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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
Description
Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation
Details
Age
Adult
Phase
III - Research Studies that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.
Type of Study
Treatment
Locations
Harmony Campus
Medical Center of the Rockies
Principal Investigator
Ethan Ellis
Study ID
Protocol Number: 19-6101
ClinicalTrials.gov: NCT03683030
Categories
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