UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062628 |
|---|---|
| Receipt number | R000071689 |
| Scientific Title | A multicenter prospective study of the efficacy of figure-of-eight and modified figure-of-eight sutures for femoral venous hemostasis after catheter ablation |
| Date of disclosure of the study information | 2026/08/20 |
| Last modified on | 2026/08/20 00:19:46 |
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Basic information
Public title
A study comparing two figure-of-eight suture techniques for femoral venous hemostasis after atrial fibrillation ablation
Acronym
FoE/mFoE Study
Scientific Title
A multicenter prospective study of the efficacy of figure-of-eight and modified figure-of-eight sutures for femoral venous hemostasis after catheter ablation
Scientific Title:Acronym
FoE/mFoE Study
Region
| Japan |
Condition
Condition
Symptomatic paroxysmal or persistent atrial fibrillation scheduled for pulmonary vein isolation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare conventional figure-of-eight suturing (FoE) with modified figure-of-eight suturing (mFoE) for femoral venous hemostasis after atrial fibrillation catheter ablation. The primary outcome is the non-inferiority of time to hemostasis (TTH; the time from sheath removal to confirmed hemostasis). As a secondary outcome, a safety-prioritized hierarchical composite comprising (1) serious vascular access-site complications, (2) bleeding complications requiring additional manual compression, (3) access-site hematoma, and (4) TTH will be evaluated descriptively using the win ratio; no confirmatory superiority or non-inferiority claim will be made for this composite. Individual component results will also be reported as supportive analyses. Participants will be allocated 1:1 by alternation according to the order of participant registration (quasi-randomization).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome is the non-inferiority of time to hemostasis (TTH) for the mFoE group compared with the FoE group. TTH is defined as the time in minutes from sheath removal to confirmed hemostasis, assessed on the day of the procedure after sheath removal.
Key secondary outcomes
The secondary outcome is a safety-prioritized hierarchical composite consisting of: (1) serious vascular access-site complications; (2) bleeding complications requiring additional manual compression; (3) access-site hematoma; and (4) TTH. The mFoE and FoE groups will be compared using the win ratio (including win difference and win odds), reported descriptively; no confirmatory superiority or non-inferiority claim will be made. Components 1--3 will be assessed from sheath removal through hospital discharge, with access-site findings evaluated by ultrasonography. Incidence of each component will also be reported individually as supportive analyses. Other secondary outcomes will include rebleeding, hemoglobin decrease, other bleeding or vascular complications, and patient or procedural factors associated with TTH. Assessments will be performed from the day of the procedure through hospital discharge, including next-day access-site ultrasonography.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Conventional figure-of-eight suture (FoE) group: after completion of ablation, a conventional FoE suture is placed once, with the needle passed perpendicular to the femoral venous sheath. Time to hemostasis is measured after sheath removal. Bed rest is discontinued after 4 hours once hemostasis is confirmed. The access site is followed through hospital discharge, including ultrasonographic assessment on the day after the procedure.
Interventions/Control_2
Modified figure-of-eight suture (mFoE) group: after completion of ablation, an mFoE suture is placed once. The needle is passed parallel to the femoral venous sheath to avoid sheath contact and captures only subcutaneous tissue. Subsequent measurement of time to hemostasis, 4-hour bed rest, follow-up through hospital discharge, and next-day ultrasonographic assessment are identical to those in the FoE group.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Age 20 years or older; (2) symptomatic paroxysmal or persistent atrial fibrillation; (3) scheduled to undergo atrial fibrillation catheter ablation including pulmonary vein isolation; and (4) provision of written informed consent.
Key exclusion criteria
Patients who do not provide written informed consent to participate in the study.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Oginosawa |
Organization
University of Occupational and Environmental Health, Japan
Division name
The Department of Heart Rhythm Management
Zip code
807-8555
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka 807-8555, Japan
TEL
093-603-1611
y-ogi@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Kobayashi |
Organization
University of Occupational and Environmental Health, Japan
Division name
Department of Cardiology and Nephrology
Zip code
807-8555
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka 807-8555, Japan
TEL
093-603-1611
Homepage URL
koba655696@med.uoeh-u.ac.jp
Sponsor or person
Institute
Kumamoto Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Hospital of the University of Occupational and Environmental Health, Japan; Kitakyushu City Yahata Hospital; Kyushu Rosai Hospital Moji Medical Center
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Ethics Review Committee of Kumamoto Rosai Hospital
Address
1670 Takehara-machi, Yatsushiro, Kumamoto 866-8533, Japan
Tel
0965-33-4151
kazz_kawakami@me.com
Secondary IDs
Secondary IDs
YES
Study ID_1
22-15
Org. issuing International ID_1
Ethics Review Committee of Kumamoto Rosai Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
該当なし
Institutions
Institutions
熊本労災病院（熊本県）、産業医科大学病院（福岡県）、北九州市立八幡病院（福岡県）、門司メディカルセンター（福岡県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 20 | Day |
Last modified on
| 2026 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071689
