Recruiting

Redo-TAVI

Sponsor:

Institut für Pharmakologie und Präventive Medizin

Code:

NCT05601453

Conditions

Structural Valve Deterioration

Structural Valve Degeneration

Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure

Prosthetic Valve Malfunction

Prosthesis Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Elective redo transcatheter aortic valve implantation (redo-TAVI)

Study Details

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.

Conditions

Structural Valve Deterioration

Structural Valve Degeneration

Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure

Prosthetic Valve Malfunction

Prosthesis Failure

Study ID

NCT05601453

Start date

Sep 5, 2023

Status verified date

Aug, 2025

Completion date

Dec, 2031

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Arms

redo-TAVI patients

Patients with severe aortic stenosis (sAS) treated with TAVI developing SVD and thus an indication for redo-TAVI procedure

Interventions

Elective redo transcatheter aortic valve implantation (redo-TAVI)

Elective redo-TAVI procedure with the intention to treat the patient with a SAPIEN family valve implantation (currently the only registered medical devices for redo-TAVI use)

Primary outcome measure

  • Efficacy: VARC-3 defined device success at 30 days [ Time Frame: 30 days ]
  • Technical success: Technical success (at exit from procedure room) [ Time Frame: end of intervention ]
  • Safety: VARC-3 defined early safety at 30 days [ Time Frame: 30 days ]
  • Procedural Outcomes (30 days) [ Time Frame: 30 days ]
  • Durability of the second aortic THV (30 days) [ Time Frame: 30 days ]
  • Durability of the second aortic THV (3 months) [ Time Frame: 3 months ]
  • Durability of the second aortic THV (12 months) [ Time Frame: 12 months ]
  • Durability of the second aortic THV (3 years) [ Time Frame: 3 years ]
  • Durability of the second aortic THV (5 years) [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Claudia Lüske, PhD

044718503324claudia.lueske@ippmed.de

Daniel Greinert

044718503328daniel.greinert@ippmed.de

Locations

McGill University Health Centre

Recruiting

Montreal, Canada, H4A 3J1

Institut Universitaire de Cardiologie et de Pneumologie

Recruiting

Québec, Canada, QC G1V 4G5

St. Paul's Hospital, Vancouver

Recruiting

Vancouver, Canada, BC V6Z 1Y6

More Information

Sponsor

Institut für Pharmakologie und Präventive Medizin

Last update posted

Aug 20, 2025

Last verified

Aug, 2025

Keywords

  • Transcatheter Aortic Valve Implantation (TAVI)
  • Structural Valve Deterioration
  • redo-TAVI
  • THV-in-THV
  • TAV-in-TAV
  • TAVR-in-TAVR
  • Redo-TAVR
  • Revalve

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Institut für Pharmakologie und Präventive Medizin on 2025-08-20.