STELLAR: Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (STELLAR)

The primary objective of this study is to demonstrate safety and 12-month effectiveness of the Multi-Electrode RF Balloon catheter for the treatment of drug refractory symptomatic paroxysmal atrial fibrillation (PAF). Specifically:

• To demonstrate the safety based on the incidence of early-onset (within 7 days of ablation procedure) primary adverse events.
• To demonstrate the 12-month effectiveness based on the proportion of subjects with freedom from documented asymptomatic and symptomatic AF/AT/AFL (of unknown origin) episodes based on electrocardiographic data through the effectiveness evaluation period (day 91-365 post index procedure).

Inova Fairfax Hospital
3300 Gallows Road
Falls Church, VA 22042

Haroon Rashid, MD

1. Diagnosed with Symptomatic PAF
    a. At least two (2) symptomatic AF episodes within last six (6) months from enrollment
    b. At least one (1) electrocardiographically documented AF episode within twelve (12) months prior to enrollment

2. Failed at least one (1) Class I or Class III AAD as evidenced by recurrent symptomatic AF, contraindication to the AAD, or intolerable side effects to the AAD

3. Age 18 -75 years

1. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
2. Previous surgical or catheter ablation for AF
3. Patients known to require ablation outside the PV ostia and CTI region
4. Previously diagnosed with persistent or long-standing persistent AF and/or Continuous AF
5. Any percutaneous coronary intervention within the past 2 months
6. Valve repair or replacement or presence of a prosthetic valve
7. Any carotid stenting or endarterectomy within the past 6 months
8. Coronary artery bypass grafting, cardiac surgery
9. Documented left atrium (LA) thrombus
10. LA antero posterior diameter > 50 mm
11. Left Ventricular Ejection Fraction (LVEF) < 40%
12. History of blood clotting or bleeding abnormalities
13. Myocardial infarction within the past 2 months