Atrial FibrillationEight-CLOVERNCT07827287
Utility of the Perclose ProGlide™ Suture-Mediated Closure Device After Cardiologic Procedures Via the Femoral Vein Approach (Eight-Clover)
A study testing Perclose ProStyle™ Suture-Mediated Closure System and Conventional Hemostasis (Manual Compression or Figure-of-Eight Suture) in people with Atrial Fibrillation and Atrial Septal Defect, run by Ewha Womans University Mokdong Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the clinical efficacy and safety of the Perclose ProStyle™ Suture-Mediated Closure Device in patients undergoing cardiologic procedures via a femoral vein approach using a sheath size of 8 French or larger.Patients receiving cardiac interventions-such as atrial fibrillation… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Atrial Fibrillation, Atrial Septal Defect, Vascular Closure Device
- What is being tested?
- Perclose ProStyle™ Suture-Mediated Closure System and Conventional Hemostasis (Manual Compression or Figure-of-Eight Suture)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Feb 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 19 years or older undergoing cardiologic procedures via femoral vein access
- Patients who provide written informed consent to participate in the study
Who cannot join
- Patients with active systemic infection or local infection at the vascular access site
- Patients with known severe allergy to contrast media or device components
- Patients unable to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Utility of the Perclose ProGlide™ Suture-Mediated Closure Device After Cardiologic Procedures Via the Femoral Vein Approach ( Eight-CLOVER Trial)
The purpose of this study is to evaluate the clinical efficacy and safety of the Perclose ProStyle™ Suture-Mediated Closure Device in patients undergoing cardiologic procedures via a femoral vein approach using a sheath size of 8 French or larger.Patients receiving cardiac interventions-such as atrial fibrillation catheter ablation, leadless pacemaker insertion, atrial septal defect (ASD) patch closure, or left atrial appendage occlusion (LAAO)-will be randomly assigned in a 1:1 ratio to either the intervention group (using the Perclose ProStyle™ device for vascular closure) or the control group (using conventional manual compression or figure-of-eight suture).The primary outcome of the study is the time to ambulation after the procedure. Secondary outcomes include time to hemostasis, time to discharge eligibility, patient satisfaction scores, and the incidence of vascular complications within 30 days post-procedure.
Read the detailed description
Cardiac interventional procedures using large-bore sheaths (>= 8 French) via femoral vein access are associated with an increased risk of vascular access-related complications, prolonged bed rest, and delayed ambulation. While suture-mediated vascular closure devices like Perclose ProStyle™ have shown benefits in reducing hemostasis and recovery times in Western populations, prospective multi-center data in Korean patients remain limited.This prospective, randomized, open-label, parallel-group multi-center study aims to enroll a total of 200 patients across Ewha Womans University Mokdong Hospital and Seoul Hospital. Patients will be evaluated at baseline, on the day of the procedure, prior to discharge, and via a 30-day follow-up visit or phone call to assess safety and efficacy endpoints.
- Being tested
- Perclose ProStyle™ Suture-Mediated Closure System, Conventional Hemostasis (Manual Compression or Figure-of-Eight Suture)
- Keywords
- Perclose ProStyle, Femoral Vein Access, Catheter Ablation, Left Atrial Appendage Occlusion, Leadless Pacemaker
- Medical subject headings
- Atrial Fibrillation, Heart Septal Defects, Atrial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perclose ProStyle™ Suture-Mediated Closure SystemDevice
Vascular closure device applied to the femoral vein access site immediately following sheath removal.
Conventional Hemostasis (Manual Compression or Figure-of-Eight Suture)Other
Hemostasis achieved using standard manual compression or figure-of-eight suture technique at the femoral vein access site.
