3-Dimensional Mapping System: The PULSTAR Study

Korábbi kezelés

• Patients who have undergone left atrial surgery
• Previous atrial septal repair or atrial mucinous tumor
• Active implants (e.g. pacemakers, ICDs, etc.) in the body
• Patients who have participated or are participating in other clinical trials within 3 months prior to enrollment

Más betegség

• Left atrial thrombosis
• NYHA class III-IV cardiac function [Appendix 1]
• Clear cerebrovascular disease within the last 6 months (including cerebral hemorrhage, stroke, transient ischemic attack)
• Cardiovascular events within the last 3 months (including acute myocardial infarction, coronary intervention or heart bypass surgery, prosthetic valve replacement or repair, atrial or ventriculotomy)
• Those with acute or severe systemic infections
• Patients with severe liver or kidney disease, malignant tumors or end-stage disease that, in the opinion of the investigator, may interfere with the treatment, evaluation and compliance of this trial
• Patients with significant bleeding tendency, hypercoagulable state and severe hematologic disorders
• Patients who have other conditions that the investigator considers inappropriate for participation in this trial.

Laborértékek

• Left ventricular ejection fraction (LVEF) ≤ 40%

Életkor

• Patients of childbearing age who are unable to use effective contraception during the 12-month period after enrollment

Egyéb

• Anterior and posterior left atrial diameter ≥ 50 mm

• ≥18 and ≤75 years of age.
• Paroxysmal atrial fibrillation diagnosed by electrocardiogram or Holter ECG (including single-lead ECG recorder, lasting≥30s) within 1 year prior to enrollment.
• Clinical diagnosis of paroxysmal atrial fibrillation.
• Symptomatic patients who are ineffective or intolerant to at least one antiarrhythmic medication; or patients who are willing to undergo ablation despite not being on medication.
• Fully understand the treatment protocol and voluntarily sign the informed consent form and be willing to undergo the tests, procedures and follow-ups required by the protocol.