REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE

Description

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).

Conditions

Aortic Stenosis

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Study Overview

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Study Details

Study overview

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).

REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE

REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE

Condition
Aortic Stenosis
Intervention / Treatment

-

Contacts and Locations

Mechanicsburg

UPMC Pinnacle, Mechanicsburg, Pennsylvania, United States, 17050

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to 105 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Medtronic Cardiovascular,

Gregory Fontana, MD, STUDY_CHAIR, Los Robles Regional Medical Center

Guilherme Attizzani, MD, PRINCIPAL_INVESTIGATOR, UH, Cleveland Medical Center

Basel Ramlawi, PRINCIPAL_INVESTIGATOR, Lankenau Heart Institute

Study Record Dates

2033-07