Workflow Optimization During Pulse Field Ablation for Atrial Fibrillation (PFA_workflow)

National Taiwan University

Status and phase: Not yet enrolling; Phase 4

Conditions: Pulsed Field Ablation; Lidocaine

Treatments: Drug: Saline; Drug: lidocaine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07354217

202512001MIPA

Details and patient eligibility

About

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

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

LIDOCAINE

Experimental group

Description:

Lidocaine 1 mg/kg

Treatment:

Drug: lidocaine

Saline

Active Comparator group

Description:

Saline 3\~5ml

Treatment:

Drug: Saline