A Study of Varipulse Catheter in Participants With Paroxysmal Atrial Fibrillation Under Optimized Sedation

Sex: All

Ages: 18 Years – 80 Years

Healthy volunteers: No

Enrollment: 300

Sponsor: Johnson & Johnson Medical (Shanghai) Ltd.

Summary

The main purpose of the study is to assess how well the standard ablation procedure (Varipulse Catheter) works over long term when used with different types of anesthesia in participants with symptomatic paroxysmal atrial fibrillation (PAF, irregular heartbeat that comes and goes on its own, causing noticeable symptoms like a racing heart, or shortness of breath).

Eligibility Criteria

Inclusion criteria: * Diagnosed with I and/or III antiarrhythmic drugs (AAD)-refractory symptomatic paroxysmal atrial fibrillation (PAF) or intolerable to class I and/or III AAD based on medical records * Age 18-80 years * Able and willing to comply with all pre-procedure, post-procedure, and follow-up testing and visit requirements * Signed patient informed consent form (ICF) Exclusion criteria: * Atrial fibrillation (AF) secondary to electrolyte imbalance, hyperthyroidism, or reversible or non-cardiac cause * Previous left atrium (LA) ablation or surgery * Left atrium diameter (LAD) greater than (\>) 50 millimeters (mm) by transthoracic echocardiography (TTE) * Left ventricular ejection fraction (LVEF) less than (\

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07511166). StuddyBuddy aggregates publicly available trial information.