Deep Sedation vs. General Anesthesia for Pulsed Field Ablation in Atrial Fibrillation (SAFE-PFA)
31. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
80
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Jiangxi
-
Nanchang, Jiangxi, Kina, 330006
- The Second Affiliated Hospital of Nanchang University
-
Ta kontakt med:
- Qi Chen, MD, PhD
- Telefonnummer: +86-13330087688
- E-post: efycq@189.cn
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Deep Sedation Group
Patients undergoing atrial fibrillation pulsed field ablation under a novel deep sedation protocol
|
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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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.
|
From Operating Room entry to Operating Room exit
|
|
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 |
Tiltaksbeskrivelse |
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
|
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
|
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
|
|
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
|
|
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
|
|
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.
|
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
25. mai 2026
Primær fullføring (Antatt)
30. april 2027
Studiet fullført (Antatt)
30. april 2027
Datoer for studieregistrering
Først innsendt
16. mai 2026
Først innsendt som oppfylte QC-kriteriene
31. mai 2026
Først lagt ut (Faktiske)
2. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IIT-2026-026
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
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