Workflow Optimization During Pulse Field Ablation for Atrial Fibrillation

NCT07354217 | Not Yet Recruiting Phase 4

• 1 other identifier: 202512001MIPA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pulsed Field Ablation; Lidocaine

Keywords

Pulmonary Vein Isolation; LIDOCAINE; Pulse Field Ablation; cough suppression

Outcome Measures

Primary Outcomes (1)

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

  The reduction of diaphragm contraction and dry cough frequency and intensity; 1. the diaphragm movement distance during ablation, evaluated with intracardiac echocardiography (ICE); 2. 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;

  400 days

Secondary Outcomes (2)

• Acute effect (per vein)

  400DAYS

• Chronic effect

  400DAYS

Study Arms (2)

LIDOCAINE

EXPERIMENTAL

Lidocaine 1 mg/kg

Drug: lidocaine

Saline

ACTIVE COMPARATOR

Saline 3\~5ml

Drug: Saline

Interventions

lidocaine DRUG

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

LIDOCAINE

Saline DRUG

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

Saline

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Johnson & Johnson: collaborator

Study Sites (1)

National Taiwan University Hospita

Taipei, 100, Taiwan

Location

MeSH Terms

Interventions

Lidocaine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Chih-Chieh Yu, MD.PhD

CONTACT

0972652038; sweetchieh@gmail.com

HSIAO-HAN HUANG

CONTACT

0932917553; clrhuang8853@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Aims: To evaluate the efficacy and safety of intravenous lidocaine during PFA ablation for diaphragm contraction and cough suppression.

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 21, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

TW (1)