| Study group | Role | What they receive |
|---|---|---|
| experimental Group (Perclose ProStyle) | Experimental | Patients undergoing cardiologic procedures via femoral vein access who receive vascular closure using the Perclose ProStyle™ device Receives: Device: Perclose ProStyle™ Suture-Mediated Closure System |
| Control Group (Conventional Closure) | Active comparator | Description: Patients undergoing cardiologic procedures via femoral vein access who receive conventional vascular closure (manual compression or figure-of-eight suture) Receives: Other: Conventional Hemostasis (Manual Compression or Figure-of-Eight Suture) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Ambulation
Time elapsed from sheath removal until the patient achieves full ambulation
Measured: Up to 24 hours post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start2 Feb 2026
- Primary completion31 May 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University Mokdong Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ewha Womans University Seoul Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07827287
- Sponsor's protocol ID
- CLOVER
- Acronym
- Eight-CLOVER
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of the Perclose ProGlide™ Suture-Mediated Closure Device After Cardiologic Procedures Via the Femoral Vein Approach ( Eight-CLOVER Trial)
- ClinicalTrials.gov ID
- NCT07827287
- Acronym / sponsor ID
- Eight-CLOVER / CLOVER
- Keywords
- Perclose ProStyle, Femoral Vein Access, Catheter Ablation, Left Atrial Appendage Occlusion, Leadless Pacemaker
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ewha Womans University Mokdong HospitalUniversity, hospital or other
- Collaborators
- Ewha Womans University Seoul Hospital
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 18 Sep 2026 (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.
The purpose of this study is to evaluate the clinical efficacy and safety of the Perclose ProStyle™ Suture-Mediated Closure Device in patients undergoing cardiologic procedures via a femoral vein approach using a sheath size of 8 French or larger.Patients receiving cardiac interventions-such as atrial fibrillation catheter ablation, leadless pacemaker insertion, atrial septal defect (ASD) patch closure, or left atrial appendage occlusion (LAAO)-will be randomly assigned in a 1:1 ratio to either the intervention group (using the Perclose ProStyle™ device for vascular closure) or the control group (using conventional manual compression or figure-of-eight suture).The primary outcome of the study is the time to ambulation after the procedure. Secondary outcomes include time to hemostasis, time to discharge eligibility, patient satisfaction scores, and the incidence of vascular complications within 30 days post-procedure.
Detailed description
Cardiac interventional procedures using large-bore sheaths (>= 8 French) via femoral vein access are associated with an increased risk of vascular access-related complications, prolonged bed rest, and delayed ambulation. While suture-mediated vascular closure devices like Perclose ProStyle™ have shown benefits in reducing hemostasis and recovery times in Western populations, prospective multi-center data in Korean patients remain limited.This prospective, randomized, open-label, parallel-group multi-center study aims to enroll a total of 200 patients across Ewha Womans University Mokdong Hospital and Seoul Hospital. Patients will be evaluated at baseline, on the day of the procedure, prior to discharge, and via a 30-day follow-up visit or phone call to assess safety and efficacy endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental Group (Perclose ProStyle) | Experimental | Device: Perclose ProStyle™ Suture-Mediated Closure SystemPatients undergoing cardiologic procedures via femoral vein access who receive vascular closure using the Perclose ProStyle™ device |
| Control Group (Conventional Closure) | Active comparator | Other: Conventional Hemostasis (Manual Compression or Figure-of-Eight Suture)Description: Patients undergoing cardiologic procedures via femoral vein access who receive conventional vascular closure (manual compression or figure-of-eight suture) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 19 years or older undergoing cardiologic procedures via femoral vein access
- Patients who provide written informed consent to participate in the study
Key exclusion criteria (3 listed)
- Patients with active systemic infection or local infection at the vascular access site
- Patients with known severe allergy to contrast media or device components
- Patients unable to provide informed consent
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 |
|---|---|---|
| Perclose ProStyle™ Suture-Mediated Closure SystemVascular closure device applied to the femoral vein access site immediately following sheath removal. | Device | experimental Group (Perclose ProStyle) |
| Conventional Hemostasis (Manual Compression or Figure-of-Eight Suture)Hemostasis achieved using standard manual compression or figure-of-eight suture technique at the femoral vein access site. | Other | Control Group (Conventional Closure) |
Primary outcome
Time to Ambulation
Time frame: Up to 24 hours post-procedure
Time elapsed from sheath removal until the patient achieves full ambulation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perclose ProStyle™ Suture-Mediated Closure System and Conventional Hemostasis (Manual Compression or Figure-of-Eight Suture) in people with Atrial Fibrillation and Atrial Septal Defect, run by Ewha Womans University Mokdong Hospital at 1 site in South Korea.
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 2 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Ambulation (time frame: Up to 24 hours post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2026.