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NCT Number: NCT06930599

Circumferential Pulmonary Vein Isolation Plus Transition 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.

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Freedom From AF and/or ATs With or Without Antiarrhythmic Drugs (AADs)

    Time frame: 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 outcomes

  1. Incidence of Peri-procedural Complications

    Time frame: 1 week after patient enrollment

    Incidence of Peri-procedural Complications：stroke, cardiac perforation, PV stenosis, esophageal injury and death

  2. Total procedure time

    Time frame: 1 week after patient enrollment

    time that the patient spend in the procedure room

  3. Total fluoroscopic time

    Time frame: 1 week after patient enrollment

    the total fluoroscopy time, during PVI alone or PVI plus low-voltage substrate modification

  4. Total RF delivery time

    Time frame: 1 week after patient enrollment

    The cumulative duration (in minutes) of active radiofrequency (RF) energy application to the atrial tissue during the ablation procedure.

Study contacts

Contact information is provided by the study sponsor or research team.

Hongwu Chen, M.D.

CONTACT

[email protected]

+86-15996291298

Yue Qiu, M.D.

CONTACT

[email protected]

+86-13057657758

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

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

Acronym: PVI-TZM-AF

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2025
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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