Conscious Sedation Versus General Anesthesia for Pulsed Field Ablation in Paroxysmal Atrial Fibrillation

Condition(s) studied

Investigational drug(s) / intervention(s)

Local Anesthesia With Conscious Sedation: Protocol-specified antitussive pretreatment is followed by local anesthesia, analgesia, and conscious sedation. Before femoral venous puncture, intravenous tropisetron hydrochloride 5 mg, dexamethasone 5 mg, lidocaine 100 mg over 10 minutes, fentanyl 50 micrograms, midazolam 2 mg, and atropine 1 mg are given. After transseptal puncture, fentanyl 50-100 micrograms is given intravenously, followed by 0.04 micrograms/kg/min infusion. Additional midazolam or fentanyl may be given according to vital signs and clinical tolerance. Conversion to general anesthesia is permitted for persistent severe coughing, pain, anxiety, or agitation interfering with catheter positioning or energy delivery; persistent respiratory depression or refractory hypoxemia; uncorrectable hemodynamic instability; or inability or unwillingness to tolerate the assigned strategy.

General Anesthesia: General anesthesia will be induced, maintained, and monitored by an anesthesiologist according to routine clinical practice at each participating center. Airway management, anesthetic medications, ventilation parameters, hemodynamic management, and post-anesthesia recovery will be documented.

VARIPULSE Pulsed Field Ablation System: All participants will undergo bilateral pulmonary vein isolation using the VARIPULSE pulsed field ablation catheter under CARTO 3 electroanatomic mapping guidance. Additional ablation of the left atrial posterior wall, superior vena cava, or other atrial substrate may be performed when clinically indicated. Bidirectional pulmonary vein isolation will be evaluated at the end of the procedure. Activated clotting time will be maintained at 350 seconds or longer during left atrial ablation.

Compound methoxyphenamine capsules: Oral antitussive pretreatment with compound methoxyphenamine capsules (Asmeton) during the 24 hours before the procedure, as specified in the protocol.

Salbutamol: Nebulized pretreatment in combination with budesonide and lidocaine within 90 minutes before the procedure, as specified in the protocol for the local anesthesia with conscious sedation arm.

Budesonide: Nebulized pretreatment in combination with salbutamol and lidocaine within 90 minutes before the procedure, as specified in the protocol for the local anesthesia with conscious sedation arm.

Lidocaine: Administered by nebulization with salbutamol and budesonide within 90 minutes before the procedure, and intravenously before femoral venous puncture, as specified in the protocol for the local anesthesia with conscious sedation arm.

Fentanyl: For the local anesthesia with conscious sedation arm: intravenous fentanyl 50 micrograms before femoral venous puncture, followed by 50 to 100 micrograms after transseptal puncture and a continuous intravenous infusion at 0.04 micrograms/kg/min. Additional doses may be administered according to vital signs, pain, and clinical tolerance, as specified in the protocol.

Midazolam: For the local anesthesia with conscious sedation arm: intravenous midazolam 2 mg before femoral venous puncture. Additional doses may be given according to vital signs and clinical response, as specified in the protocol.

Tropisetron hydrochloride: Intravenous tropisetron hydrochloride 5 mg before femoral venous puncture as part of the protocol-specified premedication regimen for the local anesthesia with conscious sedation arm.

Dexamethasone: Intravenous dexamethasone 5 mg before femoral venous puncture as part of the protocol-specified premedication regimen for the local anesthesia with conscious sedation arm.

Atropine: Intravenous atropine 1 mg before femoral venous puncture as part of the protocol-specified premedication regimen for the local anesthesia with conscious sedation arm.

Study summary

This prospective, multicenter, randomized, controlled, noninferiority trial will compare local anesthesia with conscious sedation and general anesthesia in patients undergoing pulsed field ablation for paroxysmal atrial fibrillation.

A total of 390 participants aged 18 to 80 years will be randomly assigned in a 1:1 ratio to undergo pulsed field ablation under either local anesthesia with conscious sedation or general anesthesia. Both groups will receive pulmonary vein isolation using the same pulsed field ablation strategy.

The primary outcome is recurrence of an electrocardiographically documented atrial tachyarrhythmia after an 8-week post-ablation blanking period. Recurrence is defined as atrial fibrillation, atrial flutter, or atrial tachycardia lasting at least 30 seconds through 12 months after ablation.

The study will also compare the ability of each anesthesia strategy to support successful completion of the ablation procedure, anesthesia-related and ablation-related complications, procedural efficiency, patient-reported pain and anxiety, overall procedural experience, and direct medical costs.

Eligibility

Primary outcome measure(s)

• Percentage of Participants With Recurrence of Atrial Tachyarrhythmia After the Blanking Period — From the end of the 8-week post-ablation blanking period through 12 months after the index ablation procedure
  Recurrence is defined as at least one episode of atrial fibrillation, atrial flutter, or atrial tachycardia lasting 30 seconds or longer and documented by electrocardiographic monitoring after the 8-week post-ablation blanking period. Rhythm monitoring will be performed using a wearable electrocardiographic device for at least 7 days at each scheduled follow-up. The outcome will be reported as the percentage of participants with recurrence.

Trial sites (1)

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