COMPLETED

This Study Will Evaluate the Safety and Potential Complications of Dual ProGlide vs Single ProGlide and Angioseal for Common Femoral Arteriotomy Closure Following Transcatheter Aortic Valve Replacement

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

This prospective, randomized, parallel, single-center, open-label, non-inferiority study will evaluate the safety and potential complications of dual ProGlide vs single ProGlide and Angioseal for common femoral arteriotomy closure following Transcatheter Aortic Valve Replacement.

Official Title

Randomized Trial Comparing Dual Perclose Vs Single Angioseal And Perclose in Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement

Quick Facts

Study Start:2025-02-12
Study Completion:2025-10-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06983938

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. * Age ≥ 18 years old
  2. * Planned to undergo transcatheter aortic valve replacement via femoral access
  3. * Able to provide written informed consent prior to study participation
  1. * Non-femoral access
  2. * Previous repair or intervention of the common femoral artery
  3. * Previous pseudoaneurysm of the common femoral artery
  4. * Children below 18 years, prisoners, and patients who are unable to provide consent are excluded.
  5. * In another research study that has not granted permission to dual-enroll.

Contacts and Locations

Study Locations (Sites)

Baylor Scott & White The Heart Hospital - Plano
Plano, Texas, 75093
United States

Collaborators and Investigators

Sponsor: Baylor Research 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 Date2025-02-12
Study Completion Date2025-10-15

Study Record Updates

Study Start Date2025-02-12
Study Completion Date2025-10-15

Terms related to this study

Keywords Provided by Researchers

  • Transcatheter aortic valve replacement
  • Perclose Proglide
  • Angioseal

Additional Relevant MeSH Terms

  • Transcatheter Aortic Valve Replacement
  • Closure Technique