Deep Sedation vs. General Anesthesia for Pulsed Field Ablation in Atrial Fibrillation

NCT07621432 | Not Yet Recruiting DMC

• 1 other identifier: IIT-2026-026
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 3.Study Design: Interventional clinical study
4. 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. 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. 6.Inclusion and Exclusion Criteria:
7. 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. 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.

Conditions

Atrial Fibrillation (AF)

Keywords

atrial fibrillation; pulse field ablation; deep sedation; general anesthesia; Catheter ablation

Outcome Measures

Primary Outcomes (2)

• Operating Room Occupancy Time

  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

  Defined as the time from the first skin puncture for vascular access to the removal of the last catheter.

  During the procedure

Secondary Outcomes (7)

• Post-operative Recovery Time

  From procedure completion to transfer to the general ward, assessed up to 24 hours post-procedure

• Acute Pulmonary Vein Isolation (PVI) Success Rate

  At the end of the ablation procedure

• Incidence of Hypoxemia

  Periprocedural period

• Incidence of Hypotension

  Periprocedural period

• Patient Pain Intensity (NRS Score)

  2 hours and 24 hours post-operation

Study Arms (2)

Deep Sedation Group

EXPERIMENTAL

Patients undergoing atrial fibrillation pulsed field ablation under a novel deep sedation protocol

Procedure: Standardized Deep Sedation Protocol

General Anesthesia Group

PLACEBO COMPARATOR

Patients undergoing atrial fibrillation pulsed field ablation under general anesthesia

Procedure: Standard General Anesthesia

Interventions

Standardized Deep Sedation Protocol PROCEDURE

A deep sedation protocol using dexmedetomidine, remifentanil and remazolam for atrial fibrillation pulse field ablation

Deep Sedation Group

Standard General Anesthesia PROCEDURE

Atrial fibrillation pulse filed ablation using a standard endotracheal intubation general anaesthesia protocol

General Anesthesia Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Second Affiliated Hospital of Nanchang University: lead

Study Sites (1)

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

Related Publications (2)

• Rillig A, Hirokami J, Moser F, Bordignon S, Rottner L, Shota T, My I, Urbani A, Lemoine M, Kheir J, Schenker N, Urbanek L, Govorov K, Schaack D, Obergassel J, Riess J, Ismaili D, Kirchhof P, Ouyang F, Schmidt B, Reissmann B, Chun KJ, Metzner A. General anaesthesia and deep sedation for monopolar pulsed field ablation using a lattice-tip catheter combined with a novel three-dimensional mapping system. Europace. 2024 Nov 1;26(11):euae270. doi: 10.1093/europace/euae270.

  PMID: 39576055 RESULT

• Sochorova V, Kunstatova V, Osmancik P, Duska F, Herman D, Waldauf P, Poviser L, Karch J, Znojilova L, Filipcova V, Hozmanova J, Vesela J, Hozman M. COOPERATIVE-PFA: A Three-Arm Randomized Controlled Trial. Circulation. 2025 Jul 22;152(3):150-159. doi: 10.1161/CIRCULATIONAHA.125.074427. Epub 2025 Apr 27.

  PMID: 40287932 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2026
• First Posted: June 2, 2026
• Study Start: May 25, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: June 2, 2026

Record last verified: 2026-05

Locations

CN (1)