An interventional study of Deep sedation and General Aneasthesia in Atrial Fibrillation (AF), sponsored by China National Center for Cardiovascular Diseases. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by China National Center for Cardiovascular Diseases · Not applicable, Interventional, and Treatment
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).
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.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 200 is above the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →China National Center for Cardiovascular Diseases is the lead sponsor of 269 studies on the registry; 141 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects in this arm will accept PFA procedure under general anesthesia .
Procedure: General Aneasthesia
Subjects in this arm will accept PFA procedure under deep sedation using the protocol of remimazolam and fentanyl.
Procedure: Deep sedation
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.
Subjects will accept PFA procedure under general anesthesia under standard of care.
Incidence of the composite failure events, including clinical hypoxemia, clinical hypotension, and anesthesia failure.
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
Time frame: During the index procedure
The incidences of anesthesia-related adverse events (e.g., vomiting, dry cough, cognitive dysfunction, airway injury).
Time frame: During the index procedure
Early recurrence rate at 2 months
Defined as the proportion of subjects with documented atrial arrhythmias lasting ≥30s within 60 days
Time frame: 60 days
No study locations are listed for this record.
Start is estimated for Nov 2026; primary completion for Nov 2027, 12 months later.
Of 796 non-industry interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's planned 12 months is below that.
Counting every sponsor, half of 1,051 studies reached it within 33 months; a quarter within 18 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
China National Center for Cardiovascular Diseases →