Pulsed Field Ablation for Atrial Fibrillation Under General Anesthesia Versus Remimazolam-based Deep Sedation
Atrial Fibrillation (AF)
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 200 Estimado
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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
Real-world evidence indicates that deep sedation is the predominant anesthesia strategy for pulsed field ablation (PFA) in most European centers, whereas general anesthesia remains the standard of care in China. Given disparities in anesthesiologist availability and fundamental differences in healthcare system infrastructure and workflow organization, establishing an electrophysiologist-led deep sedation pathway has the potential to streamline PFA procedural logistics, enhance perioperative patient comfort, and facilitate the standardized, scalable, and sustainable implementation of this novel technology. This study aims to determine whether pulmonary vein isolation (PVI) performed with PFA under a remimazolam-based deep sedation protocol is non-inferior to PVI under general anesthesia in terms of both safety and efficacy among patients with atrial fibrillation (AF).
Leer la descripción completa
Eligible patients with atrial fibrillation (AF) will be randomly assigned in a 1:1 ratio, stratified by AF type (paroxysmal vs. persistent), to either the general anesthesia group (GA group) or the deep sedation group (DS group). All participants will undergo bilateral pulmonary vein isolation (PVI) using a pulsed field ablation (PFA) catheter; additional ablation beyond PVI will be performed at the operator's discretion based on procedural assessment.
Patients in the GA group will receive general anesthesia per institutional standard of care. Patients in the DS group will receive remimazolam-fentanyl-based deep sedation according to a standardized protocol.
Intraoperative monitoring will include continuous 12-lead electrocardiography (ECG), pulse oximetry (SpO₂), and noninvasive arterial blood pressure measurement-at minimum.
All participants will undergo a scheduled follow-up visit at 2 months post-procedure.
¿Quién podría participar?
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Inclusion Criteria:
1. At the time of enrollment, the legal age is ≥ 18 years old;
2. Patients with non-valvular atrial fibrillation who have indications for atrial fibrillation ablation;
3. Intend to receive atrial fibrillation ablation for the first time;
4. Able to provide informed consent, willing to participate in follow-up visits and provide relevant information.
Exclusion Criteria:
1. Secondary atrial fibrillation due to electrolyte imbalance or other reversible or non-cardiac causes;
2. Contraindications to PFA procedure, anticoagulant drugs or anesthetic drugs;
3. Acute myocardial infarction or stroke within 3 months;
4. Heart Failure subjects with NYHA III/IV or LVEF \< 40%;
5. BMI ≥ 35 kg/m²;
6. Sleep apnea syndrome, or anticipated airway difficulty;
7. COPD GOLD III/IV grade, severe asthma and other respiratory diseases;
8. Clinical conditions assessed by the investigator as unsuitable for deep sedation, such as high reflux and high aspiration risk;
9. Clinical conditions assessed by the investigator as intolerant to the procedure, such as severe liver and kidney dysfunction.
Tratamiento, grupos y participación
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- Asignación
- Asignación al azar
- Enmascaramiento
- Sin enmascaramiento
General Anesthesia
Subjects in this arm will accept PFA procedure under general anesthesia .
Procedure: General Aneasthesia
Deep Sedation
Subjects in this arm will accept PFA procedure under deep sedation using the protocol of remimazolam and fentanyl.
Procedure: Deep sedation
Deep sedation PROCEDURE
For induction period, remimazolam will be administered as a slow intravenous bolus followed by fentanyl via intravenous injection. For maintenance period, continuous intravenous infusions of remimazolam and fentanyl will be applied. Dosages will be titrated dynamically based on real-time monitoring of the blood pressure to maintain hemodynamic stability. Prior to the first application, a bolus of fentanyl and remimazolam will be administered.
General Aneasthesia PROCEDURE
Subjects will accept PFA procedure under general anesthesia under standard of care.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Incidence of the composite failure events, including clinical hypoxemia, clinical hypotension, and anesthesia failure.
Plazo: During the index procedure
1. Anesthesia failure is defined as intolerance to the randomly assigned anesthetic regimen during the procedure, requiring a switch to an alternative anesthetic approach to ensure procedural success.
2. Clinical hypoxemia is defined as oxygen saturation \< 85% lasting for 1 minute or the need for clinical intervention (increased fraction of inspired oxygen, airway management, or drug administration) or resulting in procedure discontinuation.
3. Clinical hypotension is defined as systolic blood pressure \< 85 mmHg lasting for at least 1 minute or the need for pharmacological intervention or resulting in procedure discontinuation
Medidas secundarias
The incidences of anesthesia-related adverse events (e.g., vomiting, dry cough, cognitive dysfunction, airway injury).
Plazo: During the index procedure
No informado en este registro.
Early recurrence rate at 2 months
Plazo: 60 days
Defined as the proportion of subjects with documented atrial arrhythmias lasting ≥30s within 60 days
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (0)
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No hay centros indicados. Usa el contacto oficial del estudio.
Equipo y fechas
- Patrocinador principal
- China National Center for Cardiovascular Diseases
- Inicio del estudio
- 30 nov 2026 Estimado
- Finalización primaria
- 30 nov 2027 Estimado
- Finalización del estudio
- 28 feb 2028 Estimado
- Primera publicación
- 10 nov 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
A Randomized Controlled Study on the Efficacy of Pulsed Field Ablation for Atrial Fibrillation Under General Anesthesia Versus Remimazolam-based Deep Sedation
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026