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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorJohnson & Johnson Medical (Shanghai) Ltd.

About this trial

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

Qualifiers

Diagnosed with drug-refractory symptomatic paroxysmal atrial fibrillation (PAF) or intolerable to class I and/or III antiarrhythmic drugs (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)

Disqualifiers

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 (<) 40 percent (%)

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

300 Participants
are grouped into 2 trial groups

Locations

This trial has no locations