Efficacy and Safety of Superior Vena Cava Isolation and Pulmonary Vein Isolation for Treatment of Atrial Fibrillation (SAVE-AF)
23 juillet 2026 mis à jour par: Qiang Hu
Efficacy and Safety of Superior Vena Cava Isolation in Addition to Pulmonary Vein Isolation by Pulsed Field Ablation for Treatment of Atrial Fibrillation
Atrial fibrillation (AF) is one of the most concerning diseases in the field of cardiac arrhythmias.
It is a type of rapid supraventricular arrhythmia characterized by rapid and disorganized contraction of the atria, which leads to ventricular rate disturbance, impaired cardiac function, and an increased risk of atrial mural thrombus formation.
AF severely reduces patients' quality of life and can cause complications such as heart failure, stroke, and sudden death.
Currently, the vast majority of AF episodes are triggered by pulmonary vein (PV) ectopic foci.
Therefore, catheter ablation is the preferred treatment strategy, with pulmonary vein isolation (PVI) being the cornerstone procedure.
However, a small proportion of patients may have non-PV triggers, particularly originating from the superior vena cava (SVC).
Conventional radiofrequency ablation (RFA) for SVC isolation carries unpredictable risks, including damage to the sinus node and the phrenic nerve.
Therefore, this study aims to investigate the impact of empirical SVC electrical isolation in addition to PVI on the success rate of AF ablation, using pulsed field ablation (PFA)-a non-thermal ablation modality with tissue selectivity and a favorable safety profile.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
200
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.
Coordonnées de l'étude
- Nom: Qiang Hu, Doctor
- Numéro de téléphone: +8602886590223
- E-mail: huqiang071@foxmail.com
Lieux d'étude
-
-
Sichuan
-
Chengdu, Sichuan, Chine, 610000
- Recrutement
- Qiang Hu
-
Contact:
- Qiang Hu, Doctor
- Numéro de téléphone: +8602886590223
- E-mail: huqiang071@foxmail.com
-
-
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 years;
- Patients with documented atrial fibrillation (AF), confirmed by at least one episode of AF recorded on a 12-lead surface electrocardiogram (ECG) or ambulatory ECG monitoring within the past 12 months;
- Subjects who agree to undergo treatment for AF using a pulsed field ablation (PFA) system that is currently commercially available in China;
- Patients who have shown an inadequate response to, or intolerance of, at least one class of antiarrhythmic drug therapy;
- Subjects or their legally authorized representatives who have been informed of the nature of this study, have agreed to all terms and conditions of the study, and have provided written informed consent, and who are willing to complete all required clinical follow-up visits in accordance with the study protocol.
Exclusion Criteria:
- Prior surgical or catheter ablation for any type of cardiac arrhythmia;
- AF secondary to electrolyte imbalance, valvular heart disease, thyroid disease, or other reversible causes;
- Known requirement for ablation outside the pulmonary vein ostia or beyond the cavotricuspid isthmus;
- Sinus node dysfunction or other indications for permanent pacemaker implantation;
- Myocardial infarction, or prior coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within the past 6 months;
- Left atrial anteroposterior diameter ≥ 50 mm;
- Evidence of left atrial or left atrial appendage thrombus confirmed by transesophageal echocardiography (TEE) or left atrial computed tomography (CT) within 24 hours prior to the procedure;
- Serum creatinine > 2 times the upper limit of normal, or currently on dialysis;
- History of prior cardiothoracic surgery;
- History of permanent pacemaker implantation;
- History of malignancy;
- Long-term use of a central venous catheter;
- Contraindications to anticoagulation therapy (including allergy to anticoagulants, thrombocytopenia, severe bleeding tendency, or coagulation disorders);
- History of allergy to contrast;
- Women who are pregnant, lactating, or who are unwilling to use adequate contraception during the study period;
- Subjects or their legally authorized representatives who are unwilling to provide written informed consent;
- Subjects who, for any reason, are unable to comply with the study protocol or complete all required clinical follow-up visits;
- Subjects deemed by the investigator to be unsuitable for PFA treatment of AF.
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: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: superior vena cava isolation plus pulmonary vein isolation
|
Eligible patients with atrial fibrillation who are randomized to the experimental group will undergo superior vena cava (SVC) electrical isolation in addition to pulmonary vein isolation (PVI) during the pulsed field ablation procedure
|
|
Comparateur actif: pulmonary vein isolation
|
Eligible patients with atrial fibrillation who are randomized to the control group will undergo pulmonary vein isolation (PVI) during the pulsed field ablation procedure
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
the success rate of atrial fibrillation ablation
Délai: at 3 month
|
it is assessed by 7-day Holter monitoring
|
at 3 month
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
the success rate of atrial fibrillation ablation
Délai: at 6 month and 12 month
|
it is assessed by 7-day Holter monitoring
|
at 6 month and 12 month
|
|
left ventricular end-systolic diameter
Délai: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
left ventricular end-diastolic diameter
Délai: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
left ventricular posterior wall thickness
Délai: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
interventricular septal thickness
Délai: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
left ventricular ejection fraction
Délai: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
E/A
Délai: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
E/e'
Délai: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
left atrial volume index
Délai: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
left atrial anteroposterior diameter
Délai: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
left atrial strain
Délai: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
New York Heart Association class
Délai: at 3 month, 6 month and 12 month
|
The NYHA is measured by Classification of NYHA heart function
|
at 3 month, 6 month and 12 month
|
|
Major adverse events
Délai: at 3 month, 6 month and 12 month
|
Major adverse events is a composite endpoint of death, stroke, and myocardial infarction.
|
at 3 month, 6 month and 12 month
|
|
6-min walk distance
Délai: at 3 month, 6 month and 12 month
|
During the test, patients were asked to walk for 6 minutes on a long corridor with a length of 37.5 meters between the 2 marks
|
at 3 month, 6 month and 12 month
|
|
red blood cell count
Délai: at 3 month, 6 month and 12 month
|
It is obtained from the routine blood test.
|
at 3 month, 6 month and 12 month
|
|
hemoglobin
Délai: at 3 month, 6 month and 12 month
|
It is obtained from the routine blood test.
|
at 3 month, 6 month and 12 month
|
|
white blood cell count
Délai: at 3 month, 6 month and 12 month
|
It is obtained from the routine blood test.
|
at 3 month, 6 month and 12 month
|
|
platelet count
Délai: at 3 month, 6 month and 12 month
|
It is obtained from the routine blood test.
|
at 3 month, 6 month and 12 month
|
|
alanine aminotransferase
Délai: at 3 month, 6 month and 12 month
|
It is obtained from the liver function test.
|
at 3 month, 6 month and 12 month
|
|
aspartate aminotransferase
Délai: at 3 month, 6 month and 12 month
|
It is obtained from the liver function test.
|
at 3 month, 6 month and 12 month
|
|
creatinine
Délai: at 3 month, 6 month and 12 month
|
It is obtained from the renal function test
|
at 3 month, 6 month and 12 month
|
|
urea
Délai: at 3 month, 6 month and 12 month
|
It is obtained from the renal function test
|
at 3 month, 6 month and 12 month
|
|
estimated glomerular filtration rate
Délai: at 3 month, 6 month and 12 month
|
It is obtained from the renal function test
|
at 3 month, 6 month and 12 month
|
|
activated partial thromboplastin time
Délai: at 3 month, 6 month and 12 month
|
It is obtained from the coagulation function test
|
at 3 month, 6 month and 12 month
|
|
prothrombin time
Délai: at 3 month, 6 month and 12 month
|
It is obtained from the coagulation function test
|
at 3 month, 6 month and 12 month
|
|
international normalized ratio
Délai: at 3 month, 6 month and 12 month
|
It is obtained from the coagulation function test
|
at 3 month, 6 month and 12 month
|
|
B-type natriuretic peptide
Délai: at 3 month, 6 month and 12 month
|
It is obtained from a blood sample.
|
at 3 month, 6 month and 12 month
|
|
Atrial Fibrillation Effect on Quality of Life Questionnaire
Délai: at 3 month, 6 month and 12 month
|
AFEQT questionnaire was used to assess the quality of life of patients with atrial fibrillation.
|
at 3 month, 6 month and 12 month
|
|
readmission
Délai: at 3 month, 6 month and 12 month
|
Rehospitalization was indicated for atrial fibrillation.
|
at 3 month, 6 month and 12 month
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
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 (Réel)
20 juillet 2026
Achèvement primaire (Estimé)
31 mars 2029
Achèvement de l'étude (Estimé)
31 mars 2029
Dates d'inscription aux études
Première soumission
21 juillet 2026
Première soumission répondant aux critères de contrôle qualité
21 juillet 2026
Première publication (Réel)
24 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
27 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
23 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- N2026-07
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
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 .