Workflow Optimization During Pulse Field Ablation for Atrial Fibrillation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: lidocaine, Saline.
- Who it may be relevant to
- Registry conditions: Pulsed Field Ablation, Lidocaine. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Drug lidocaine
baseline SaO2, heart rate, and systolic and diastolic blood pressure will be recorded before and every 10 minutes after drug injection - Drug Saline
baseline SaO2, heart rate, and systolic and diastolic blood pressure will be recorded before and every 10 minutes after drug injection
Primary outcome measures
- To evaluate the efficacy and safety of intravenous lidocaine during PFA ablation for diaphragm contraction and cough suppression. [Time frame: 400 days]
Secondary outcome measures (2)
- Acute effect (per vein) [Time frame: 400DAYS]
- Chronic effect [Time frame: 400DAYS]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
Taiwan · 1 center
- National Taiwan University Hospita — Taipei
Identifiers
NCT: NCT07354217 · 202512001MIPA