Atrial FibrillationNCT06199414
Vascular Closure With Novel External Compression Device: The LockeT Study
An observational study of Atrial Fibrillation and Hemostasis, run by Kansas City Heart Rhythm Research Foundation at 2 sites in United States.
Trial summary
Single center, retrospective review study comparing Figure of Eight suture to LockeT, enrolling approximately 70 patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Hemostasis
- What is being tested?
- Venous Closure
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2024to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include who underwent AF ablation and required F-8 or LockeT post procedure.
Who may be able to join
- All participants must meet the following criteria to be included in this study.
- Subjects must be at least 18 years of age.
- Subjects underwent Atrial Fibrillation radiofrequency ablation procedure.
- Subjects must have undergone F-8 or LockeT for venous closure.
Who cannot join
- If a subject meet any of the following criteria will be excluded from study participation.
- Subjects under the age of 18.
- Subject's electrophysiology procedure is not planned to access the left atrium or ventricle.
- Subjects in which F-8 or a LockeT was not used.
- If the EP physician detected a formed hematoma prior to venous closure, that patient will be excluded from the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kansas City Heart Rhythm Institute - Roe Clinic
Overland Park, Kansas, 66211
Overland Park Regional Medical Center
Overland Park, Kansas, 66215
Donita Atkins
About this study
Official title: Vascular Closure With Novel External Compression Device After Atrial Fibrillation Ablation: The LockeT Study
Single center, retrospective review study comparing Figure of Eight suture to LockeT, enrolling approximately 70 patients.
Read the detailed description
The volume of catheter ablation procedures for the treatment of atrial fibrillation and other arrhythmias are on the rise in the United States and worldwide. Despite refinement in ablation tools and techniques which has led to a significant decline in complication rates, achieving vascular hemostasis following femoral access with large bore sheaths remains a challenge. Manual compression (MC) the current standard of care, requires bedrest, often up to 8 hours. This prolonged bedrest is associated with longer length of stay and at times complications from indwelling catheters.
Other methods of vascular closure include figure-of-eight (F-8) a, subcutaneous suture or Z-stitch or fellow's stitch has been evaluated as a means to achieve homeostasis following major cardiovascular procedures. One pooled meta-analysis of six studies including 982 patients demonstrated that F-8 is safe and effective means of achieving hemostasis. In comparison to MC time to hemostasis was significantly lower and overall access site complications like hematoma, bleeding was also noted to be lower in F-8 group.
In recent years, invasive, vascular closure devices have become popular. However, results continue to suggest that the risk versus benefit has not been definitively demonstrated. LockeT is a new suture retention device designed to closely mimic manual compression without the need for a healthcare professional to stand bedside.
- Conditions
- Atrial Fibrillation, Hemostasis
- Being tested
- Venous Closure
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous ClosureDevice
Vascular closure to achieve vascular hemostasis following femoral access with large bore sheaths in catheter ablation procedures
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Figure-of-eight (F-8) suture | This is the group of subjects for whom Figure-of-eight (F-8) suture is used for their venous closure. Receives: Device: Venous Closure | |
| Subjects with LockeT Device | This is the group of subjects for whom LockeT device is used for their venous closure. Receives: Device: Venous Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of LockeT device - Time to no oozing/hemostasis
To assess the effectiveness of using LockeT to retain sutures and pressure to gain hemostasis after venous procedures.
Time to no oozing/hemostasis (mins/hours)
Measured: 1 week
Effectiveness of LockeT device - Time to Ambulate
To assess the effectiveness of using LockeT to retain sutures and pressure to gain hemostasis after venous procedures.
Time to no oozing/hemostasis (mins/hours)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study startJan 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kansas City Heart Rhythm Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dhanunjaya Lakkireddy, MD, Principal investigator, Kansas City Heart Rhythm Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199414
- Sponsor's protocol ID
- KCHRRF_LockeT Retrospect_0020
- Status last verified
- Dec 2023
- First submitted
- 29 Dec 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Natale A, Mohanty S, Liu PY, Mittal S, Al-Ahmad A, De Lurgio DB, Horton R, Spear W, Bailey S, Bunch J, Musat D, O'Neill P, Compton S, Turakhia MP; AMBULATE Trial Investigators. Venous Vascular Closure System Versus Manual Compression Following Multiple Access Electrophysiology Procedures: The AMBULATE Trial. JACC Clin Electrophysiol. 2020 Jan;6(1):111-124. doi: 10.1016/j.jacep.2019.08.013. Epub 2019 Oct 30.
PubMed 31971899Mujer MT, Al-Abcha A, Flores J, Saleh Y, Robinson P. A comparison of figure-of-8-suture versus manual compression for venous access closure after cardiac procedures: An updated meta-analysis. Pacing Clin Electrophysiol. 2020 Aug;43(8):856-865. doi: 10.1111/pace.14008. Epub 2020 Jul 20.
PubMed 32638389Atti V, Turagam MK, Garg J, Alratroot A, Abela GS, Rayamajhi S, Lakkireddy D. Efficacy and safety of figure-of-eight suture versus manual pressure for venous access closure: a systematic review and meta-analysis. J Interv Card Electrophysiol. 2020 Apr;57(3):379-385. doi: 10.1007/s10840-019-00547-6. Epub 2019 Apr 18.
PubMed 31001767Jensen CJ, Schnur M, Lask S, Attanasio P, Gotzmann M, Kara K, Hanefeld C, Mugge A, Wutzler A. Feasibility of the Figure-of-8-Suture as Venous Closure in Interventional Electrophysiology: One Strategy for All? Int J Med Sci. 2020 Apr 6;17(7):965-969. doi: 10.7150/ijms.42593. eCollection 2020.
