RECRUITING

Valved Graft PMCF Study

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Conditions

Aortic Valve DiseaseAscending Aorta AbnormalityAortic DissectionAortic Root ReplacementAscending Aorta ReplacementValved GraftCAVGJVAVGJ

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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

Multicenter, global, prospective, non-randomized, interventional, post-market trial. All subjects enrolled will receive an Abbott Valved Graft device.

Official Title

Valved Graft Post-Market Clinical Follow-up Study

Quick Facts

Study Start:2021-07-13
Study Completion:2029-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04754217

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * cardiac surgery including the implant of a VAVGJ or CAVGJ for native or prosthetic valve replacement
  1. * anticoagulation therapy intolerant
  2. * active endocarditis
  3. * anatomical or medical, surgical, psychological or social contraindications

Contacts and Locations

Study Contact

Paolo Amato
CONTACT
+39 335 61 40 573
paolo.amato@abbott.com
Karine Miquel
CONTACT
+32 479 60 01 07
karine.miquel@abbott.com

Study Locations (Sites)

University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham, Alabama, 35294
United States
University of Michigan
Ann Arbor, Michigan, 48104
United States
Mission Health & Hospitals
Asheville, North Carolina, 28801
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: Abbott Medical Devices

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 Date2021-07-13
Study Completion Date2029-09

Study Record Updates

Study Start Date2021-07-13
Study Completion Date2029-09

Terms related to this study

Keywords Provided by Researchers

  • Aortic Root Replacement
  • Ascending Aorta Replacement
  • Valved Graft
  • CAVGJ
  • VAVGJ

Additional Relevant MeSH Terms

  • Aortic Valve Disease
  • Ascending Aorta Abnormality
  • Aortic Dissection