Persistent Atrial Fibrillation Persistent Atrial Fibrillation,Posterior Wall Isolation,Pulsed Field Ablation
Conditions
Interventions
Subjects were randomized to receive either pulmonary vein isolation (PVI) alone or PVI combined with posterior wall isolation (PWI).
D016606
Sponsors
Okumura Yasuo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients aged 18 years or older at the time of obtaining informed consent. 2.Patients diagnosed with persistent atrial fibrillation (AF),defined as AF lasting for 7 days or more or requiring cardioversion,based on a 12-lead electrocardiogram or Holter monitoring. 3.Patients with symptomatic persistent AF who are refractory to, intolerant of, or contraindicated for Class I or Class III antiarrhythmic drugs. 4.Patients with a duration of AF of 3 years or less. 5Patients who have the willingness and ability to participate in all follow-up assessments and examinations conducted at an approved study site. 6.Patients who have provided written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1.Atrial,valvular, and myocardial conditions a. Patients with a history of left atrial ablation (including PVI). b. Patients with a left atrial diameter (LAD) > 55 mm on echocardiography performed within 4 weeks prior to consent. c. Patients with a left ventricular ejection fraction (LVEF) 160 mmHg or DBP > 95 mmHg confirmed at baseline on two occasions). c. Patients with bleeding disorders or inability to achieve adequate anticoagulation. d. Patients with active hematologic disease (e.g.,bleeding diathesis,thrombocytopenia, leukemia,malignant lymphoma,myelodysplastic syndrome). e. Patients with embolic protection filters in the vena cava or femoral thrombus requiring femoral access. f. Patients with a history of organ or hematopoietic stem cell transplantation, or currently undergoing transplant evaluation. g. Patients with active or progressive malignancy (remission cases are eligible). h. Patients with obesity (BMI > 40.0). i. Patients with uncontrolled diabetes or HgbA1c > 8.0% within 90 days prior to consent. j. Patients with untreated severe obstructive sleep apnea (apnea-hypopnea index > 30). k. Patients with contraindications to anticoagula
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| compare the efficacy and safety between pulmonary vein isolation (PVI) alone and PVI combined with posterior wall isolation (PWI) in patients with persistent atrial fibrillation who underwent pulsed field ablation (PFA) using the FARAPULSE system. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Incidence of individual events (e.g., success (ablation) procedure in acute phase,reablation,electrical cardioversion,dose escalation of antiarrhythmic drug therapy,etc.) 2.Time to atrial fibrillation (AF) recurrence (time-to-event analysis) 3.AF burden (percentage of time in atrial fibrillation) 4.Changes in quality of life scores (assessed by AFEQT and EQ-5D-5L) | — |
Contacts
Public ContactYasuhiko Yoshida
Nouvelle Place Inc.
Outcome results
None listed