The Impact of Atrial Pressure Change Before and After One-stop Procedure Combining Catheter Ablation and Left Atrial Appendage Closure on the Prognosis of Patients With Atrial Fibrillation
Collecte de données
Données recueillies dès le début de l'étude - ProspectiveArythmies cardiaques+4
+ Fibrillation Auriculaire
+ Maladies Cardiovasculaires
Cohorte
Suivi d'un groupe de personnes dans le temps pour mieux comprendre les causes et l'évolution d'une maladie.Résumé
Date de début de l'étude : 10 novembre 2021
Date à laquelle le premier participant a commencé l'étude.1. Study aim. This study was designed to measure the left and right atrial pressure change before and after catheter ablation (CA) and left atrial appendage closure (LAAC) combining procedure, and investigate the influence of the pressure change on clinical outcomes. 2. Subject selection. This study is designed to recruit patients diagnosed with atrial fibrillation and planned to undergo combined procedure. Primary inclusion criteria are: i. Atrial fibrillation recorded by 12-lead ECG or Holter that last for longer than 30 seconds within the preceding 6 months; ii. Eligible for left atrial appendage closure, that meet at least one of the followings: 1. At high risk of stroke (CHA2DS2-VASc score≥3 in female, ≥2 in male) and/or bleeding (HAS-BLED score≥3); 2. Contraindicated to oral anticoagulation (OAC); 3. Refused OAC treatment albeit comprehensively informed of the necessity and benefits of OAC treatment. 3. Procedure detail. All the patients recruited is planned to undergo combined procedure. CA is performed before LAAC. For CA, the energy source is optional (either radiofrequency or cryoenergy). And ablation should be performed for pulmonary vein isolation only. For LAAC, the occluder type is optional (either plug or pacifier occluder), and intracardiac echocardiography or transesophageal echocardiography (TEE) is optional. For atrial pressure measurement, right atrial pressure should be measured before transseptal puncture and after combined procedure is accomplished. Left atrial pressure should be measured at 3 timepoints: after transseptal puncture, after pulmonary vein isolation and after LAAC. Atrial pressure is measured via Swartz transseptal puncture sheath. And at each timepoint, atrial pressure should be recorded at 1min, 3min, and 5min after the placement of the sheath. 4. Follow-up. study endpoint includes a primary composite endpoint of rehospitalization due to heart failure and death due to cardiovascular disease, and secondary endpoints including: 1. all-cause mortality 2. major cardiovascular adverse event 3. rehospitalization due to cardiovascular diseases 4. recurrence of atrial arrhythmia 5. stoke/transient ischemic attack 6. echocardiographic measurement 7. quality of life evaluation 8. cardiac function evaluation 9. evaluation of left atrial appendage closure. Patients are required to have outpatient follow-up at 3rd month, 12th month, and every year since then. The anti-thromboembolic regimen should follow: 3-month OAC treatment and 3-month double anti-platelet therapy and lifelong single anti-platelet therapy. For LAAC follow-up, either TEE or CTA is scheduled to perform in the 3rd month after procedure.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.100 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Cohorte
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: * Atrial fibrillation recorded by 12-lead ECG or Holter that last for longer than 30 seconds within the preceding 6 months; * Eligible for left atrial appendage closure, that meet at least one of the followings: 1. At high risk of stroke (CHA2DS2-VASc score≥3 in female, ≥2 in male) and/or bleeding (HAS-BLED score≥3); 2. Contraindicated to oral anticoagulation (OAC); 3. Refused OAC treatment albeit comprehensively informed of the necessity and benefits of OAC treatment. * Capable of understanding and signing the informed consent form. * Aged over 18 years. Exclusion Criteria: * Reversible causes of atrial fibrillation, including thyroid disorders, recent major surgery, trauma, acute alcoholic intoxication; * Concomitant arrhythmia including atrial flutter, ventricular tachycardia; * A previous history of atrial fibrillation surgery (MAZE surgery) or catheter ablation; * A previous history of cardiac surgery including any valvular replacement, septal repair; * A recent history of major cardiovascular disease within 3 months, including acute myocardial infarction, ventricular fibrillation; * A history of congenital heart disease; * A previous history of atrioventricular node ablation; * A history of lobectomy due to any medical condition; * Complicated by other diseases with life expectation \<1 year; * Women with childbearing potential; * Participated in other interventional clinical trials that might affect prognosis; * Unable to understand or give informed consent form.
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Objectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
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Department of Cardiology, Shanghai Tenth People's Hospital
Shanghai, ChinaOuvrir Department of Cardiology, Shanghai Tenth People's Hospital dans Google Maps