Lidocaine, Pulsed Field Ablation
Conditions
Keywords
Pulmonary Vein Isolation, LIDOCAINE, Pulse Field Ablation, cough suppression
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.
Interventions
DRUGlidocaine
baseline SaO2, heart rate, and systolic and diastolic blood pressure will be recorded before and every 10 minutes after drug injection
DRUGSaline
baseline SaO2, heart rate, and systolic and diastolic blood pressure will be recorded before and every 10 minutes after drug injection
Sponsors
National Taiwan University Hospital
Johnson & Johnson
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Aims: To evaluate the efficacy and safety of intravenous lidocaine during PFA ablation for diaphragm contraction and cough suppression.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the efficacy and safety of intravenous lidocaine during PFA ablation for diaphragm contraction and cough suppression. | 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
| Measure | Time frame | Description |
|---|---|---|
| Acute effect (per vein) | 400DAYS | 1. the number of ablations that has to be terminated prematurely; 2. the extra number of ablations that has to be applied to achieve entry block; 3. the need to remap (3D electroanatomical map shifting); |
| Chronic effect | 400DAYS | The AF recurrence rate within 1 year after the index procedure. |
Countries
Taiwan
Contacts
CONTACTChih-Chieh Yu, MD.PhD
CONTACTHSIAO-HAN HUANG
Outcome results
None listed