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

Launched by UNIVERSITY HOSPITAL OF FERRARA · Nov 5, 2024

Keywords

ClinConnect Summary

This is an observational study at the University Hospital of Ferrara in Italy that follows people with severe aortic stenosis who are being considered for a transcatheter aortic valve implantation (TAVI). The goal is to learn, over up to 10 years, which pre- and post‑procedure factors influence how well patients do after TAVI and how the implanted valve performs. Researchers will collect data from routine care visits and follow up with patients by phone to capture long‑term outcomes.

Who can join: adults 18 and older with severe aortic stenosis who are candidates for TAVI and who have completed the standard pre‑TAVI tests (ECG and cardiology evaluation, echocardiogram, thoraco‑abdominal CT angiography, and coronary angiography). About 600 consecutive patients treated or evaluated for TAVI at Ferrara since 2016 are planned to be enrolled, with consent. The study does not change usual medical care. Participants will have pre‑TAVI assessments, the TAVI procedure details, and post‑TAVI follow‑ups, including echocardiograms, labs, and checkups, plus telephone follow‑ups at 1, 5, and 10 years to record events such as valve failure, death, stroke, heart attack, need for a pacemaker, endocarditis, hospitalizations, and other valve‑related issues. The main outcome they’re looking at is prosthesis failure at 10 years, defined as valve‑related death, the need for another valve procedure, or severe valve deterioration.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age \>18 years Signing of the consent form Diagnosis of severe aortic stenosis with an indication for TAVI Completion of the required TAVI pathway exams (ECG and cardiology consultation, echocardiogram, thoraco-abdominal aortic CT angiography, coronary angiography)
• Exclusion Criteria:
• • Lack of signed consent form Inability to complete follow-up