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

Официальное название

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

Обзор

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.

Вмешательства

• Процедура Standardized Deep Sedation Protocol
  A deep sedation protocol using dexmedetomidine, remifentanil and remazolam for atrial fibrillation pulse field ablation
• Процедура Standard General Anesthesia
  Atrial fibrillation pulse filed ablation using a standard endotracheal intubation general anaesthesia protocol

Первичные конечные точки

• Operating Room Occupancy Time [Срок оценки: From Operating Room entry to Operating Room exit]
• Net Procedure Duration [Срок оценки: During the procedure]

Вторичные конечные точки (7)

• Post-operative Recovery Time [Срок оценки: From procedure completion to transfer to the general ward, assessed up to 24 hours post-procedure]
• Acute Pulmonary Vein Isolation (PVI) Success Rate [Срок оценки: At the end of the ablation procedure]
• Incidence of Hypoxemia [Срок оценки: Periprocedural period]
• Incidence of Hypotension [Срок оценки: Periprocedural period]
• Patient Pain Intensity (NRS Score) [Срок оценки: 2 hours and 24 hours post-operation]
• Total Fluoroscopy Dose (DAP) [Срок оценки: At the end of the procedure]
• Incidence of Perioperative Complications [Срок оценки: up to 30 days post-procedure]

Критерии участия

Критерии включения

• Age 18 to 75 years, inclusive
• Clinically diagnosed atrial fibrillation
• Indicated for pulsed field ablation and scheduled for pulsed field ablation catheter procedure
• Able and willing to provide written informed consent
• Willing to comply with study procedures and follow-up requirements

Критерии исключения

• Left atrial diameter >55 mm
• Presence of left atrial thrombus detected by transesophageal echocardiography
• Contraindications to anticoagulation therapy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Second Affiliated Hospital of Nanchang University — Nanchang

Публикации

• Rillig A, Hirokami J, Moser F, Bordignon S, Rottner L, Shota T, My I, Urbani A, Lemoine M, Kheir J, Schenker N, Urbanek L, Govorov K, Schaack D, Obergassel J, Riess J, Ismaili D, Kirchhof P, Ouyang F, Schmidt B, Reissmann B, Chun KJ, Metzner A. General anaesthesia and deep sedation for monopolar pulsed field ablation using a lattice-tip catheter combined with a novel three-dimensional mapping syst PMID 39576055
• Sochorova V, Kunstatova V, Osmancik P, Duska F, Herman D, Waldauf P, Poviser L, Karch J, Znojilova L, Filipcova V, Hozmanova J, Vesela J, Hozman M. COOPERATIVE-PFA: A Three-Arm Randomized Controlled Trial. Circulation. 2025 Jul 22;152(3):150-159. doi: 10.1161/CIRCULATIONAHA.125.074427. Epub 2025 Apr 27. PMID 40287932

Идентификаторы

NCT: NCT07621432 · IIT-2026-026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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