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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 days

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

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I am scheduled for a procedure that involves vein punctures and uses a specific device for closure.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Effectiveness of using the LockeT suture retention device

Secondary outcome measures

Comparison of Manual Compression labor cost and Locket device cost

Incidence of hematoma/ecchymosis

Patient discomfort with Locket device

+2 more

Trial 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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kansas City Heart Rhythm Research FoundationLead Sponsor

26 Previous Clinical Trials

11,862 Total Patients Enrolled

1 Trials studying Hemostasis

70 Patients Enrolled for Hemostasis

Dhanunjaya Lakkireddy, MDPrincipal InvestigatorKansas City Heart Rhythm Institute

28 Previous Clinical Trials

8,114 Total Patients Enrolled

1 Trials studying Hemostasis

70 Patients Enrolled for Hemostasis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings currently available to join this experiment?

"The research project, which was first posted on October 2nd 2023 on clinicaltrials.gov, is actively recruiting participants. This trial has been refreshed as recently as October 3rd of the same year."

Answered by AI

What is the capacity of participants in this clinical trial?

"Affirmative. Information available on clinicaltrials.gov shows that this experiment, which was originally published on October 2nd 2023 is actively looking for participants. A total of 110 patients need to be recruited from 6 different medical facilities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Vascular Closure With a Device Compared to Manual Compression After Atrial Fibrillation Ablation: The LockeT II Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06078735.

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