Efficacy and safety of pulsed field ablation in refractory mitral isthmus-dependent atrial flutter: pulsed field ablation vs. radiofrequency ablation: a preliminary randomized controlled study
This study aims to compare the effectiveness of pulse field ablation (PFA) versus radiofrequency ablation (RFCA) in improving mitral valve commissural block rate and atrial tachycardia recurrence rate in patients with refractory mitral valve commissural-dependent atrial flutter. Study Design: Randomized Groups: Patients will be randomly assigned to two groups: Pulse Field Ablation (PFA) Group Radiofrequency Ablation (RFCA) Group
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
The pulse field ablation group will undergo pulse field ablation of the mitral valve commissure.
In the radiofrequency ablation group, patients will undergo radiofrequency ablation targeted at the mitral valve commissure.
Shanghai Chest Hospital
Shanghai, China
Achieve persistent mitral isthmus block
After mitral isthmus block, wait for 20 minutes, and obtain persistent MI block after the waiting period.
Time frame: Immediate post-operative mitral isthmus block rate.
Episodes of atrial fibrillation, atrial flutter, or atrial tachycardia lasting ≥30 seconds occurred.
During the 3-month post-operative follow-up, episodes of atrial fibrillation, atrial flutter, or atrial tachycardia lasting ≥30 seconds occurred.
Time frame: During the 3-month post-operative follow-up.
The safety endpoint
The safety endpoint is a composite of major safety events, including pericardial tamponade or perforation, peripheral or organ thromboembolism, stroke or transient ischemic attack, persistent (lasting longer than hospitalization) phrenic nerve paralysis, atrioventricular block, pericarditis, vascular access complications requiring intervention, myocardial infarction, angina, myocardial infarction, coronary artery spasm, atrial-esophageal fistula, and death.
Time frame: During the 3-month post-operative follow-up.
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