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Registry for patients needing redo transcatheter heart valve implantation

Evaluation of Clinical Outcomes of Patients Undergoing a Redo-TAVI Procedure; a Multicenter Prospective Observational Registry

Observational Institut für Pharmakologie und Präventive Medizin · NCT05601453

This study is trying to see how well redo heart valve surgery works for patients whose previous heart valve implants have failed, looking at their recovery and overall health over the next year.

Quick facts

Study typeObservational
Enrollment250 (estimated)
Ages18 Years and up
SexAll
SponsorInstitut für Pharmakologie und Präventive Medizin Research network
Locations62 sites (Graz and 61 other locations)
Trial IDNCT05601453 on ClinicalTrials.gov

What this trial studies

This observational registry aims to evaluate the short- and long-term outcomes of patients undergoing redo transcatheter aortic valve implantation (redo-TAVI) due to failure of a previously implanted transcatheter heart valve (THV). It will collect data on procedural success, safety, and functional outcomes at 30 days and 1 year post-procedure. The study focuses on patients with structural valve deterioration and aims to provide insights into the efficacy of redo-TAVI in a multicenter setting. The findings will help establish best practices for managing patients requiring re-treatment for THV failure.

Who should consider this trial

Good fit: Ideal candidates include consenting adults aged 18 and older who have experienced failure of their first TAVI and are scheduled for a redo-TAVI procedure.

Not a fit: Patients with a life expectancy of less than 12 months or those without informed consent will not benefit from this study.

Why it matters

Potential benefit: If successful, this registry could improve treatment strategies and outcomes for patients requiring redo-TAVI procedures.

How similar studies have performed: While initial data on redo-TAVI is limited, this registry approach is novel and aims to fill the knowledge gap in this area.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Graz and 61 other locations

+12 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Structural Valve DeteriorationStructural Valve DegenerationSymptomatic Patients Who Have Had Transcatheter Heart Valve FailureProsthetic Valve MalfunctionProsthesis FailureTranscatheter Aortic Valve Implantationredo-TAVITHV-in-THV
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.