Tokyo, Oct. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063393) titled 'Changes in Local Impedance 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 and typical atrial flutter Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to evaluate changes in local impedance (LI) before and after pulsed field ablation (PFA) using FARAWAVE and the OPAL HDx/FARAVIEW mapping system for pulmonary vein isolation in patients with atrial fibrillation who also undergo cavotricuspid isthmus (CTI) ablation using the IntellaNav STABLEPOINT catheter for typical atrial flutter.

LI changes will be assessed at the pulmonary vein antra and non-ablated atrial regions. The associations between LI changes, effective lesion formation, and successful pulmonary vein isolation will also be investigated. Additionally, the incidence of unintended superior vena cava isolation and its association with LI reduction in the superior vena cava will be explored. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - As part of standard clinical care, patients will undergo pulmonary vein isolation using pulsed field ablation (PFA) with FARAWAVE for atrial fibrillation and cavotricuspid isthmus (CTI) ablation using IntellaNav STABLEPOINT for typical atrial flutter.

As study specific interventions beyond standard clinical care, additional three-dimensional mapping of the right atrium and superior vena cava will be performed using IntellaMap Orion, and local impedance (LI) measurements will be obtained using IntellaNav STABLEPOINT.

LI will be measured before and after PFA at 22 predefined sites in the pulmonary vein and left atrial regions and at two predefined sites in the superior vena cava. Measurement sites will be tagged on the three-dimensional mapping system to enable assessment at corresponding locations before and after ablation.

LI measurements will be performed with a contact force of 5 to 10 g, aiming to maintain a difference of no more than 2 g between pre and post ablation measurements. Catheter orientation and cardiac rhythm conditions will be kept as consistent as possible. LI values will be acquired without being visible to the operator.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients diagnosed with both atrial fibrillation (AF) and atrial flutter (AFL) by 12 lead electrocardiography or Holter electrocardiography. 2. Patients considered appropriate by the treating physician, in accordance with the relevant Japanese clinical practice guidelines, for pulmonary vein isolation using the FARAPULSE pulsed field ablation (PFA) system with OPAL HDx/FARAVIEW mapping and cavotricuspid isthmus (CTI) ablation using IntellaNav STABLEPOINT. 3. Patients aged 18 years or older, with no upper age limit or sex restriction. 4. Patients for whom appropriate informed consent for study participation has been obtained from the patient or a legally authorized representative. Key exclusion criteria - Patients for whom informed consent for study participation 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 10 Day Last follow-up date - 2028 Year 07 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072485

Disclaimer: Curated by HT Syndication.