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

NCT07541339 | Not Yet Recruiting DMC

• 1 other identifier: (2026) Kelunshen No.1
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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.
3. 3.Receive the assigned anesthetic strategy combined with standardized PFA procedure
4. 4.Complete intraoperative vital sign and related index monitoring
5. 5.Undergo follow-up visits at 12-24 hours, 30 days and 90 days after surgery for relevant index assessment and adverse event recording

Conditions

Atrial Fibrillation (Paroxysmal)

Keywords

Paroxysmal atrial fibrillation; Pulsed-field ablation; Conscious sedation; General anesthesia; Efficacy; Safety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Individual components of the primary composite endpoint

  During procedure

• The number of occurrences of each component of the primary outcome

  During procedure

• Sedation difficulty score

  During procedure

• Total procedure time

  During procedure

• Left atrial dwell time

  During procedure

Study Arms (2)

conscious sedation group

EXPERIMENTAL

A conscious sedation regimen based on remimazolam combined with fentanyl, plus lidocaine for antitussive therapy, administered by electrophysiologists.

Procedure: conscious sedation

General anesthesia group

ACTIVE COMPARATOR

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)

Interventions

conscious sedation PROCEDURE

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.

conscious sedation group

General Anesthesia (control group) PROCEDURE

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.

Also known as: general anesthesia

General anesthesia group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Conscious Sedation; Anesthesia, General; Control Groups

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Anesthesia; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ning Zhou

  Beijing Anzhen Hospital

  STUDY CHAIR

Central Study Contacts

Ning Zhou, MD and PhD

CONTACT

86+13910526308; zn075@163.com

SiTong Li, MD

CONTACT

86+17888810926; moonli1996@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: April 21, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)