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Persistent Atrial Fibrillation | Comparison of Reverse Remodeling and PVI Versus CFAE and/or Linear Lesions and PVI for Persistent AF

Persistent Atrial Fibrillation research study

What is the primary objective of this study?

The hypothesis of this study is that by facilitating reverse atrial remodeling with maintenance of sinus rhythm in the weeks preceding ablation makes it feasible to perform a simple pulmonary vein isolation (PVI) with results equivalent or superior to more complex atrial ablation for patients with persistent AF.

Who is eligible to participate?

Inclusion Criteria: - Symptomatic persistent AF - Failure of class I antiarrhythmic drug or amiodarone to control AF Exclusion Criteria: - Previous proarrhythmia to class III AAD including excessive QT prolongation or torsade-de-pointes - Previous AF ablation procedure - Congestive heart failure (NYHA III-IV functional class) - Left ventricle ejection fraction less than 35% - Left atrial diameter >55 mm - Unwillingness to participate

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Persistent 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.

Procedure:Ablation

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.

Reverse remodelingPretreatment with dofetilide or sotalol and restoration of sinus rhythm followed by PVI only ablation

Standard ablationPVI ablation with additional CFAE and/or linear LA ablation

Study Status

Withdrawn

Start Date: May 2013

Completed Date: September 2013

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Freedom of atrial fibrillation/flutter

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Jonathan S Steinberg, MD

Lead Sponsor: Valley Health System

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01877473

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