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

Primary Objective

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 Atrial Fibrillation, Atrial Tachycardia, or Atrial Flutter episodes

Study category: Heart and Blood Conditions

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Description

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

Details
Age

Adult

Type of Study

Treatment

Locations

Harmony Campus
Medical Center of the Rockies

Principal Investigator
Ethan Ellis,  MD

Ethan Ellis, MD

Study ID

Protocol Number: 19-6101

More information available at ClinicalTrials.gov: NCT03683030

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