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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?

Atrial Fibrillation

Study Interventions

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

Study Arms

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

Study Status

Withdrawn

Start Date: December 2011

Completed Date: January 2014

Phase: Phase 4

Type: Interventional

Design:

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.

More information:https://clinicaltrials.gov/show/NCT01505296

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