NCT07541339Active, not recruiting
Safety and Efficacy of Conscious Sedation Versus General Anesthesia in Pulsed-Field Ablation for Paroxysmal Atrial Fibrillation
Safety and Efficacy of Conscious Sedation Versus General Anesthesia in Pulsed-Field Ablation for Paroxysmal Atrial Fibrillation: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 224 (estimated)
- First submitted
- 19 Mar 2026
- Start date
- 1 Apr 2026
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- Beijing Anzhen Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT07541339
What you commit to
- Study type: Interventional
- Planned participants: 224
- From 1 Apr 2026 to the primary completion date, 1 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent participation in other interventional clinical trials
Other illness
- Obstructive sleep apnea-hypopnea syndrome (OSAHS)
- Complicated with severe chronic obstructive pulmonary disease (COPD), asthma or other respiratory system diseases
- Acute coronary syndrome within 3 months
- Within 3 months after percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG) or other cardiac/vascular surgeries
- Acute cerebrovascular disease within 1 month
- Severe hepatic insufficiency (Child-Pugh Class C)
- History of chronic heavy alcohol consumption
- History of substance abuse
- Hypersensitivity to any medications used in the study protocol
- Other conditions deemed unsuitable for study participation by the investigators
Lab values
- Current left ventricular ejection fraction (LVEF) ≤40% or New York Heart Association (NYHA) functional class Ⅲ-Ⅳ
- Estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73m² or on dialysis
Other
- 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)
- Moderate/severe stenosis or severe regurgitation of aortic or mitral valve
- Pregnancy or lactation
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Anzhen Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.