Circumferential Pulmonary Vein Isolation Plus Transition Zone Modification in Atrial Fibrillation Patients Without Low-Voltage Areas

Not Applicable

Not yet recruiting

• Conditions: Atrial Fibrillation (AF)

• Registration Number: NCT06930599
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

This study investigates two treatments for atrial fibrillation (AF) patients without low-voltage-areas (LVAs). It aims to determine whether adding transition zone modification (TZM) to the pulmonary vein isolation (PVI) improves long-term outcomes compared to PVI alone.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-04-09
• Study First Submitted: 2025-04-09
• Study First Submitted QC: 2025-04-09
• Last Update Submitted: 2025-04-09
• Study First Posted: 2025-04-16
• Last Update Posted: 2025-04-16
• Primary Completion: 2026-10-09
• Study Completion: 2026-10-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

Aged 18 to 80 years AF referring for ablation No prior history of AF Absence of low-voltage areas during substrate mapping Presence of transition zone during substrate mapping Sign informed consent

Exclusion Criteria

Presence of left atrial thrombus Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within three months prior to enrollment Previous cardiac transplantation, complex congenital heart disease, rheumatic heart disease Untreated hypothyroidism or hyperthyroidism Dialysis-dependent terminal renal failure Life expectancy <12 months due to non-cardiovascular causes. Any conditions that, in the opinion of the investigator, may render the patient unable to complete the study Female under pregnancy or breast-feeding Involved in other studies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Freedom From AF and/or ATs With or Without Antiarrhythmic Drugs (AADs)	at least 12 months follow up	Freedom from AF and/or ATs with or without antiarrhythmic drugs (AADs) at 12months after a single-ablation procedure. AF and/or AT occurring in the first 3 months after the ablation (blanking period) was censored. Each episode lasts \> 30 seconds.

Secondary Outcome Measures

Name	Time	Method
Incidence of Peri-procedural Complications	1 week after patient enrollment	Incidence of Peri-procedural Complications：stroke, cardiac perforation, PV stenosis, esophageal injury and death
Total procedure time	1 week after patient enrollment	time that the patient spend in the procedure room
Total fluoroscopic time	1 week after patient enrollment	the total fluoroscopy time, during PVI alone or PVI plus low-voltage substrate modification
Total RF delivery time	1 week after patient enrollment	The cumulative duration (in minutes) of active radiofrequency (RF) energy application to the atrial tissue during the ablation procedure.