Recruiting

Vascular Closure

Sponsor:

Kansas City Heart Rhythm Research Foundation

Code:

NCT06078735

Conditions

Atrial Fibrillation

Hemostasis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vascular closure with LockeT device

Study Details

Brief 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.

Conditions

Atrial Fibrillation

Hemostasis

Study ID

NCT06078735

Start date

Oct 2, 2023

Status verified date

Oct, 2024

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 age group).
  • If the physician detects a formed hematoma prior to venous closure, that patient will be excluded from the study.

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: LockeT

These are the patients assigned for LockeT device arm to close the access site wound.

no intervention: Manual compression

These are the patients assigned for Manual Compression arm to close the access site wound.

Interventions

Vascular closure with LockeT device

For subjects that are assigned to the LockeT device arm, the healthcare professional will place the LockeT with suture above the wound to achieve compression instead of manually holding pressure on the sutures. After hemostasis is achieved and prior to ambulation the LockeT will be removed followed by suture removal.

Primary outcome measure

  • Effectiveness of using the LockeT suture retention device [ Time Frame: 2 Days ]

Central Contacts and Locations

Central contacts

Donita Atkins

816-651-1969Datkins@kchrf.com

Locations

Kansas City Heart Rhythm Institute - Roe Clinic

Recruiting

Overland Park, Kansas, United States, 66211

Contacts

Donita Atkins

816-651-1969Datkins@kchrf.com

Principal Investigator:

Dhanunjaya Lakkireddy, MD

Overland Park Regional Medical Center

Recruiting

Overland Park, Kansas, United States, 66215

Contacts

Donita Atkins

816-651-1969Datkins@kchrf.com

Centerpoint Medical Center Clinic

Recruiting

Independence, Missouri, United States, 64057

Contacts

Donita Atkins

816-651-1969datkins@kchrf.com

Centerpoint Medical Center

Recruiting

Independence, Missouri, United States, 64057

Contacts

Donita Atkins

816-651-1969datkins@kchrf.com

Research Medical Center Clinic

Recruiting

Kansas City, Missouri, United States, 64032

Contacts

Donita Atkins

816-651-1969Datkins@kchrf.com

Principal Investigator:

Naga Venkata K. Pothineni, MD

Research Medical Center

Recruiting

Kansas City, Missouri, United States, 64032

Contacts

Donita Atkins

816-651-1969Datkins@kchrf.com

Principal Investigator:

Naga Venkata K. Pothineni, MD

More Information

Sponsor

Kansas City Heart Rhythm Research Foundation

Last update posted

Oct 29, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kansas City Heart Rhythm Research Foundation on 2024-10-29.