cardiology follow-up visit. This is an observational study, with the aim to monitor over time the population of patients who have undergone TAVI, identifying pre- and post-implant conditions that may negatively impact patient outcomes (both clinical factors and those directly related to the prosthetic implant). Through a 10-year follow-up, the study seeks to determine the incidence of prosthetic failure, as well as the incidence of prosthesis-related complications and major clinical endpoints.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-11-05; most recent amendment 2025-03-24.
Status change: Not Yet Recruiting → Enrolling by Invitation 2025-03-24
Trial Details
NCT Number NCT06679517
Lead Sponsor University Hospital of Ferrara
Conditions Severe Aortic Stenosis, TAVI(Transcatheter Aortic Valve Implantation)
Enrollment 600 participants
Start Date 2024-11-30
Primary Completion 2035-11-30 (estimated)
Study Completion 2035-11-30 (estimated)
Updated on ClinicalTrials.gov 2025-03-27