Tokyo, Dec. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059827) titled 'Evaluation of the Efficacy of Rotor-Guided Pulsed Field Ablation for Extended Pulmonary Vein Isolation in Patients with Persistent Atrial Fibrillation' on Dec. 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Kita-Harima Medical Center
Condition:
Condition - Atrial fibrillation
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to examine whether ExTRa mapping-guided extended pulmonary vein isolation during catheter ablation for persistent atrial fibrillation improves the non-recurrence rate of atrial arrhythmias.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - ExTRa Mapping of the left atrium and pulmonary vein (PV) antrum will be performed prior to pulmonary vein isolation (PVI). Areas with a non-passive ratio >=25% by Advisor HD-Grid will be marked on the NAVX system. In addition to standard PVI, pulsed field ablation (PFA) will be applied to modify the rotor areas around the left atrial PV antrum.
Interventions/Control_2 - No additional ablation after pulmonary veins isolation
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - First time ablation procedure for persistent atrial fibrillation
Patients from who we get written informed consent
Key exclusion criteria - Age >= 85 years
Estimated glomerular filtration rate (eGFR) = 50 mm on transthoracic echocardiography
Left ventricular ejection fraction (LVEF) <= 35%
chronic heart failure of NYHA class IV
Patients with implanted pacemakers or implantable cardioverter-defibrillators (ICDs)
Target Size - 150
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 14 Day
Anticipated trial start date - 2025 Year 12 Month 01 Day
Last follow-up date - 2028 Year 10 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067785
Disclaimer: Curated by HT Syndication.