Atrial fibrillation
Conditions
Interventions
None listed
Sponsors
Division of Cardiology, Department of Medicine, Nihon University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients undergoing initial catheter ablation for paroxysmal atrial fibrillation between the date of approval and 30 June 2024 at the Division of Cardiology, Department of Medicine, Nihon University School of Medicine, and collaborating institutions. Patients who have been fully informed about their participation in the study and who have given their free and voluntary written consent with full understanding.
Exclusion criteria
Exclusion criteria: 1) Patients with persistent atrial fibrillation. 2) Patients with a history of ablation 3) Patients who have difficulty in taking oral medication 4) Patients on dialysis 5) Patients with severe valvular heart disease 6) Patients who have difficulty in obtaining consent in person 7) Patients who have refused to participate in this study. 8) Any other Patients who are judged by the principal investigator to be unsuitable as a research subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| success rate of first-pass pulmonary vein isolation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) dormant conduction rate and sites 2) chronic recurrence rate 1 year after catheter ablation. 3) the success rate of first-pass pulmonary vein isolation and the reduction in operative duration by optimization of 90W/50W combination 4) incidence of ablation-related adverse events (cardiac tamponade, ischemic heart disease, stroke, gastro-esophageal disorders [gastric peristalsis, esophageal perforation], vascular injury, major bleeding events meeting ISTH criteria other than cardiac tamponade or clinically significant bleeding) during the peri-ablation period [up to 1 month post-operatively] 5) frequency of 40 dgree rise in esophageal temperature and the maximum esophageal temperature during ablation 6) the relationship between the sites of pulmonary vein reconnection and patient background, ablation conditions, energization index, energization interval, intracardiac potentials and wall thickness on CT image 7) changes in symptoms and QoL from enrolment to 1 year 8) MACE (total mortality, non-fatal myocardial infarction, non-fatal stroke) 9) total mortality 10) cardiovascular death 11) non-fatal myocardial infarction 12) non-fatal cerebral infarction 13) heart failure 14) pacemaker implantation 15) major bleeding event meeting ISTH criteria (fatal hemorrhage, intracranial hemorrhage, intrathecal hemorrhage, intrathecal hemorrhage, intraocular hemorrhage, intrapericardial hemorrhage, intra-articular hemorrhage intramuscular hemorrhage with compartment syndrome, retroperitoneal hemorrhage, gastrointestinal hemorrhage hemoglobin level falls by greater than or equal to 20 g/L (1.24 mmol/L) bleeding, bleeding requiring transfusion of more than 2 units of whole blood or red blood cells) 16) clinically significant bleeding | — |
Countries
Japan
Contacts
Public ContactRyuta Watanabe
Nihon University School of Medicine Division of Cardiology, Department of Medicine
Outcome results
None listed