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Compares treatment options for Atrial Fibrillation
Official title Vascular Closure With a Device Compared to Manual Compression After Atrial Fibrillation Ablation: The LockeT II Study
ClinicalTrials.gov ID: NCT06078735
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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
- people 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...
See the full eligibility 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.
- 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
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Overland Park, Kansas, United States
- Independence, Missouri, United States
- Kansas City, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Overland Park, Kansas, United States; Independence, Missouri, United States; Kansas City, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.