Observational Study Relating to the Long-term Follow-up of Patients with Severe Aortic Stenosis Evaluated for Percutaneous Aortic Valve Replacement (TAVI).
Key facts
- Who runs it
- University Hospital of Ferrara
- Where
- Ferrara, ItalySee the site
- Trial code
- Status
- Enrolling by invitation
- People taking part
- 600 people, planned
- Started
- 30 Nov 2024
- Expected to end
- 30 Nov 2035
- Type of study
- Observational
- Treatments tested
- TAVI
- Record updated
- 27 March 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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)
Who cannot take part
- Lack of signed consent form Inability to complete follow-up
Where in Italy
- Azienda Ospedaliero Universitaria di FerraraFerrara, ItalyNo longer taking part
About the trial
What the trial wants to find out
All patients with severe aortic stenosis undergoing evaluation for TAVI are routinely subjected to a series of assessments:
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* 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.
The group in the trial
- Patients with aortic stenosis undergoing TAVI
Patients with a diagnosis of severe aortic stenosis candidates to TAVI procedures.
Treatment: TAVI
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Studio OsseRvaziOnAle RelatIvo Al Follow-up a LuNGo Termine Di Pazienti Con Stenosi Aortica Severa Valutati Per Sostituzione Valvolare Aortica Percutanea (TAVI).
- Record updated
- 27 March 2025