RECRUITING

Comparison of Single vs. Dual Perclose Devices for Large-Bore Access Closure in TAVR

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Conditions

Transcatheter Aortic Valve Replacementaortic valve diseasesPerclose devicearteriotomy

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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

This study will compare the use of one Perclose device to the usual approach of two devices for pre-closure during Transcatheter Aortic Valve Replacement (TAVR). The study will compare the time it takes for bleeding to stop using the different closure approaches. The study will also compare complications when using one Perclose device versus two.

Official Title

Comparative Efficacy of Single vs. Dual Perclose Devices for Large-Bore Access Closure in Transcatheter Aortic Valve Replacement: A Randomized Controlled Trial

Quick Facts

Study Start:2025-06-16
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06871774

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. * Patient age 18 or older
  2. * Transfemoral transcatheter aortic valve replacement (TAVR)
  3. * Implantation of CoreValve replacement valve
  4. * Access using 14 or 16 French sheaths
  5. * English speaking
  1. * Alternative Access Routes: Patients undergoing transcatheter aortic valve replacement (TAVR) via alternative access routes such as subclavian access or transapical access.
  2. * Planned Surgical Cut-Down: Patients planned for surgical cut-down procedures rather than percutaneous access.
  3. * Vascular Access Complications: Patients with known vascular complications at the femoral access site, such as residual hematoma, recent femoral arteriotomy or venotomy within the past 10 days, history of significant vascular complications or prior intravascular closure device use within the previous 30 days.
  4. * Arterial or Venous Issues: Patients with small femoral arteries or veins (\<5 mm in diameter), patients with access sites located in vascular grafts.
  5. * Infection or Inflammation: Active systemic or cutaneous infection or inflammation in the vicinity of the groin.
  6. * Coagulation and Hematological Disorders: Known history of bleeding diathesis, coagulopathy, hypercoagulability, or platelet count \<100,000 cells/mm³. Pre-existing immunodeficiency disorder or chronic use of high-dose systemic steroids.
  7. * Severe Morbidity: Severe co-existing morbidities with a life expectancy less than 12 months.
  8. * Mobility Issues: Patients unable to routinely walk at least 20 feet without assistance.
  9. * Recent Anticoagulation: Use of low molecular weight heparin (LMWH) within 8 hours before or after the procedure.
  10. * Pregnancy and Lactation: Pregnant or lactating women.
  11. * Incompatible Procedure Plan: Patients receiving the Edwards Sapien valve (Edwards Lifesciences, Irvine, CA)
  12. * Contraindications: Patients with contraindications for the use of Perclose device.

Contacts and Locations

Study Contact

Suhail Q Allaqaband, MD
CONTACT
414-649-3491
suhail.allaqaband@aah.org

Principal Investigator

Suhail Q Allaqaband, MD
PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences

Study Locations (Sites)

Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

  • Suhail Q Allaqaband, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

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 Date2025-06-16
Study Completion Date2026-07

Study Record Updates

Study Start Date2025-06-16
Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

  • aortic valve diseases
  • Perclose device
  • arteriotomy

Additional Relevant MeSH Terms

  • Transcatheter Aortic Valve Replacement