Status:

WITHDRAWN

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

Lead Sponsor:

Valley Health System

Conditions:

Persistent Atrial Fibrillation

Eligibility:

All Genders

18-85 years

Phase:

PHASE4

Brief Summary

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 iso...

Detailed Description

Atrial fibrillation (AF) is the most common cardiac disorder currently affecting 2.3 million U.S. adults with an expected increase in incidence to 5.6 million by the year 2050. Randomized clinical tri...

Eligibility Criteria

Inclusion

  • Symptomatic persistent AF
  • Failure of class I antiarrhythmic drug or amiodarone to control AF

Exclusion

  • 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

Key Trial Info

Start Date :

May 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2013

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT01877473

Start Date

May 1 2013

End Date

September 1 2013

Last Update

June 17 2014

Active Locations (1)

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1

Valley Hospital

Ridgewood, New Jersey, United States, 07450