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Workflow Optimization During Pulse Field Ablation for Atrial Fibrillation

ConditionsPulsed Field AblationLidocaine
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Taiwan University Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • lidocaine

    Drug

    baseline SaO2, heart rate, and systolic and diastolic blood pressure will be recorded before and every 10 minutes after drug injection

  • Saline

    Drug

    baseline SaO2, heart rate, and systolic and diastolic blood pressure will be recorded before and every 10 minutes after drug injection

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: LIDOCAINEExperimental treatment 1 intervention
Group B: SalineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

To evaluate the efficacy and safety of intravenous lidocaine during PFA ablation for diaphragm contraction and cough suppression.

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;

Time frame
400 days

Secondary outcomes

1

Acute effect (per vein)

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);

Time frame
400DAYS
2

Chronic effect

The AF recurrence rate within 1 year after the index procedure.

Time frame
400DAYS

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Taiwan University Hospital

Lead sponsor

Johnson & Johnson

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: