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Procedure
Vascular Closure Device for Atrial Fibrillation
N/A
Recruiting
Led By Dhanunjaya Lakkireddy, MD
Research Sponsored by Kansas City Heart Rhythm Research Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Must be at least 18 years of age
Must not have
Not undergoing procedures that require a percutaneous venous puncture or planned access to the left atrium and/or ventricle
If the physician detects a formed hematoma prior to venous closure, that patient will be excluded from the study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 days
Awards & highlights
Summary
This trial will compare a new device to manual compression to see which is more effective at stopping bleeding from veins after procedures. 110 people will take part.
Who is the study for?
This trial is for adults who can consent and are undergoing venous procedures like atrial fibrillation ablation, where a LockeT device or manual compression (MC) will be used to close the wound. It's not for those under 18, unable to consent, pregnant women, or if their doctor doesn't use these closure methods.
What is being tested?
The LockeT II study is comparing two ways of stopping bleeding after vein procedures: using a new device called LockeT versus traditional hand pressure (Manual Compression). About 110 patients will participate in this research at one medical center.
What are the potential side effects?
Potential side effects may include discomfort at the puncture site, bruising or bleeding complications related to the vascular closure method used. The specific side effects of the LockeT device compared to manual compression will be studied.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for a procedure that involves vein punctures and uses a specific device for closure.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not scheduled for any procedures involving needle entry into veins or heart chambers.
Select...
I do not have a blood clot in my vein as detected by a doctor.
Select...
I am under 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Effectiveness of using the LockeT suture retention device
Secondary study objectives
Comparison of Manual Compression labor cost and Locket device cost
Incidence of hematoma/ecchymosis
Patient discomfort with Locket device
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: LockeTExperimental Treatment1 Intervention
These are the patients assigned for LockeT device arm to close the access site wound.
Group II: Manual compressionActive Control1 Intervention
These are the patients assigned for Manual Compression arm to close the access site wound.
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Who is running the clinical trial?
Kansas City Heart Rhythm Research FoundationLead Sponsor
27 Previous Clinical Trials
13,688 Total Patients Enrolled
1 Trials studying Hemostasis
70 Patients Enrolled for Hemostasis
Dhanunjaya Lakkireddy, MDPrincipal InvestigatorKansas City Heart Rhythm Institute
29 Previous Clinical Trials
9,550 Total Patients Enrolled
1 Trials studying Hemostasis
70 Patients Enrolled for Hemostasis
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