The ReTAVI Prospective Observational Registry

Institut für Pharmakologie und Präventive Medizin

Status: Enrolling

Conditions: Prosthetic Valve Malfunction; Structural Valve Degeneration; Prosthesis Failure; Structural Valve Deterioration; Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure

Treatments: Procedure: Elective redo transcatheter aortic valve implantation (redo-TAVI)

Study type: Observational

Funder types: NETWORK; Industry

Identifiers

NCT05601453

ReTAVI Registry

Details and patient eligibility

About

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.

Full description

Between 1.4 and 2.8% of all patients undergoing transcatheter heart valve (THV) implantation require a second THV implanted into the previously implanted THV because of clinically significant aortic regurgitation [1-3]. 90% of THV-in-THV implants were considered successful although the mortality in the redo-TAVI group was higher at similar STS risks as in those with a successful first implant.

Redo-TAVI may also be a promising treatment strategy in degenerated THVs, but there is insufficient knowledge which strategy and valve design may result in the best outcomes [4]. Evidence so far reported is based on case reports and small case series, but not on a prospective, multicenter documentation.

Currently, ~ 5% of THV are implanted in degenerated surgical bioprosthetic valves. With the expanded use of THV for treatment of lower risk patients with severe aortic stenosis (sAS), it is estimated that the number of patients requiring re-treatment for THV failure is likely to rise within the next years.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

150 participants in 1 patient group

redo-TAVI patients

Description:

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

Treatment:

Procedure: Elective redo transcatheter aortic valve implantation (redo-TAVI)