Varipulse Catheter in Paroxysmal Atrial Fibrillation with Different Sedation Options

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate long-term outcomes of the Varipulse Catheter ablation procedure in adults with symptomatic paroxysmal atrial fibrillation who have not had adequate relief with antiarrhythmic drugs or cannot tolerate them, across varied anesthesia types. Participants will be adults ages 18 to 80 and must meet pre- and post-procedure testing and follow-up requirements with informed consent. The trial excludes AF caused by reversible conditions, prior left atrial surgery or ablation, larger left atrial size, reduced ejection fraction, certain PV anomalies, concurrent investigational therapies, and pregnancy. Lead sponsor is Johnson & Johnson Medical (Shanghai) with the study site at Zhongshan Hospital Fudan University in Shanghai, China.

Why it matters

Who can join: the full rules

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 (\<) 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

Where it's running

• Zhongshan Hospital Fudan University
  Shanghai, China Recruiting

Study contacts

• Study coordinator: YanTing Zhang
• Email: yzhan365@ITS.JNJ.com
• Phone: 13162835013

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.