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
- Italy1 site in 1 countryChoose a country to see its sites
- 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
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
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