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NCT Number: NCT07354217

Workflow Optimization During Pulse Field Ablation for Atrial Fibrillation

To evaluate the efficacy and safety of intravenous lidocaine in reducing diaphragmatic contraction and suppressing the cough reflex during pulsed field ablation procedures.

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Key information

Conditions

Pulsed Field Ablation Lidocaine

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Taiwan University Hospita

Taipei, 100, Taiwan

About this study

Atrial fibrillation is a common arrhythmia, and pulmonary vein isolation is the main treatment. The emerging pulsed field ablation (PFA) is tissue-selective and can reduce damage to adjacent organs, but it is often accompanied by phrenic nerve stimulation and cough reflex, affecting surgical stability. Intravenous lidocaine has been shown to suppress cough and hiccups, but its effect on PFA-induced responses has not been further studied. This study uses a prospective, randomized controlled trial to evaluate the effects of lidocaine on diaphragmatic contraction and cough reflex during PFA surgery, aiming to improve surgical safety and procedural smoothness.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with paroxysmal or persistent AF and are scheduled to undergo PVI.
  • Patients who can understand the study aims and protocol and are willing to follow the protocol for one year.

Exclusion criteria

  • Informed consent could not be obtained
  • Known allergy to study drug lidocaine.
  • Presence of thrombus in the LA or LA appendage
  • Underlying significant pulmonary disease, such as asthma or COPD needing long term maintenance therapy or documented interstitial lung disease

Treatment and study plan

Lidocaine

Drug

baseline SaO2, heart rate, and systolic and diastolic blood pressure will be recorded before and every 10 minutes after drug injection

Saline

Drug

baseline SaO2, heart rate, and systolic and diastolic blood pressure will be recorded before and every 10 minutes after drug injection

Primary outcomes

  1. To evaluate the efficacy and safety of intravenous lidocaine during PFA ablation for diaphragm contraction and cough suppression.

    Time frame: 400 days

    The reduction of diaphragm contraction and dry cough frequency and intensity;

    • the diaphragm movement distance during ablation, evaluated with intracardiac echocardiography (ICE);
    • the cough frequency and intensity after energy application; cough frequency will be evaluated by a blinded technician, and cough intensity will be evaluated by both the technician and ICE;

Secondary outcomes

  1. Acute effect (per vein)

    Time frame: 400DAYS

    • the number of ablations that has to be terminated prematurely;
    • the extra number of ablations that has to be applied to achieve entry block;
    • the need to remap (3D electroanatomical map shifting);

  2. Chronic effect

    Time frame: 400DAYS

    The AF recurrence rate within 1 year after the index procedure.

Study contacts

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

Chih-Chieh Yu, MD.PhD

CONTACT

[email protected]

0972652038

HSIAO-HAN HUANG

CONTACT

[email protected]

0932917553

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • Johnson & Johnson

Registry information

Acronym: PFA_workflow

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jan 21, 2026
Registry last updated
Apr 20, 2026

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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