Safety and Efficacy of Conscious Sedation Versus General Anesthesia in Pulsed-Field Ablation for Paroxysmal Atrial Fibrillation

Official title

Safety and Efficacy of Conscious Sedation Versus General Anesthesia in Pulsed-Field Ablation for Paroxysmal Atrial Fibrillation: A Randomized Controlled Trial

Overview

The goal of this clinical trial is to compare the safety and efficacy of conscious sedation and general anesthesia in patients with paroxysmal atrial fibrillation undergoing their first pulsed-field ablation (PFA) procedure. It will also establish a scalable conscious sedation protocol for PFA. The main questions it aims to answer are: 1. Does conscious sedation reduce the incidence of the composite safety endpoint (persistent hypotension or hypoxemia for more than 60 seconds intraoperatively) compared with general anesthesia? 2. What are the differences in perioperative indicators and adverse events between the two anesthetic strategies in PFA for paroxysmal atrial fibrillation? Researchers will randomly assign eligible patients to a conscious sedation group or a general anesthesia group at a 1:1 ratio to compare the safety and efficacy of the two anesthetic approaches. Participants will: 1. Receive the assigned anesthetic strategy combined with standardized PFA procedure 2. Complete intraoperative vital sign and related index monitoring 3. Undergo follow-up visits at 12-24 hours, 30 days and 90 days after surgery for relevant index assessment and adverse event recording

Detailed description

Atrial fibrillation (AF) is the most prevalent cardiac arrhythmia, which severely impairs patients' quality of life and is closely associated with an elevated risk of complications including thromboembolism and heart failure. Rhythm control, particularly catheter ablation, has become a cornerstone of AF management. In recent years, pulsed-field ablation (PFA) has emerged as a novel catheter ablation technique for AF. It demonstrates non-inferior ablation efficacy to conventional radiofrequency ablation, with the advantages of minimal injury to peri-myocardial tissues, high procedural efficiency and a low incidence of complications, thus serving as a promising alternative for AF catheter ablation.

Unlike radiofrequency ablation, PFA delivers high-voltage electric fields during the procedure, for which local anesthesia fails to achieve satisfactory sedation and analgesia. General anesthesia (GA) is currently the main anesthetic approach for PFA to ensure adequate intraoperative immobilization and provide stable conditions for precise procedural manipulation. However, GA has notable limitations: first, the central inhibitory effects of general anesthetics and procedural stress-induced responses are prone to cause perioperative hemodynamic instability, leading to adverse events such as hypotension and hypoxemia, which not only increase procedural risks but also exert adverse impacts on short- and long-term patient prognosis; second, GA usually requires endotracheal intubation or laryngeal mask ventilation, which may cause retropharyngeal injury and raise the risk of complications like bleeding or hematoma; third, GA incurs relatively high medical costs, further increasing the economic burden on patients.

In light of these unmet clinical needs, several observational studies have demonstrated the feasibility of deep or conscious sedation during PFA procedures. Nevertheless, sedation strategies vary across centers, and most findings are based on single-center, small-sample empirical summaries, lacking high-quality evidence from large-sample, rigorously designed randomized controlled trials (RCTs). Our team has previously explored a conscious sedation strategy in over 200 patients, and the results showed that this strategy could achieve satisfactory sedation and analgesia for PFA, significantly reduce the risk of GA-related hemodynamic instability, and yield favorable postoperative feedback from patients.

Given the sufficient evidence supporting the efficacy and safety of PFA in the treatment of paroxysmal atrial fibrillation (PAF), this study intends to conduct a single-center, 1:1 randomized, single-blind controlled trial to compare the safety and efficacy of conscious sedation and GA in PFA for PAF, aiming to provide an evidence-based basis for the selection of an optimal sedation regimen for PFA procedures.

Interventions

• Procedure conscious sedation
  Medications: Remimazolam toluenesulfonate injection (25 mg) + Fentanyl citrate injection (0.1 mg) + Lidocaine (100 mg). Administration method: Remimazolam: 2 vials mixed with 50 mL of 0.9% sodium chloride injection to prepare a solution with a concentration of 1 mg/mL. The target Bispectral Index (BIS) is 60-80, and the infusion rate of remimazolam is adjusted according to the BIS and patient responses. Fentanyl citrate: 5 vials mixed with 50 mL of 0.9% sodium chloride injection to prepare a
• Procedure General Anesthesia (control group)
  After femoral vein puncture, anesthesia induction was performed with remimazolam (0.2-0.3 mg/kg), sufentanil (0.3-0.4 μg/kg) and rocuronium (0.6 mg/kg) following standard monitoring and preoxygenation. A laryngeal mask airway was inserted upon loss of consciousness and adequate muscle relaxation, with lung-protective mechanical ventilation applied at tidal volume 6-8 mL/kg, respiratory rate 10-14 breaths/min, I:E 1:2, FiO₂ 60% and fresh gas flow 2-3 L/min to maintain PaCO₂ at 35-45 cmH₂O. Anesth

Primary outcome measures

• Primary outcome [Time frame: During procedure]

Secondary outcome measures (12)

• Individual components of the primary composite endpoint [Time frame: During procedure]
• The number of occurrences of each component of the primary outcome [Time frame: During procedure]
• Sedation difficulty score [Time frame: During procedure]
• Total procedure time [Time frame: During procedure]
• Left atrial dwell time [Time frame: During procedure]
• Total number of ablations [Time frame: During procedure]
• Total ablation duration [Time frame: During procedure]
• Fluoroscopy time [Time frame: During procedure]
• Radiation dose [Time frame: During procedure]
• Acute pulmonary vein isolation rate [Time frame: During procedure]
• Arterial PaCO₂ immediately before discontinuation of sedation/anesthesia [Time frame: During procedure]
• Operative Sedation Assessment Scale [Time frame: 12-24 hours postoperatively]

Eligibility criteria

Inclusion criteria

• Aged 18 to 80 years
• Diagnosed with paroxysmal atrial fibrillation
• No prior history of catheter ablation for atrial fibrillation/atrial flutter
• Scheduled to undergo pulsed-field ablation
• Provide written informed consent for study participation and be able to complete all scheduled follow-up assessments

Exclusion criteria

• Obstructive sleep apnea-hypopnea syndrome (OSAHS)
• Complicated with severe chronic obstructive pulmonary disease (COPD), asthma or other respiratory system diseases
• Body mass index (BMI) >30 kg/m² or <20 kg/m²
• Preoperative pulse oxygen saturation (SpO₂) <93%
• Anticipated difficult airway
• Intolerance to general anesthesia (American Society of Anesthesiologists \[ASA\] physical status ≥Ⅳ)
• Current left ventricular ejection fraction (LVEF) ≤40% or New York Heart Association (NYHA) functional class Ⅲ-Ⅳ
• Acute coronary syndrome within 3 months
• Within 3 months after percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG) or other cardiac/vascular surgeries
• Moderate/severe stenosis or severe regurgitation of aortic or mitral valve
• Acute cerebrovascular disease within 1 month
• Severe hepatic insufficiency (Child-Pugh Class C)
• Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m² or on dialysis
• History of chronic heavy alcohol consumption
• History of substance abuse
• Hypersensitivity to any medications used in the study protocol
• Pregnancy or lactation
• Concurrent participation in other interventional clinical trials
• Other conditions deemed unsuitable for study participation by the investigators

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

Treatment

Study locations

China · 1 center

• Beijing Anzhen Hospital — Beijing

Identifiers

NCT: NCT07541339 · (2026) Kelunshen No.1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