A Study on the Therapeutic Value of Additional Left Atrial Posterior Wall Isolation Guided by Voltage Mapping in Persistent Atrial Fibrillation.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHangzhou Dinova EP Technology Co., Ltd

About this trial

This prospective, multicenter, randomized controlled study was designed to investigate the feasibility, efficacy and safety of pulsed field ablation (PFA) strategies for persistent atrial fibrillation. For patients with persistent atrial fibrillation and normal left atrial substrate, pulmonary vein isolation combined with superior vena cava isolation will be performed. For those with abnormal left atrial substrate, two strategies will be adopted: pulmonary vein isolation plus superior vena cava isolation, and pulmonary vein isolation combined with superior vena cava isolation and left atrial posterior wall isolation. Long-term follow-up will be conducted to observe the long-term clinical outcomes.

Eligibility criteria

Qualifiers

Older than 18 years.

Diagnosed as persistent atrial fibrillation (AF); Definition: At least one episode of persistent AF was recorded on dynamic electrocardiogram (ECG) data within 12 months prior to enrollment, or other clinical evidence supporting persistent AF episodes lasting more than 7 days.

Subjects are able to understand the purpose of the study, voluntarily participate in the study and sign the informed consent, and are willing to complete the follow-up according to the requirements of the program.

Disqualifiers

Atrial fibrillation is secondary to thyroid disease or other reversible factors.

Evidence of left atrial or left atrial appendage thrombus on imaging examination.

Rheumatic heart disease or the presence of moderate to severe mitral stenosis or regurgitation.

Left ventricular ejection fraction <40% or New York Heart Association (NYHA) class III/IV.

Trial design

Treatments tested in this trial

  • superior vena cava isolation
  • Abnormal left atrial substrate

Treatment groups

350 Participants
are divided into 2 treatment groups