Venous Vascular Closure System Versus Manual Compression Following Multiple Access Electrophysiology Procedures: The AMBULATE Trial.
Andrea Natale, Sanghamitra Mohanty, P Y Liu...
https://pubmed.ncbi.nlm.nih.gov/31971899Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06078735
Vascular Closure With Novel Ergonomic External Compression Device Compared to Manual Compression After Atrial Fibrillation Ablation: The LockeT II Study
Led by Kansas City Heart Rhythm Research Foundation · Updated on 2024-10-29
110
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness of the LockeT device for achieving hemostasis after venous procedures compared to the current standard method of Manual Compression (MC). The study focuses on patients undergoing catheter ablation for atrial fibrillation and other arrhythmias, where vascular closure following large-bore sheath femoral access remains challenging. The trial is prospective, randomized, and conducted at a single center, enrolling around 110 patients. Participants are randomly assigned to one of two groups: the LockeT device group or the Manual Compression group. In the LockeT group, a healthcare professional places the LockeT device with suture above the wound to apply compression, aiming to mimic manual pressure but without continuous bedside presence. After hemostasis is achieved and before walking, the device and sutures are removed. The Manual Compression group receives the standard care of manual pressure to close the access site wound. During the study, researchers will assess the effectiveness of the LockeT device within 2 days following the procedure. They will also evaluate benefits to patients, physicians, and nursing staff, measure patient discomfort, track hematoma or bruising incidence, monitor safety, and compare labor and device costs. Participants will be closely monitored during this short follow-up period to understand outcomes related to vascular closure methods.
CONDITIONS
Brief Title
Vascular Closure With a Device Compared to Manual Compression After Atrial Fibrillation Ablation: The LockeT II Study
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Must be at least 18 years of age
- Able to provide consent
- Undergoing planned procedures requiring percutaneous venous punctures, such as atrial fibrillation radiofrequency ablation
- Physician intends to use LockeT device or manual compression to close the wound
You will not qualify if you...
- Under 18 years of age
- Unable or unwilling to provide consent
- Unable to comply with study requirements
- Not undergoing procedures requiring percutaneous venous puncture or access to the left atrium or ventricle
- Physician does not use LockeT or manual compression to close puncture
- Currently pregnant (positive urine Beta-HCG test for females of reproductive age)
- Presence of formed hematoma before venous closure procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Implementation
Duration - Up to 2 days
Participants undergo vascular closure using either the LockeT suture retention device or manual compression after atrial fibrillation ablation.
1 procedure visit and 1 device removal visit
Trial Site Locations
Total: 6 locations
1
Kansas City Heart Rhythm Institute - Roe Clinic
Overland Park, Kansas, United States, 66211
Actively Recruiting
2
Overland Park Regional Medical Center
Overland Park, Kansas, United States, 66215
Actively Recruiting
3
Centerpoint Medical Center Clinic
Independence, Missouri, United States, 64057
Actively Recruiting
4
Centerpoint Medical Center
Independence, Missouri, United States, 64057
Actively Recruiting
5
Research Medical Center Clinic
Kansas City, Missouri, United States, 64032
Actively Recruiting
6
Research Medical Center
Kansas City, Missouri, United States, 64032
Actively Recruiting
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Research Team
D
Donita Atkins
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Published Research Related To This Trial
A comparison of figure-of-8-suture versus manual compression for venous access closure after cardiac procedures: An updated meta-analysis.
Mark Terence Mujer, Abdullah Al-Abcha, Jairus Flores...
https://pubmed.ncbi.nlm.nih.gov/32638389Efficacy and safety of figure-of-eight suture versus manual pressure for venous access closure: a systematic review and meta-analysis.
Varunsiri Atti, Mohit K Turagam, Jalaj Garg...
https://pubmed.ncbi.nlm.nih.gov/31001767Feasibility of the Figure-of-8-Suture as Venous Closure in Interventional Electrophysiology: One Strategy for All?
Christoph J Jensen, Miriam Schnur, Sebastian Lask...
https://pubmed.ncbi.nlm.nih.gov/32308550