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

NCT06930599 | Not Yet Recruiting

• 1 other identifier: 2024-SR-1134
• Study Type: interventional
• Target: 162
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation (AF)

Keywords

Pulmonary vein isolation; Transition Zone Modification; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Incidence of Peri-procedural Complications

  1 week after patient enrollment

• Total procedure time

  1 week after patient enrollment

• Total fluoroscopic time

  1 week after patient enrollment

• Total RF delivery time

  1 week after patient enrollment

Study Arms (2)

Active Comparator: PVI-alone arm

ACTIVE COMPARATOR

Procedure: Pulmonary vein isolation alone

Experimental: PVI+TZM arm

EXPERIMENTAL

Procedure: Pulmonary vein isolation plus transition zone modification

Interventions

Pulmonary vein isolation plus transition zone modification PROCEDURE

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.

Experimental: PVI+TZM arm

Pulmonary vein isolation alone PROCEDURE

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.

Active Comparator: PVI-alone arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yue Qiu, M.D.

CONTACT

+86-13057657758; qiuyue@njmu.edu.cn

Hongwu Chen, M.D.

CONTACT

+86-15996291298; chenhongwu@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Follow-up physicians are blinded to treatment allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 16, 2025
• Study Start: April 9, 2025
• Primary Completion (Estimated): October 9, 2026
• Study Completion (Estimated): October 9, 2026
• Last Updated: April 16, 2025

Record last verified: 2025-04