Comparing a device to manual compression for closing blood vessels after heart procedure
Vascular Closure With Novel Ergonomic External Compression Device Compared to Manual Compression After Atrial Fibrillation Ablation: The LockeT II Study
This study is testing a new device to see if it can help close blood vessels after heart procedures better than the usual method of manual compression, making recovery easier for patients with atrial fibrillation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kansas City Heart Rhythm Research Foundation Academic / other |
| Locations | 6 sites (Overland Park, Kansas and 5 other locations) |
| Trial ID | NCT06078735 on ClinicalTrials.gov |
What this trial studies
The LockeT II study is a prospective randomized trial aimed at evaluating the effectiveness of the LockeT device for achieving hemostasis after venous procedures, specifically in patients undergoing atrial fibrillation ablation. This study will enroll approximately 110 patients and compare the device's performance to the current standard of manual compression, which requires prolonged bedrest and can lead to complications. The LockeT device is designed to mimic manual compression while distributing tension over a larger area, potentially reducing the need for healthcare professionals to remain at the bedside during recovery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for atrial fibrillation procedures requiring venous punctures.
Not a fit: Patients under 18, those unable to provide consent, or those not undergoing the specified procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to shorter recovery times and reduced complications for patients undergoing atrial fibrillation ablation.
How similar studies have performed: While the use of vascular closure devices is becoming more common, the specific approach of the LockeT device has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Must be at least 18 years of age * Be able to provide consent * 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. Exclusion Criteria: * Under the age of 18 * Unable to or unwilling to provide consent * Cannot comply with study requirements * Not undergoing procedures that require a percutaneous venous puncture or planned access to the left atrium and/or ventricle * Subjects whose physician does not use LockeT or MC to close the venous puncture. * 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). * If the physician detects a formed hematoma prior to venous closure, that patient will be excluded from the study.
Where this trial is running
Overland Park, Kansas and 5 other locations
- Kansas City Heart Rhythm Institute - Roe Clinic — Overland Park, Kansas, United States (Recruiting)
- Overland Park Regional Medical Center — Overland Park, Kansas, United States (Recruiting)
- Centerpoint Medical Center Clinic — Independence, Missouri, United States (Recruiting)
- Centerpoint Medical Center — Independence, Missouri, United States (Recruiting)
- Research Medical Center Clinic — Kansas City, Missouri, United States (Recruiting)
- Research Medical Center — Kansas City, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Dhanunjaya Lakkireddy, MD — Kansas City Heart Rhythm Institute
- Study coordinator: Donita Atkins
- Email: Datkins@kchrf.com
- Phone: 816-651-1969
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.