Workflow Optimization During Pulse Field Ablation for Atrial Fibrillation
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- To evaluate the efficacy and safety of intravenous lidocaine during PFA ablation for diaphragm contraction and cough suppression.
Study Overview
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
LIDOCAINE
Lidocaine 1 mg/kg
Intervention: lidocaine (Drug)
Saline
Saline 3~5ml
Intervention: Saline (Drug)
Outcomes
Primary Outcomes
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; 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;
Secondary Outcomes
- Acute effect (per vein)(400DAYS)
- Chronic effect(400DAYS)