Deep Sedation vs. General Anesthesia for Pulsed Field Ablation in Atrial Fibrillation

Brief summary (registry, in English)

1. Research Title: A Study on the Safety and Efficacy of Deep Sedation With Dexmedetomidine Combined With Remimazolam and Remifentanil Versus General Anaesthesia for Radiofrequency Ablation of Atrial Fibrillation 2. Research Objective: The aim of this study is to compare the safety and efficacy of deep sedation using a combination of dexmedetomidine and remimazolam versus remifentanil, and general anaesthesia, in patients undergoing pulsed electric field ablation for atrial fibrillation. Through this study, we hope to optimise the management of the perioperative period for atrial fibrillation pulse field ablation and develop a carefully designed deep sedation protocol based on modern pharmacology. This protocol will maximise patient comfort, facilitate the surgeon's procedure, and enhance the efficiency of overall healthcare resource utilisation, whilst ensuring surgical success and patient safety. Consequently, it will provide crucial anaesthetic support for the standardisation and widespread adoption of atrial fibrillation pulse field ablation technology. 3. Study Design: Interventional clinical study 4. Study Subjects: Patients with atrial fibrillation scheduled for catheter ablation at the Second Affiliated Hospital of Nanchang University between January 2026 and January 2027. 5. Sample Size: N=80 patients, randomly assigned using a computer-generated random number table to the deep sedation group (n=40) or general anesthesia group (n=40) at a 1:1 ratio. 6. Inclusion and Exclusion Criteria: Inclusion Criteria: ① Age 18-75 years (inclusive); ② Clinically diagnosed with atrial fibrillation, indicated for pulse field ablation, and scheduled for catheter ablation; ③ Voluntarily agrees to participate in the trial and has signed informed consent; ④ Willing to comply with the trial requirements and complete the required follow-up. Exclusion Criteria: ① Left atrial diameter \> 55 mm; ② Transesophageal echocardiography indicates a thrombus in the left atrium; ③ Contraindications to anticoagulation 7. Observational Indicators:(1) Baseline Data: Age, sex, BMI, type of atrial fibrillation, CHA2DS2-VASc score, hemoglobin, left atrial diameter, ejection fraction, and the prevalence of diabetes, hypertension, congestive heart failure, stroke/TIA, coronary heart disease and renal impairment.(2) Surgical Data: Duration of interventional procedures, X-ray exposure, operating theatre occupancy time, success rate of acute PVI, calibration deviation rate, incidence of hypoxemia and hypotension, Numerical Rating Scale (NRS) scores for pain, and postoperative complications. 8. Statistical Analysis: Data analysis was performed using IBM SPSS Statistics 26.0 software; continuous variables following a normal distribution are expressed as mean ± standard deviation, and comparisons between two independent samples were performed using t-tests; categorical variables are presented as frequencies and percentages, and comparisons were performed using chi-square tests; a two-sided P-value of \<0.05 was considered statistically significant.

What you commit to

• Study type: Interventional
• Planned participants: 80
• From 25 May 2026 to the primary completion date, 30 Apr 2027
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

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Who cannot take part

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Who the study is looking for

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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