About this trial
The latest OCTARAY multi-electrode mapping catheter and TUREref technology were used to perform ultra-high precision mapping on the left atrial and left atrial auricle of persistent atrial fibrillation in the condition of sinus rhythm and atrial fibrillation respectively, and the density and accuracy of potential were significantly improved. According to the mapping results, the numerical calculation of the personalized low voltage region was carried out, and the personalized ablation route was designed according to the low voltage region.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 to 85 years;
Diagnosed with drug-refractory, symptomatic, persistent atrial fibrillation; Definition: At least one electrocardiogram (ECG) record of an atrial fibrillation episode within 12 months prior to enrollment.
Non-valvular atrial fibrillation;
Able to understand the purpose of the study, voluntarily participate in the study, the patient or their legal representative signs the informed consent form, and willing to complete follow-ups as required by the study protocol.-
Disqualifiers
Atrial fibrillation secondary to thyroid disease or other reversible factors;
Imaging studies indicating intracardiac thrombus;
Moderate to severe mitral stenosis or regurgitation;
Left ventricular ejection fraction <40%, or New York Heart Association (NYHA) functional class III or IV;
Trial design
Parallel
Treatments tested in this trial
non-pulmonary vein ablation group
Procedure/SurgeryIn the non-pulmonary vein ablation group, pulmonary vein isolation was not allowed, but the left atrial low-voltage area was treated first, and then the ablation route that terminated the reentry ring was treated.
only pulmonary vein ablation group
Procedure/SurgeryIn the group treated with only pulmonary vein ablation route, only potential isolation of pulmonary vein was performed, and bidirectional block was the end point.
Treatment groups
Trial outcomes
Primary outcomes
Immediate Atrial Fibrillation Termination Rate
The number of atrial fibrillation rhythms ablated to sinus rhythm or flutter/atrial tachycardia during the procedure.
Secondary outcomes
Ablation Success Rate at 12 Months Post-Operation.
No electrocardiogram (ECG) recordings of atrial fibrillation, flutter, or tachycardia lasting ≥30 seconds from the end of the blanking period to the end of the 12-month follow-up.
Other outcomes
The number and location of re-entrant circuits mapped during surgery
the location of ablation to sinus rhythm or flutter
the number of three-dimensional mapping points
Locations
Sponsors and contacts
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