Tokyo, Nov. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059700) titled 'Local Activation Time Velocity Vector-Guided Target Localization and First-site Success in Typical Atrioventricular Nodal Reentrant Tachycardia Cryoablation: A Prospective Study' on Nov. 8.

Study Type: Interventional

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

Primary Sponsor: Institute - Gifu Prefectural General Medical Center

Condition: Condition - Typical atrioventricular nodal reentrant tachycardia Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To clarify the proportion of cases in which noninducibility of typical atrioventricular nodal reentrant tachycardia is achieved within the target region (LVV hot-spot) identified using Local Activation Time Velocity Vectors (LVV), referred to as the first-site success rate. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Cryoablation will be performed for typical atrioventricular nodal reentrant tachycardia guided by local activation time velocity vector analysis using the CARTO3 system.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Participants who meet all of the following conditions will be enrolled: 1.Age 18 years or older. 2.Patients diagnosed with typical atrioventricular nodal reentrant tachycardia (slow-fast type) based on clinical findings and electrophysiological study. 3.Patients scheduled to undergo cryoablation with target localization guided by Local Activation Time Velocity Vector (LVV) analysis using the CARTO3 three-dimensional mapping system. 4.Patients who have received a full explanation of the study purpose and methods and have provided written informed consent. 5.Patients expected to be available for outpatient follow-up at 3 months after the procedure. Key exclusion criteria - Participants meeting any of the following conditions will be excluded: 1.History of previous ablation for atrioventricular nodal reentrant tachycardia (AVNRT). 2.Patients whose primary arrhythmia mechanism is a manifest accessory pathway (for example, overt atrioventricular reentrant tachycardia). 3.Cases in which Kochs triangle cannot be adequately identified, making proper LVV analysis or target localization unfeasible. 4.Patients with severe atrioventricular conduction disturbance or marked bradycardia, in whom the investigator judges that study participation would compromise safety. 5.Pregnant women or those with a high likelihood of pregnancy. 6.Patients with serious comorbidities (for example, active infection or uncontrolled heart failure) that make study participation inappropriate in the judgment of the investigator. 7.Patients who are unable or unwilling to provide written informed consent, or who subsequently withdraw consent. Target Size - 30

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 11 Month 08 Day Date of IRB - 2025 Year 11 Month 05 Day Anticipated trial start date - 2025 Year 11 Month 08 Day Last follow-up date - 2027 Year 04 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068216

Disclaimer: Curated by HT Syndication.