Atrial Fibrillation | Catheter Ablation for Recently Diagnosed Paroxysmal Atrial Fibrillation
Atrial Fibrillation research study
What is the primary objective of this study?
The objective is to compare the progression of Atrial Fib (AF) burden by continuous monitoring in patients with recently diagnosed paroxysmal AF treated by catheter ablation (PVI) versus anti-arrhythmic drug (AAD) therapy.
Who is eligible to participate?
Inclusion Criteria: - Patients with recently diagnosed paroxysmal AF who are eligible to receive specific rhythm control therapy Exclusion Criteria: - Previous treatment with Class IC or class III AAD - Previous AF ablation procedure - Congestive heart failure (NYHA III-IV functional class) - Left Ventricle ejection fraction less than 35% - Left atrial diameter > 55mm - Unwillingness to participate
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Antiarrhythmic drugpropafenone, flecainide, sotalol, dofetilide
Procedure:Catheter ablationComplete PVI
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Antiarrhythmic drugClass I or III antiarrhythmic drug
Catheter ablationPulmonary vein isolation
Start Date: December 2011
Completed Date: January 2014
Phase: Phase 4
Primary Outcome: Percentage of AF burden
Secondary Outcome: All-death death
Study sponsors, principal investigator, and references
Principal Investigator: Jonathan Steinberg, MD
Lead Sponsor: Valley Health System
Collaborator: Biosense Webster, Inc.