atrial fibrillation
Conditions
Interventions
Venous vascular closure device (VVCD) group: Hemostasis is performed using the VASCADE MVP system.
Control group: Hemostasis is performed using the purse-string suture technique.
Sponsors
Hiroshima University
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Japan
Contacts
Public ContactMaeda Junji
Hiroshima University Hospital Department of Cardiovascular Medicine
Outcome results
None listed