Tokyo, Oct. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063392) titled 'Comparison of Left Atrial Mapping Using Two Different Catheters Before and After Pulsed Field Ablation for Atrial Fibrillation' on Oct. 23.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - St. Marianna University School of Medicine

Condition: Condition - Atrial fibrillation Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to compare left atrial and pulmonary vein mapping performed using the FARAWAVE catheter with mapping performed using the IntellaMap Orion catheter in patients undergoing pulsed field ablation (PFA) for atrial fibrillation (AF) with the OPAL HDx/FARAVIEW system.

Agreement between the independently reconstructed left atrial geometries and bipolar voltage maps obtained using the two catheters will be assessed before and after PFA, focusing on bipolar voltage distribution, left atrial geometry volume, low-voltage area, and other mapping-derived parameters. The study will explore whether FARAWAVE-based mapping could serve as an alternative to IntellaMap Orion-based mapping. In particular, agreement between the two mapping methods will be evaluated regarding anatomical information and voltage distribution relevant to pre-PFA treatment planning, as well as information relevant to assessing treatment effects and procedural endpoints after PFA. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - In addition to standard-of-care left atrial and pulmonary vein Pre-mapping and Post-mapping using the IntellaMap Orion catheter, additional Pre-mapping and Post-mapping using the FARAWAVE catheter will be performed for research purposes.

Both mapping procedures will be performed using the OPAL HDx/FARAVIEW system, with independent reconstruction of left atrial geometry and bipolar voltage maps for each catheter. Pre-mapping will be performed before PFA, and Post-mapping will be performed after completion of the initial PFA treatment and before any additional ablation.

The acquired mapping data will be used to compare bipolar voltage distribution and quantitative mapping parameters, including left atrial geometry volume, posterior wall surface area, and low-voltage area and its proportion. PFA treatment itself will be performed as part of standard clinical care.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients who meet all of the following criteria will be eligible:

1. Patients diagnosed with atrial fibrillation (AF) by a standard 12-lead electrocardiogram or Holter electrocardiographic monitoring.

2. Patients aged 18 years or older, with no upper age limit or sex restriction.

3. Patients considered eligible by their treating cardiologist, in accordance with the relevant Japanese Circulation Society/Japanese Heart Rhythm Society guidelines, for pulmonary vein isolation, left atrial posterior wall isolation, or both, using pulsed field ablation (PFA) with the OPAL HDx/FARAVIEW and FARAPULSE systems.

4. Patients who have provided informed consent for catheter ablation and for participation in this study, either personally or through a legally authorized representative, as appropriate. Key exclusion criteria - Patients for whom appropriate informed consent for participation in this study cannot be obtained from the patient or a legally authorized representative. Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 10 Month 23 Day Anticipated trial start date - 2026 Year 11 Month 01 Day Last follow-up date - 2027 Year 10 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072440

Disclaimer: Curated by HT Syndication.