The ReTAVI Prospective Observational Registry

Launched by INSTITUT FÜR PHARMAKOLOGIE UND PRÄVENTIVE MEDIZIN · Oct 28, 2022

Keywords

ClinConnect Summary

The ReTAVI Prospective Observational Registry is a clinical trial studying patients who have experienced problems with their previously implanted heart valves. Specifically, it focuses on patients with severe aortic stenosis who need a second procedure called redo-TAVI to replace a failed transcatheter heart valve (THV). This trial aims to gather information about the safety and effectiveness of redo-TAVI procedures, looking at patients’ outcomes after 30 days and one year post-surgery.

To participate in this trial, patients must be at least 18 years old, have had a successful first TAVI procedure, and require a redo-TAVI due to valve failure. They also need to be scheduled for follow-up visits at the hospital after the procedure. The trial is currently looking for participants, and all data collected will help improve the understanding of redo-TAVI for future patients. If you or a loved one is considering this option, this trial could provide valuable insights into the procedure's safety and outcomes.

Gender

ALL

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.