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Active, not yet recruiting

REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE

NCT No.: NCT06777368

Study Type: OBSERVATIONAL

Phase:

Region: California - Northern

Acronym: RESTORE

Official Title

REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE

Purpose

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).

Detailed Description

Sex

Male & Female

Age Limit

Eligibility Criteria

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

Keywords and/or Specific Medical Conditions

  • Aortic Valve Disease,
  • Cardiovascular Diseases,
  • Heart Diseases,
  • Heart Valve Diseases,
  • Stenosis,
  • Ventricular Outflow Obstruction,
  • Aortic Valve,
  • Cardiology

Sponsors

  • Medtronic Cardiovascular

KP Clinical Facility

Clinical Area

  • Cardiology

Principal Investigator

Femi Philip  

Contact Information

 - CTP Digital Solutions
- CTP-DigitalSolutions@kp.org
- All Kaiser Permanente Northern California Medical Centers

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