atrial fibrillation atrrial fibrillation, pulsed-field ablation, strain
Conditions
Interventions
Pulmonary vein isolation group: Pulmonary vein isolation is performed using pulsed-field ablation for persistent atrial fibrillation.
Pulmonary vein isolation plus left atrial posterior wall isolation
catheter ablation
Sponsors
Miyamoto Koji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 20 to 85 years or younger at the time of informed consent 2. Patients undergoing pulsed-field ablation for persistent atrial fibrillation 3. Patients who can undergo echocardiography during sinus rhythm at the time of informed consent 4. Patients for whom written consent can be obtained
Exclusion criteria
Exclusion criteria: 1. Patients with active systemic infection 2. Patients with mechanical prosthetic heart valve 3. Patients with conditions where insertion into or manipulation in the cardiac chambers is unsafe as these conditions (e.g., presence of intracardiac thrombus or myxoma, etc.) 4. Patients with a bleeding disorder, or who are unable to receive heparin or an acceptable alternative adequate anticoagulation 5. Patients who have vena cava embolic protection filter devices and/or known femoral thrombus who require catheter insertion from the femoral approach 6. Patients with a contraindication to an invasive electrophysiology procedure where insertion or manipulation of a catheter in the cardiac chambers is deemed unsafe, such as but not limited to, a recent (within 3 months) previous cardiac surgery (e.g., ventriculostomy or atriotomy, Coronary Artery Bypass Graft, percutaneous coronary intervention, unstable angina) and/or in patients with congenital heart disease where the underlying abnormality increases the risk of the ablation (e.g. severe rotational anomalies of the heart or great vessels) 7. Patients with an intra-atrial baffle or foramen ovale patches 8. Patients with a history of cardiac surgery involving left atrial incision, those with a pacemaker implanted, or those with a history of ablation therapy for atrial fibrillation 9. Pregnant or possibly pregnant patients 10. Patients who are already participating in an intervention study of a drug or medical device or are scheduled to participate during the study period 11. Patients for whom participation in the study is judged inappropriate by the Principal Investigator or subinvestigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in left atrial strain (LA reservoir strain) during sinus rhythm in echocardiography at 3 months after ablation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Following values, amount of changes (change from baseline) 1. Left atrial strain (LA conduit strain, LA booster strain) on echocardiography 3 months after ablation 2. Left atrial posterior wall and anterior septal wall strain (LA reservoir, conduit, booster strain) on echocardiography 3 months after ablation 3. Echocardiographic measurements at 3 months post-ablation: E/e'/LA reservoir strain, left atrial diameter and volume (coefficient), left atrial ejection fraction, left ventricular end-diastolic diameter, E/e', left ventricular ejection fraction, left ventricular inflow waveform (E wave, A wave, E wave deceleration time), tissue Doppler waveform (mitral annular velocity e', a'), Presence and severity of tricuspid regurgitation (none/trivial, mild, moderate, severe), pressure gradient, presence and severity of mitral regurgitation (none/trivial, mild, moderate, severe) 4. Non-recurrence rate, frequency (AF burden), and time to recurrence of tachyarrhythmic atrial arrhythmias (atrial fibrillation, atrial flutter, atrial tachycardia) one year after ablation, excluding recurrences during the blanking period (within 8 weeks post-ablation). If re-ablation is performed during the blanking period, it is considered a recurrence. 5. Hb, BNP or NT-proBNP levels, Cr, CCr, eGFR at 3 months and 1 year post-ablation; incidence of cardiovascular events 1 year post-ablation (see definition in 9.6); all-cause mortality rate; symptom questionnaire (AFEQT) (see separate AFEQT document) 6. CK, CK-MB, Troponin I, Cr, CCr, eGFR, Hb, Haptoglobin, LDH, indirect bilirubin on the day after ablation 7. Pulmonary vein isolation success rate, left atrial posterior wall isolation success rate, total procedure time, left atrial procedure time, fluoroscopy time, frequency/type/success rate of additional treatments if performed, whether ablation was discontinued, reason for discontinuation 8. Ablation-related complications 9. Adverse events # 8 and 9 are safety related outcomes | — |
Contacts
Public ContactKoji Miyamoto
National Cerebral and Cardiovascular Center
Outcome results
None listed