PubMed 32308550
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Closure With Novel External Compression Device After Atrial Fibrillation Ablation: The LockeT Study
- ClinicalTrials.gov ID
- NCT06199414
- Acronym / sponsor ID
- KCHRRF_LockeT Retrospect_0020
- Conditions
- Atrial Fibrillation, Hemostasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Kansas City Heart Rhythm Research FoundationUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single center, retrospective review study comparing Figure of Eight suture to LockeT, enrolling approximately 70 patients.
Detailed description
The volume of catheter ablation procedures for the treatment of atrial fibrillation and other arrhythmias are on the rise in the United States and worldwide. Despite refinement in ablation tools and techniques which has led to a significant decline in complication rates, achieving vascular hemostasis following femoral access with large bore sheaths remains a challenge. Manual compression (MC) the current standard of care, requires bedrest, often up to 8 hours. This prolonged bedrest is associated with longer length of stay and at times complications from indwelling catheters.
Other methods of vascular closure include figure-of-eight (F-8) a, subcutaneous suture or Z-stitch or fellow's stitch has been evaluated as a means to achieve homeostasis following major cardiovascular procedures. One pooled meta-analysis of six studies including 982 patients demonstrated that F-8 is safe and effective means of achieving hemostasis. In comparison to MC time to hemostasis was significantly lower and overall access site complications like hematoma, bleeding was also noted to be lower in F-8 group.
In recent years, invasive, vascular closure devices have become popular. However, results continue to suggest that the risk versus benefit has not been definitively demonstrated. LockeT is a new suture retention device designed to closely mimic manual compression without the need for a healthcare professional to stand bedside.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with Figure-of-eight (F-8) suture | – | Device: Venous ClosureThis is the group of subjects for whom Figure-of-eight (F-8) suture is used for their venous closure. |
| Subjects with LockeT Device | – | Device: Venous ClosureThis is the group of subjects for whom LockeT device is used for their venous closure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include who underwent AF ablation and required F-8 or LockeT post procedure.
Key inclusion criteria (4 listed)
- All participants must meet the following criteria to be included in this study.
- Subjects must be at least 18 years of age.
- Subjects underwent Atrial Fibrillation radiofrequency ablation procedure.
- Subjects must have undergone F-8 or LockeT for venous closure.
Key exclusion criteria (5 listed)
- If a subject meet any of the following criteria will be excluded from study participation.
- Subjects under the age of 18.
- Subject's electrophysiology procedure is not planned to access the left atrium or ventricle.
- Subjects in which F-8 or a LockeT was not used.
- If the EP physician detected a formed hematoma prior to venous closure, that patient will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venous ClosureVascular closure to achieve vascular hemostasis following femoral access with large bore sheaths in catheter ablation procedures | Device | Subjects with Figure-of-eight (F-8) suture, Subjects with LockeT Device |
Primary outcome
Effectiveness of LockeT device - Time to no oozing/hemostasis
Time frame: 1 week
To assess the effectiveness of using LockeT to retain sutures and pressure to gain hemostasis after venous procedures. Time to no oozing/hemostasis (mins/hours)
Effectiveness of LockeT device - Time to Ambulate
Time frame: 1 week
To assess the effectiveness of using LockeT to retain sutures and pressure to gain hemostasis after venous procedures. Time to no oozing/hemostasis (mins/hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Background: PubMed 31971899Natale A, Mohanty S, Liu PY, Mittal S, Al-Ahmad A, De Lurgio DB, Horton R, Spear W, Bailey S, Bunch J, Musat D, O'Neill P, Compton S, Turakhia MP; AMBULATE Trial Investigators. Venous Vascular Closure System Versus Manual Compression Following Multiple Access Electrophysiology Procedures: The AMBULATE Trial. JACC Clin Electrophysiol. 2020 Jan;6(1):111-124. doi: 10.1016/j.jacep.2019.08.013. Epub 2019 Oct 30.
- Background: PubMed 32638389Mujer MT, Al-Abcha A, Flores J, Saleh Y, Robinson P. A comparison of figure-of-8-suture versus manual compression for venous access closure after cardiac procedures: An updated meta-analysis. Pacing Clin Electrophysiol. 2020 Aug;43(8):856-865. doi: 10.1111/pace.14008. Epub 2020 Jul 20.
- Background: PubMed 31001767Atti V, Turagam MK, Garg J, Alratroot A, Abela GS, Rayamajhi S, Lakkireddy D. Efficacy and safety of figure-of-eight suture versus manual pressure for venous access closure: a systematic review and meta-analysis. J Interv Card Electrophysiol. 2020 Apr;57(3):379-385. doi: 10.1007/s10840-019-00547-6. Epub 2019 Apr 18.
- Background: PubMed 32308550Jensen CJ, Schnur M, Lask S, Attanasio P, Gotzmann M, Kara K, Hanefeld C, Mugge A, Wutzler A. Feasibility of the Figure-of-8-Suture as Venous Closure in Interventional Electrophysiology: One Strategy for All? Int J Med Sci. 2020 Apr 6;17(7):965-969. doi: 10.7150/ijms.42593. eCollection 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dhanunjaya Lakkireddy, MD principal investigator
Kansas City Heart Rhythm Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Hemostasis, run by Kansas City Heart Rhythm Research Foundation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Donita Atkins (816-651-1969, datkins@kchrf.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of LockeT device - Time to no oozing/hemostasis (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06199414, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.