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

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Conditions studied: Atrial Fibrillation

In brief

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).

Key facts

Study ID

NCT07511166

Run by

Johnson & Johnson Medical (Shanghai) Ltd.

People needed

300

Starts

2026-09-07

Expected to finish

2028-07-28

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 (%)
• Known significant pulmonary vein (PV) anomaly that in the opinion of the investigator would preclude enrollment in this study
• Current enrollment in an investigational study evaluating another device or drug
• Women who are pregnant (as evidenced by pregnancy test or oral confirmation if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the course of the clinical investigation
• Life expectancy less than 12 months
• Presenting contra-indications for the devices used in the study, as indicated in the respective instructions for use (IFU)
• Presenting contra-indications for catheter ablation at physicians' discretion, for example LA/Left atrial appendage (LAA) thrombus, systematic infection, situations preventing catheter access
• Other conditions that, at discretion of the investigators, would preclude enrollment in this study

Full record on ClinicalTrials.gov

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