RECRUITING

Vascular Closure With a Device Compared to Manual Compression After Atrial Fibrillation Ablation: The LockeT II Study

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Conditions

Atrial FibrillationHemostasis

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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

The LockeT II study is a single center, prospective randomized study. It is intended to study the effectiveness of using LockeT device to gain hemostasis after venous procedures as compared to Manual Compression (MC). Approximately 110 patients will be enrolled.

Official Title

Vascular Closure With Novel Ergonomic External Compression Device Compared to Manual Compression After Atrial Fibrillation Ablation: The LockeT II Study

Quick Facts

Study Start:2023-10-02
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06078735

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. * Must be at least 18 years of age
  2. * Be able to provide consent
  3. * Presenting for planned procedures that require percutaneous venous punctures, such as atrial fibrillation radiofrequency ablation, and where the physician utilizes a LockeT device or MC to close the wound.
  1. * Under the age of 18
  2. * Unable to or unwilling to provide consent
  3. * Cannot comply with study requirements
  4. * Not undergoing procedures that require a percutaneous venous puncture or planned access to the left atrium and/or ventricle
  5. * Subjects whose physician does not use LockeT or MC to close the venous puncture.
  6. * Patient is currently pregnant, as evidenced by positive urine Beta-HCG. (Urine Beta Human chorionic gonadotropin (HCG) will be checked in all females of the reproductive age group).
  7. * If the physician detects a formed hematoma prior to venous closure, that patient will be excluded from the study.

Contacts and Locations

Study Contact

Donita Atkins
CONTACT
816-651-1969
Datkins@kchrf.com

Principal Investigator

Dhanunjaya Lakkireddy, MD
PRINCIPAL_INVESTIGATOR
Kansas City Heart Rhythm Institute

Study Locations (Sites)

Kansas City Heart Rhythm Institute - Roe Clinic
Overland Park, Kansas, 66211
United States
Overland Park Regional Medical Center
Overland Park, Kansas, 66215
United States
Centerpoint Medical Center Clinic
Independence, Missouri, 64057
United States
Centerpoint Medical Center
Independence, Missouri, 64057
United States
Research Medical Center Clinic
Kansas City, Missouri, 64032
United States
Research Medical Center
Kansas City, Missouri, 64032
United States

Collaborators and Investigators

Sponsor: Kansas City Heart Rhythm Research Foundation

  • Dhanunjaya Lakkireddy, MD, PRINCIPAL_INVESTIGATOR, Kansas City Heart Rhythm 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 Date2023-10-02
Study Completion Date2024-12

Study Record Updates

Study Start Date2023-10-02
Study Completion Date2024-12

Terms related to this study

Additional Relevant MeSH Terms

  • Atrial Fibrillation
  • Hemostasis