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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation (Paroxysmal)
• Intervention / Treatment: Procedure: conscious sedation; Procedure: General Anesthesia (control group)

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.

• Study Type: Interventional
• Enrollment (Estimated): 224
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ning Zhou, MD and PhD; Phone Number: 86+13910526308; Email: zn075@163.com
• Study Contact Backup: Name: SiTong Li, MD; Phone Number: 86+17888810926; Email: moonli1996@163.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100029
      • Beijing Anzhen Hospital
      • Contact: Sitong Li, MD; Phone Number: 86+13910526308; Email: moonli1996@163.com
      • Principal Investigator: Wanting Qin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: conscious sedation group; A conscious sedation regimen based on remimazolam combined with fentanyl, plus lidocaine for antitussive therapy, administered by electrophysiologists.	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 solution with a concentration of 0.01 mg/mL. Dose reduction and slower injection rate are required for patients with hepatic/renal insufficiency, obesity, or elderly/weak conditions.
Active Comparator: General anesthesia group; The general anesthesia group adopted a standardized general anesthesia process of remimazolam + sufentanil + rocuronium for anesthesia induction, and remimazolam + remifentanil for anesthesia maintenance.	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. Anesthesia was maintained with continuous intravenous ciprofol (0.4-1 mg/kg/h) and remifentanil (0.1-0.2 μg/kg/min) to keep BIS 60-80 and MAP >70 mmHg, with vasoactive agents as needed. Anesthetics were discontinued before surgery end; the laryngeal mask airway was removed after the patient regained consciousness with satisfactory spontaneous breathing, and antagonistic drugs were used if necessary.; Other Names: general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary outcome	persistent systolic blood pressure <85 mmHg for more than 60 seconds, or persistent hypoxemia (SpO₂ <85%) for more than 60 seconds.	During procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluoroscopy time	Fluoroscopy time	During procedure
Individual components of the primary composite endpoint	persistent systolic blood pressure <85 mmHg for more than 60 seconds, or persistent hypoxemia (SpO₂ <85%) for more than 60 seconds.	During procedure
The number of occurrences of each component of the primary outcome	The number of occurrences of each component of the primary outcome: (1) Systolic blood pressure persistently below 85 mmHg for more than 60 sec; or (2) Persistent hypoxemia (SpO₂ < 85%) for more than 60 seconds.	During procedure
Sedation difficulty score	1-10; 1 = easiest, 10 = most difficult	During procedure
Total procedure time	from femoral vein puncture to sheath removal	During procedure
Left atrial dwell time	The duration that the catheter stays in the left atrium	During procedure
Total number of ablations	The total number of ablation discharges	During procedure
Total ablation duration	The total ablation discharge time	During procedure
Radiation dose	Radiation dose	During procedure
Acute pulmonary vein isolation rate	Acute pulmonary vein isolation rate	During procedure
Arterial PaCO₂ immediately before discontinuation of sedation/anesthesia	Arterial PaCO₂ immediately before discontinuation of sedation/anesthesia	During procedure
Operative Sedation Assessment Scale	Please ask the patient to recall how much pain they felt during the surgery?（0-10, the higher the score, the more severe the pain）	12-24 hours postoperatively
Atrial fibrillation recurrence at 30 days post-procedure	Atrial fibrillation recurrence at 30 days post-procedure	Day30
Atrial fibrillation recurrence at 90 days post-procedure	Atrial fibrillation recurrence at 90 days post-procedure	Day90
Atrial fibrillation burden at 90 days post-procedure	Use 3 days of electrocardiogram patch monitoring to assess the burden of atrial fibrillation（Atrial fibrillation burden (%) = Total duration of atrial fibrillation ÷ Effective monitoring duration × 100%）	Day90
Serious adverse events	SAE refers to adverse reactions that meet any of the following criteria: Death or life-threatening; Resulting in severe and permanent disability; Requiring hospitalization or prolonging hospital stay; Causing congenital abnormalities or birth defects in offspring; A significant medical event determined by the researcher to cause major harm or injury to the subject, which may require drug treatment or surgical intervention to prevent the occurrence of other conditions as defined by SAE (such as death, permanent disability, hospitalization, etc.).	Day0-90

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital
• Investigators: Study Chair: Ning Zhou, Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: March 19, 2026
• First Submitted That Met QC Criteria: April 14, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Paroxysmal atrial fibrillation; General anesthesia; Conscious sedation; Pulsed-field ablation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Anesthesia and Analgesia; Anesthesia; Control Groups; Anesthesia, General; Conscious Sedation
• Other Study ID Numbers: (2026) Kelunshen No.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No