Safety and Efficacy of Conscious Sedation Versus General Anesthesia in Pulsed-Field Ablation for … (NCT07541339) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Safety and Efficacy of Conscious Sedation Versus General Anesthesia in Pulsed-Field Ablation for Paroxysmal Atrial Fibrillation
China224 participantsStarted 2026-04-01
Plain-language 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. 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
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 particip…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.