CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 110 target
Drug / intervention
Vascular closure with LockeT devicedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06078735
NCT06078735N/ARecruitingUpdate OverdueUpdated 20mo ago · Completion was 18mo ago
Enrollment Stalled
Update Overdue
CompareCT.gov

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

Kansas City Heart Rhythm Research Foundation·interventional·Posted Oct 12, 2023·Updated Oct 29, 2024

In Brief

A clinical study evaluating Vascular closure with LockeT device for Atrial Fibrillation and Hemostasis. Currently recruiting, targeting 110 participants across 6 sites.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation, Hemostasis
CountriesUnited States
Collaborators--

Timeline

N/ARecruitingOverdue
202420252026
First PostedOct 12, 2023
Enrollment StartOct 2, 2023
Primary CompletionDec 1, 2024
TodayJul 1, 2026
Enrollment to primary: 1.2 yearsPosted 2.7 years ago

Interventions

Vascular closure with LockeT devicedevice

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.