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Not yet recruiting Phase 4 NCT07354217

Workflow Optimization During Pulse Field Ablation for Atrial Fibrillation

Phase 4 – monitoring after market approval
Conditions: Pulsed Field Ablation Lidocaine

Sponsor: National Taiwan University Hospital

trial.available_in: БГ
Overview
To evaluate the efficacy and safety of intravenous lidocaine in reducing diaphragmatic contraction and suppressing the cough reflex during pulsed field ablation procedures.
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.
Who can participate
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
Interventions
lidocaine
DRUG
Saline
DRUG
Locations 1
Taiwan (1)
National Taiwan University Hospita
Taipei
Technical details
Status
Not yet recruiting
Phase
Phase 4
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.06.2026
Completion date
31.12.2030
Registry ID
NCT07354217
Source
clinicaltrials.gov
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