Circumferential Pulmonary Vein Isolation Plus Transition Zone Modification in Atrial Fibrillation Patients Without Low-Voltage Areas (PVI-TZM-AF)

Comparison of Pulmonary Vein Isolation With and Without Transitional Zone Modification in Atrial Fibrillation Patients Without Low-Voltage Areas

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation (AF)
• Intervention / Treatment: Procedure: Pulmonary vein isolation alone; Procedure: Pulmonary vein isolation plus transition zone modification

• Study Type: Interventional
• Enrollment (Estimated): 162
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yue Qiu, M.D.; Phone Number: +86-13057657758; Email: qiuyue@njmu.edu.cn
• Study Contact Backup: Name: Hongwu Chen, M.D.; Phone Number: +86-15996291298; Email: chenhongwu@njmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Comparator: PVI-alone arm	Procedure: Pulmonary vein isolation alone; In periprocedural period, all antiarrhythmic drugs were discontinued for at least 5 half-lives and amiodarone for 2 months before the procedure. An electrophysiological study was performed after overnight fasting and mild sedated state with administration of intravenous midazolam and fentanyl. PVI should be performed under the CARTO or Ensite electroanatomic mapping system using an open-irrigated contact-force ablation catheter.
Experimental: Experimental: PVI+TZM arm	Procedure: Pulmonary vein isolation plus transition zone modification; For those who are randomized to PVI+TZM arm, additional TZM should be performed after finishing PVI ablation. PVI could be performed using open-irrigated contact-force catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom From AF and/or ATs With or Without Antiarrhythmic Drugs (AADs)	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.	at least 12 months follow up

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): April 9, 2025
• Primary Completion (Estimated): October 9, 2026
• Study Completion (Estimated): October 9, 2026

Study Registration Dates

• First Submitted: April 9, 2025
• First Submitted That Met QC Criteria: April 9, 2025
• First Posted (Actual): April 16, 2025

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 9, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Pulmonary vein isolation; Transition Zone Modification
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 2024-SR-1134

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No