Deep Sedation vs. General Anesthesia for Pulsed Field Ablation in Atrial Fibrillation (SAFE-PFA)

May 31, 2026 updated by: Second Affiliated Hospital of Nanchang University

A Study on the Safety and Efficacy of Deep Sedation With Dexmedetomidine Combined With Remimazolam and Remifentanil Versus General Anaesthesia for Radiofrequency Ablation of Atrial Fibrillation

  1. Research Title: A Study on the Safety and Efficacy of Deep Sedation With Dexmedetomidine Combined With Remimazolam and Remifentanil Versus General Anaesthesia for Radiofrequency Ablation of Atrial Fibrillation
  2. Research Objective: The aim of this study is to compare the safety and efficacy of deep sedation using a combination of dexmedetomidine and remimazolam versus remifentanil, and general anaesthesia, in patients undergoing pulsed electric field ablation for atrial fibrillation. Through this study, we hope to optimise the management of the perioperative period for atrial fibrillation pulse field ablation and develop a carefully designed deep sedation protocol based on modern pharmacology. This protocol will maximise patient comfort, facilitate the surgeon's procedure, and enhance the efficiency of overall healthcare resource utilisation, whilst ensuring surgical success and patient safety. Consequently, it will provide crucial anaesthetic support for the standardisation and widespread adoption of atrial fibrillation pulse field ablation technology.
  3. Study Design: Interventional clinical study
  4. Study Subjects: Patients with atrial fibrillation scheduled for catheter ablation at the Second Affiliated Hospital of Nanchang University between January 2026 and January 2027.
  5. Sample Size: N=80 patients, randomly assigned using a computer-generated random number table to the deep sedation group (n=40) or general anesthesia group (n=40) at a 1:1 ratio.

  6. Inclusion and Exclusion Criteria:

    Inclusion Criteria: ① Age 18-75 years (inclusive); ② Clinically diagnosed with atrial fibrillation, indicated for pulse field ablation, and scheduled for catheter ablation; ③ Voluntarily agrees to participate in the trial and has signed informed consent; ④ Willing to comply with the trial requirements and complete the required follow-up.

    Exclusion Criteria: ① Left atrial diameter > 55 mm; ② Transesophageal echocardiography indicates a thrombus in the left atrium; ③ Contraindications to anticoagulation

  7. Observational Indicators:(1) Baseline Data: Age, sex, BMI, type of atrial fibrillation, CHA2DS2-VASc score, hemoglobin, left atrial diameter, ejection fraction, and the prevalence of diabetes, hypertension, congestive heart failure, stroke/TIA, coronary heart disease and renal impairment.(2) Surgical Data: Duration of interventional procedures, X-ray exposure, operating theatre occupancy time, success rate of acute PVI, calibration deviation rate, incidence of hypoxemia and hypotension, Numerical Rating Scale (NRS) scores for pain, and postoperative complications.
  8. Statistical Analysis: Data analysis was performed using IBM SPSS Statistics 26.0 software; continuous variables following a normal distribution are expressed as mean ± standard deviation, and comparisons between two independent samples were performed using t-tests; categorical variables are presented as frequencies and percentages, and comparisons were performed using chi-square tests; a two-sided P-value of <0.05 was considered statistically significant.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The Second Affiliated Hospital of Nanchang University
        • Contact:
          • Qi Chen, MD, PhD
          • Phone Number: +86-13330087688
          • Email: efycq@189.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 to 75 years, inclusive
  • Clinically diagnosed atrial fibrillation
  • Indicated for pulsed field ablation and scheduled for pulsed field ablation catheter procedure
  • Able and willing to provide written informed consent
  • Willing to comply with study procedures and follow-up requirements

Exclusion Criteria:

  • Left atrial diameter >55 mm
  • Presence of left atrial thrombus detected by transesophageal echocardiography
  • Contraindications to anticoagulation therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Deep Sedation Group
Patients undergoing atrial fibrillation pulsed field ablation under a novel deep sedation protocol
Procedure: Standardized Deep Sedation Protocol
A deep sedation protocol using dexmedetomidine, remifentanil and remazolam for atrial fibrillation pulse field ablation
Placebo Comparator: General Anesthesia Group
Patients undergoing atrial fibrillation pulsed field ablation under general anesthesia
Procedure: Standard General Anesthesia
Atrial fibrillation pulse filed ablation using a standard endotracheal intubation general anaesthesia protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operating Room Occupancy Time
Time Frame: From Operating Room entry to Operating Room exit
The duration from the patient's entry into the operating room to their departure from the room. This includes anesthetic induction, the surgical procedure, and emergence/extubation.
From Operating Room entry to Operating Room exit
Net Procedure Duration
Time Frame: During the procedure
Defined as the time from the first skin puncture for vascular access to the removal of the last catheter.
During the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative Recovery Time
Time Frame: From procedure completion to transfer to the general ward, assessed up to 24 hours post-procedure
The time interval from the end of the procedure until the patient meets the criteria for transfer back to the general ward
From procedure completion to transfer to the general ward, assessed up to 24 hours post-procedure
Acute Pulmonary Vein Isolation (PVI) Success Rate
Time Frame: At the end of the ablation procedure
The percentage of pulmonary veins successfully isolated using pulsed field ablation (PFA) as confirmed by the electrophysiological mapping system.
At the end of the ablation procedure
Incidence of Hypoxemia
Time Frame: Periprocedural period
Percentage of patients experiencing oxygen saturation (SpO2) < 90% requiring intervention (e.g., increasing oxygen flow or airway maneuvers).
Periprocedural period
Incidence of Hypotension
Time Frame: Periprocedural period
Percentage of patients experiencing at least one episode of hypotension during the procedure. Hypotension is defined as a Systolic Blood Pressure (SBP) < 90 mmHg or a decrease of more than 20% from the baseline value, requiring clinical intervention (such as fluid bolus or administration of vasopressors like phenylephrine or ephedrine).
Periprocedural period
Patient Pain Intensity (NRS Score)
Time Frame: 2 hours and 24 hours post-operation
Patient-reported pain levels assessed using the Numerical Rating Scale (0-10, where 0 is no pain and 10 is the worst pain imaginable).
2 hours and 24 hours post-operation
Total Fluoroscopy Dose (DAP)
Time Frame: At the end of the procedure
The cumulative radiation exposure to the patient, measured as Dose Area Product (DAP) in cGy·cm².
At the end of the procedure
Incidence of Perioperative Complications
Time Frame: up to 30 days post-procedure
Occurrence of procedure-related adverse events, including cardiac tamponade, stroke/TIA, vascular access site complications (e.g., hematoma, pseudoaneurysm), phrenic nerve injury, and anesthesia-related complications.
up to 30 days post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Nanchang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 25, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

May 16, 2026

First Submitted That Met QC Criteria

May 31, 2026

First Posted (Actual)

June 2, 2026

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 31, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT-2026-026

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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