RECRUITING

REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE

Quick Facts

Study Start:2025-01
Study Completion:2033-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06777368

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.

Ages Eligible for Study:18 Years to 105 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * BVF of a TAV (either Medtronic or Edwards) requiring redo TAVR
  1. * BVF due solely to paravalvular regurgitation
  2. * Active endocarditis
  3. * Untreated acute valve thrombosis
  4. * Life-expectancy less than 1-year
  5. * Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable
  6. * Participating in another study that may influence the outcome of this study

Contacts and Locations

Study Contact

RESTORE Study Clinical Team
CONTACT
763 514 4000
RS.RESTORESTUDY@medtronic.com

Principal Investigator

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 Locations (Sites)

UPMC Pinnacle
Mechanicsburg, Pennsylvania, 17050
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01
Study Completion Date2033-07

Study Record Updates

Study Start Date2025-01
Study Completion Date2033-07

Terms related to this study

Additional Relevant MeSH Terms

  • Aortic Stenosis