Deep Sedation vs. General Anesthesia for Pulsed Field Ablation in Atrial Fibrillation (SAFE-PFA)
31. maj 2026 opdateret af: 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
- 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
- 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.
- Study Design: Interventional clinical study
- Study Subjects: Patients with atrial fibrillation scheduled for catheter ablation at the Second Affiliated Hospital of Nanchang University between January 2026 and January 2027.
- 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.
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
- 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.
- 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
80
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Jiangxi
-
Nanchang, Jiangxi, Kina, 330006
- The Second Affiliated Hospital of Nanchang University
-
Kontakt:
- Qi Chen, MD, PhD
- Telefonnummer: +86-13330087688
- E-mail: efycq@189.cn
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Deep Sedation Group
Patients undergoing atrial fibrillation pulsed field ablation under a novel deep sedation protocol
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A deep sedation protocol using dexmedetomidine, remifentanil and remazolam for atrial fibrillation pulse field ablation
|
|
Placebo komparator: General Anesthesia Group
Patients undergoing atrial fibrillation pulsed field ablation under general anesthesia
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Atrial fibrillation pulse filed ablation using a standard endotracheal intubation general anaesthesia protocol
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Operating Room Occupancy Time
Tidsramme: 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.
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From Operating Room entry to Operating Room exit
|
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Net Procedure Duration
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Post-operative Recovery Time
Tidsramme: 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
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From procedure completion to transfer to the general ward, assessed up to 24 hours post-procedure
|
|
Acute Pulmonary Vein Isolation (PVI) Success Rate
Tidsramme: At the end of the ablation procedure
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The percentage of pulmonary veins successfully isolated using pulsed field ablation (PFA) as confirmed by the electrophysiological mapping system.
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At the end of the ablation procedure
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Incidence of Hypoxemia
Tidsramme: Periprocedural period
|
Percentage of patients experiencing oxygen saturation (SpO2) < 90% requiring intervention (e.g., increasing oxygen flow or airway maneuvers).
|
Periprocedural period
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|
Incidence of Hypotension
Tidsramme: 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
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Patient Pain Intensity (NRS Score)
Tidsramme: 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).
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2 hours and 24 hours post-operation
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Total Fluoroscopy Dose (DAP)
Tidsramme: At the end of the procedure
|
The cumulative radiation exposure to the patient, measured as Dose Area Product (DAP) in cGy·cm².
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At the end of the procedure
|
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Incidence of Perioperative Complications
Tidsramme: up to 30 days post-procedure
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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.
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up to 30 days post-procedure
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
25. maj 2026
Primær færdiggørelse (Anslået)
30. april 2027
Studieafslutning (Anslået)
30. april 2027
Datoer for studieregistrering
Først indsendt
16. maj 2026
Først indsendt, der opfyldte QC-kriterier
31. maj 2026
Først opslået (Faktiske)
2. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IIT-2026-026
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