REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE (RESTORE)

Covidien

Status: Enrolling

Conditions: Aortic Stenosis

Treatments: Device: Edwards TAV; Device: Medtronic TAV

Study type: Observational

Funder types: Industry

Identifiers

NCT06777368

MDT23040EVR015

Details and patient eligibility

About

The purpose of this study is to generate clinical evidence on valve safety and performance in subjects treated by redo Transcatheter Aortic Valve Replacement (TAVR).

Full description

Primary Objectives:

• To determine the acute and long-term outcomes of redo TAVR for the treatment of BVF affecting TAVs
• To determine the factors which are associated with the acute and long-term outcomes of redo TAVR

Enrollment: 225 estimated patients

Sex: All

Ages: 18 to 105 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BVF of a TAV (either Medtronic or Edwards) requiring redo TAVR

Exclusion criteria

• BVF due solely to paravalvular regurgitation
• Active endocarditis
• Untreated acute valve thrombosis
• Life-expectancy less than 1-year
• Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable
• Participating in another study that may influence the outcome of this study

Trial design

225 participants in 1 patient group

Medtronic Transcatheter Aortic Valves (TAV) or Edwards Transcatheter Aortic Valves (TAV)

Description:

Subjects will receive either a Medtronic TAV or Edwards TAV

Treatment:

Device: Medtronic TAV

Device: Edwards TAV