Tokyo, May 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061552) titled 'Efficacy and Safety of Flower-Only Catheter Strategy Using Pulsed Field Ablation in Patients with Persistent Atrial Fibrillation' on May 20.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Steel Memorial Yawata Hospital
Condition:
Condition - Persistent atrial fibrillation
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The aim of this study is to demonstrate that pulmonary vein isolation and left atrial posterior wall isolation using flower and olive configurations for pulsed-field ablation (PFA) in persistent atrial fibrillation is non-inferior to the conventional approach using basket, flower, and olive configurations, and is associated with less hemolysis and acute kidney injury.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Conventional method (basket, flower, and olive configurations)
Interventions/Control_2 - Flower strategy (flower and olive configurations only)
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients undergoing PFA for persistent atrial fibrillation
Key exclusion criteria - 1. Patients who have expressed refusal to participate in this study
2. Patients deemed inappropriate for participation by the attending physician
3. Patients on hemodialysis and patients with cardiomyopathy
Target Size - 150
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 02 Month 10 Day
Date of IRB - 2026 Year 02 Month 25 Day
Anticipated trial start date - 2026 Year 02 Month 26 Day
Last follow-up date - 2028 Year 06 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070223
Disclaimer: Curated by HT Syndication.
