NCT05601453 The ReTAVI Prospective Observational Registry
| NCT ID | NCT05601453 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut für Pharmakologie und Präventive Medizin |
| Condition | Structural Valve Deterioration |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2023-09-05 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2023-09-05 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 family THV) 5. The Local Heart Team and the Case Review Board consider the patient suitable and indicated for elective redo-TAVI 6. Patient is scheduled to undergo a 30 Day and 12 Months follow-up (both visits taking place in the hospital) Exclusion Criteria: 1. Patients without signed informed consent / data protection statement (according to requirements of local IRB/IEC) 2. Life expectancy below 12 months 3. Patients with largely incomplete data with respect to the aims of the project 4. Pregnant women at the time of the redo-TAVI Note: For all patients included a defined core data set will be collected prospectively. All patients being in accordance with above stated inclusion and exclusion criteria and receiving a balloon-expandable transcatheter aortic valve will be included in the extended documentation.
Contact & Investigator
Giuseppe Tarantini, Prof.
PRINCIPAL INVESTIGATOR
University of Padua Medical School, Padua, Italy
Frequently Asked Questions
Who can join the NCT05601453 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Structural Valve Deterioration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05601453 currently recruiting?
Yes, NCT05601453 is actively recruiting participants. Contact the research team at claudia.lueske@ippmed.de for enrollment information.
Where is the NCT05601453 trial being conducted?
This trial is being conducted at Graz, Austria, Linz, Austria, Sankt Pölten, Austria, Vienna, Austria and 11 additional locations.
Who is sponsoring the NCT05601453 clinical trial?
NCT05601453 is sponsored by Institut für Pharmakologie und Präventive Medizin. The principal investigator is Giuseppe Tarantini, Prof. at University of Padua Medical School, Padua, Italy. The trial plans to enroll 250 participants.