Pulsed Field Ablation for Atrial Fibrillation Under General Anesthesia Versus Remimazolam-based Deep Sedation
Atrial Fibrillation (AF)
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 200 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
Real-world evidence indicates that deep sedation is the predominant anesthesia strategy for pulsed field ablation (PFA) in most European centers, whereas general anesthesia remains the standard of care in China. Given disparities in anesthesiologist availability and fundamental differences in healthcare system infrastructure and workflow organization, establishing an electrophysiologist-led deep sedation pathway has the potential to streamline PFA procedural logistics, enhance perioperative patient comfort, and facilitate the standardized, scalable, and sustainable implementation of this novel technology. This study aims to determine whether pulmonary vein isolation (PVI) performed with PFA under a remimazolam-based deep sedation protocol is non-inferior to PVI under general anesthesia in terms of both safety and efficacy among patients with atrial fibrillation (AF).
Read the full description
Eligible patients with atrial fibrillation (AF) will be randomly assigned in a 1:1 ratio, stratified by AF type (paroxysmal vs. persistent), to either the general anesthesia group (GA group) or the deep sedation group (DS group). All participants will undergo bilateral pulmonary vein isolation (PVI) using a pulsed field ablation (PFA) catheter; additional ablation beyond PVI will be performed at the operator's discretion based on procedural assessment.
Patients in the GA group will receive general anesthesia per institutional standard of care. Patients in the DS group will receive remimazolam-fentanyl-based deep sedation according to a standardized protocol.
Intraoperative monitoring will include continuous 12-lead electrocardiography (ECG), pulse oximetry (SpO₂), and noninvasive arterial blood pressure measurement-at minimum.
All participants will undergo a scheduled follow-up visit at 2 months post-procedure.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
1. At the time of enrollment, the legal age is ≥ 18 years old;
2. Patients with non-valvular atrial fibrillation who have indications for atrial fibrillation ablation;
3. Intend to receive atrial fibrillation ablation for the first time;
4. Able to provide informed consent, willing to participate in follow-up visits and provide relevant information.
Exclusion Criteria:
1. Secondary atrial fibrillation due to electrolyte imbalance or other reversible or non-cardiac causes;
2. Contraindications to PFA procedure, anticoagulant drugs or anesthetic drugs;
3. Acute myocardial infarction or stroke within 3 months;
4. Heart Failure subjects with NYHA III/IV or LVEF \< 40%;
5. BMI ≥ 35 kg/m²;
6. Sleep apnea syndrome, or anticipated airway difficulty;
7. COPD GOLD III/IV grade, severe asthma and other respiratory diseases;
8. Clinical conditions assessed by the investigator as unsuitable for deep sedation, such as high reflux and high aspiration risk;
9. Clinical conditions assessed by the investigator as intolerant to the procedure, such as severe liver and kidney dysfunction.
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- No masking
General Anesthesia
Subjects in this arm will accept PFA procedure under general anesthesia .
Procedure: General Aneasthesia
Deep Sedation
Subjects in this arm will accept PFA procedure under deep sedation using the protocol of remimazolam and fentanyl.
Procedure: Deep sedation
Deep sedation PROCEDURE
For induction period, remimazolam will be administered as a slow intravenous bolus followed by fentanyl via intravenous injection. For maintenance period, continuous intravenous infusions of remimazolam and fentanyl will be applied. Dosages will be titrated dynamically based on real-time monitoring of the blood pressure to maintain hemodynamic stability. Prior to the first application, a bolus of fentanyl and remimazolam will be administered.
General Aneasthesia PROCEDURE
Subjects will accept PFA procedure under general anesthesia under standard of care.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Incidence of the composite failure events, including clinical hypoxemia, clinical hypotension, and anesthesia failure.
Time frame: During the index procedure
1. Anesthesia failure is defined as intolerance to the randomly assigned anesthetic regimen during the procedure, requiring a switch to an alternative anesthetic approach to ensure procedural success.
2. Clinical hypoxemia is defined as oxygen saturation \< 85% lasting for 1 minute or the need for clinical intervention (increased fraction of inspired oxygen, airway management, or drug administration) or resulting in procedure discontinuation.
3. Clinical hypotension is defined as systolic blood pressure \< 85 mmHg lasting for at least 1 minute or the need for pharmacological intervention or resulting in procedure discontinuation
Secondary measures
The incidences of anesthesia-related adverse events (e.g., vomiting, dry cough, cognitive dysfunction, airway injury).
Time frame: During the index procedure
Not reported in this registry record.
Early recurrence rate at 2 months
Time frame: 60 days
Defined as the proportion of subjects with documented atrial arrhythmias lasting ≥30s within 60 days
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (0)
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No locations are listed. Use the official study contact.
Study team and timeline
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Study start
- Nov 30, 2026 Estimated
- Primary completion
- Nov 30, 2027 Estimated
- Study completion
- Feb 28, 2028 Estimated
- First posted
- Nov 10, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
A Randomized Controlled Study on the Efficacy of Pulsed Field Ablation for Atrial Fibrillation Under General Anesthesia Versus Remimazolam-based Deep Sedation
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026