Deep Sedation vs. General Anesthesia for Pulsed Field Ablation in Atrial Fibrillation (SAFE-PFA)
31 mai 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
80
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Jiangxi
-
Nanchang, Jiangxi, Chine, 330006
- The Second Affiliated Hospital of Nanchang University
-
Contact:
- Qi Chen, MD, PhD
- Numéro de téléphone: +86-13330087688
- E-mail: efycq@189.cn
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
|
|
Comparateur placebo: General Anesthesia Group
Patients undergoing atrial fibrillation pulsed field ablation under general anesthesia
|
Atrial fibrillation pulse filed ablation using a standard endotracheal intubation general anaesthesia protocol
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Operating Room Occupancy Time
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Post-operative Recovery Time
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
25 mai 2026
Achèvement primaire (Estimé)
30 avril 2027
Achèvement de l'étude (Estimé)
30 avril 2027
Dates d'inscription aux études
Première soumission
16 mai 2026
Première soumission répondant aux critères de contrôle qualité
31 mai 2026
Première publication (Réel)
2 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
2 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
31 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IIT-2026-026
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .