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

Part of paid clinical trials in Overland Park, Kansas.

Sponsor
Kansas City Heart Rhythm Research Foundation
Study ID
NCT06078735
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vascular closure with LockeT device — 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.

Study Details

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.

Key Dates

Start date
Oct 2, 2023
Status verified
Oct 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

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

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Kansas City Heart Rhythm Institute - Roe ClinicOverland ParkKansas66211
Donita Atkins
[email protected]
816-651-1969
Dhanunjaya Lakkireddy, MD (PRINCIPAL_INVESTIGATOR)
Overland Park Regional Medical CenterOverland ParkKansas66215
Donita Atkins
[email protected]
816-651-1969
Centerpoint Medical CenterIndependenceMissouri64057
Donita Atkins
[email protected]
816-651-1969
Centerpoint Medical Center ClinicIndependenceMissouri64057
Donita Atkins
[email protected]
816-651-1969
Research Medical CenterKansas CityMissouri64032
Donita Atkins
[email protected]
816-651-1969
Naga Venkata K. Pothineni, MD (PRINCIPAL_INVESTIGATOR)
Research Medical Center ClinicKansas CityMissouri64032
Donita Atkins
[email protected]
816-651-1969
Naga Venkata K. Pothineni, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Overland Park, KS

By condition
Atrial fibrillation
By specialty
CardiologyHeart disease
By research site
Kansas City Heart Rhythm Institute - Roe Clinic· Overland Park, KSOverland Park Regional Medical Center· Overland Park, KSCenterpoint Medical Center· Independence, MOCenterpoint Medical Center Clinic· Independence, MOResearch Medical Center· Kansas City, MOResearch Medical Center Clinic· Kansas City, MO

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