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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conscious sedation group | Experimental | A conscious sedation regimen based on remimazolam combined with fentanyl, plus lidocaine for antitussive therapy, administered by electrophysiologists. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ning Zhou, MD and PhD | Contact | 86+13910526308 | zn075@163.com | |
| SiTong Li, MD | Contact | 86+17888810926 | moonli1996@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Ning Zhou | Beijing Anzhen Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital | Beijing | Beijing Municipality | 100029 | China |
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| 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. |
|
|
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 |
| Fluoroscopy time | Fluoroscopy 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:
| Day0-90 |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016292 | Conscious Sedation |
| D000768 | Anesthesia, General |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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