The ReTAVI Prospective Observational Registry
Recruiting
Observational Study
Structural Valve Deterioration
Structural Valve Degeneration
Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure
Prosthetic Valve Malfunction
Prosthesis Failure
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 250 (estimated)
- Sponsor
- Institut für Pharmakologie und Präventive Medizin · Research network
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
Consecutive patients fulfilling the following criteria:
1. Consenting adult patient (≥18 years)
2. Procedural success of the first TAVI
3. TAVI device failure of the index THV, irrespective of SVD severity
4. Intention to treat the patient with a redo-TAVI procedure (SAPIEN fam…
Contacts