UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061241 |
|---|---|
| Receipt number | R000069377 |
| Scientific Title | Comparison of a venous vascular closure device and purse-string suture after catheter ablation: a prospective randomized study |
| Date of disclosure of the study information | 2026/04/13 |
| Last modified on | 2026/04/13 11:29:07 |
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Basic information
Public title
Comparison of a venous vascular closure device and purse-string suture after catheter ablation: a prospective randomized study
Acronym
Comparison of a venous vascular closure device and purse-string suture after catheter ablation: a prospective randomized study
Scientific Title
Comparison of a venous vascular closure device and purse-string suture after catheter ablation: a prospective randomized study
Scientific Title:Acronym
Comparison of a venous vascular closure device and purse-string suture after catheter ablation: a prospective randomized study
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate and compare the efficacy of the VASCADE MVP venous vascular closure device (Haemonetics) versus the purse-string suture technique in achieving safe early ambulation following catheter ablation for atrial fibrillation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The achievement rate of a composite endpoint of successful early ambulation, defined as fulfilling all the following criteria:
Time to ambulation within 4 hours post-procedure.
Absence of clinically significant hematoma (>= 6 cm in diameter).
No requirement for additional hemostatic interventions (additional manual compression >= 10 minutes or other rescue procedures).
Key secondary outcomes
Time to ambulation and time to discharge eligibility.
Hemostasis time and incidence of re-bleeding.
Access-site complications, including minor hematoma (< 6 cm).
Patient satisfaction assessed by a questionnaire (regarding bed rest duration, pain, and discomfort).
Major access-related adverse events up to 30 days post-procedure (safety endpoint).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Venous vascular closure device (VVCD) group: Hemostasis is performed using the VASCADE MVP system.
Interventions/Control_2
Control group: Hemostasis is performed using the purse-string suture technique.
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients scheduled for catheter ablation therapy for atrial fibrillation.
2. Patients aged >= 18 and < 90 years at the time of informed consent.
3. Patients whose general condition is stable at the time of consent, and who are judged by the principal investigator or co-investigators to be able to tolerate the study procedure and follow-up.
4. Patients capable of attending outpatient follow-up for 30 days post-procedure.
5. Patients who have provided written informed consent to participate in this study of their own free will.
Key exclusion criteria
1. Patients in whom catheter ablation for atrial fibrillation is deemed medically inappropriate (e.g., presence of left atrial thrombus, difficulty in continuing anticoagulant therapy).
2. Patients with severe renal impairment (eGFR < 30 mL/min/1.73m2) or renal failure requiring dialysis.
3. Patients with severe hepatic impairment (Child-Pugh class B or C).
4. Patients with a history of cerebrovascular disease (stroke or transient ischemic attack) within 3 months prior to consent.
5. Patients with a bleeding diathesis (e.g., congenital blood coagulation disorder) making it difficult to continue anticoagulant therapy.
6. Women who are pregnant, breastfeeding, or planning to become pregnant.
7. Patients with symptomatic lower limb ischemia ipsilateral to the access site.
8. Patients with extreme morbid obesity (BMI >= 45) or low body weight (BMI < 20).
9. Patients meeting any of the following criteria:
10. History of allergy to bovine-derived products.
11. Presence of permanent hemostatic devices such as metal clips or permanent sutures.
12. Presence of severe complications (e.g., active infection, malignant tumor) that are considered to significantly affect the safety or efficacy evaluation of this study.
13. Patients who have an educational or employment hierarchical relationship with the investigator or co-investigators, which may compromise their voluntary participation in the study.
14. Other patients deemed inappropriate for the study by the investigator or co-investigators.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Okubo |
| Middle name | |
| Last name | Yousaku |
Organization
Hiroshima University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
734-0037
Address
1-2-3 Kasumi, Minami-ku, Hiroshima City, Hiroshima
TEL
082-257-5540
yokubo@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Maeda |
| Middle name | |
| Last name | Junji |
Organization
Hiroshima University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
734-0037
Address
1-2-3 Kasumi, Minami-ku, Hiroshima City, Hiroshima
TEL
082-257-5540
Homepage URL
d232308@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-Ku, Hiroshima
Tel
082-257-1947
iryo-sinsa@office.hiroshima-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | 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 | 04 | Month | 13 | Day |
Last modified on
| 2026 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069377
