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ENROLLING BY INVITATION
NCT06679517

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

Sponsor: University Hospital of Ferrara

View on ClinicalTrials.gov

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.

Official title: Studio OsseRvaziOnAle RelatIvo Al Follow-up a LuNGo Termine Di Pazienti Con Stenosi Aortica Severa Valutati Per Sostituzione Valvolare Aortica Percutanea (TAVI).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

600

Start Date

2024-11-30

Completion Date

2035-11-30

Last Updated

2025-03-27

Healthy Volunteers

No

Interventions

PROCEDURE

TAVI

Clinical follow-up up to 10 years of patients undergoing TAVI

Locations (1)

Azienda Ospedaliero Universitaria di Ferrara

Ferrara, Italy