Vascular Closure With a Device Compared to Manual Compression After Atrial Fibrillation Ab
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). Approximately 110 patients will be enrolled.
| Condition(s) | Atrial Fibrillation, Hemostasis |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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). Approximately 110 patients will be enrolled. |
| Who can participate | 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 a |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Kansas City Heart Rhythm Research Foundation |
| Locations | Overland Park, Kansas, United States; Overland Park, Kansas, United States; Independence, Missouri, United States; Independence, Missouri, United States; Kansas City, Missouri, United States; Kansas City, Missouri, United States |
| Start date | 2023-10-02 |
| NCT ID | NCT06078735 |
| Official listing | https://clinicaltrials.gov/study/NCT06078735 |