Patients with severe aortic stenosis (sAS) treated with transcatheter aortic valve implantation (TAVI) (increasingly younger \& lower risk pts) are experiencing SVD of the index THV and thus developing an indication for a redo-TAVI procedure.
The evidence on redo-TAVI (where a transcatheter heart valve \[THV\] is implanted into another THV) is limited, with initial data showing acceptable safety as well efficacy in highly selected and limited populations.
Aim is to evaluate short- and long-term data on patients undergoing transcatheter redo-TAVI procedures with THVs for failure of a previously implanted THV and to determine VARC-3 defined efficacy and safety at 30 days and functional outcome at 1 year, 3 years and 5 years.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Consenting adult patient (≥18 years)
. Procedural success of the first TAVI
. TAVI device failure of the index THV, irrespective of SVD severity
. Intention to treat the patient with a redo-TAVI procedure (SAPIEN family THV)
. The Local Heart Team and the Case Review Board consider the patient suitable and indicated for elective redo-TAVI
. Patient is scheduled to undergo a 30 Day and 12 Months follow-up (both visits taking place in the hospital)
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy: VARC-3 defined device success at 30 days
Timeframe: 30 days
2
Technical success: Technical success (at exit from procedure room)
Timeframe: end of intervention
3
Safety: VARC-3 defined early safety at 30 days
Timeframe: 30 days
4
Procedural Outcomes (30 days)
Timeframe: 30 days
5
Durability of the second aortic THV (30 days)
Timeframe: 30 days
6
Durability of the second aortic THV (3 months)
Timeframe: 3 months
7
Durability of the second aortic THV (12 months)
Timeframe: 12 months
8
Durability of the second aortic THV (3 years)
Trial details
NCT IDNCT05601453
SponsorInstitut für Pharmakologie und Präventive Medizin