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

This study has been withdrawn prior to enrollment.
(No enrollment)
Sponsor:
Information provided by (Responsible Party):
Jonathan Steinberg,MD, Valley Health System
ClinicalTrials.gov Identifier:
NCT01877473
First received: May 26, 2013
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Persistent Atrial Fibrillation
Procedure: Ablation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Valley Health System:

Primary Outcome Measures:
  • Freedom of atrial fibrillation/flutter [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: May 2013
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Reverse remodeling
Pretreatment with dofetilide or sotalol and restoration of sinus rhythm followed by PVI only ablation
Procedure: Ablation
Active Comparator: Standard ablation
PVI ablation with additional CFAE and/or linear LA ablation
Procedure: Ablation

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 trials have shown that ablation was superior to antiarrhythmic drug (AAD) in maintaining sinus rhythm among patients with symptomatic predominantly paroxysmal AF. However the results for catheter ablation of persistent AF is much lower and more variable, ranging between 20-80%. Moreover there is no agreed-upon standard ablation approach. Prior studies suggest that pulmonary vein isolation (PVI) alone has an unacceptably low success rate so most laboratories supplement this approach with additional lesion sets. These include complex atrial fractionated electrograms ("CAFÉ"), autonomic denervation, and linear left atrial ablation at the roof and mitral isthmus, in an empirical manner or stepwise approach. However, these strategies are time consuming and prone to proarrhythmia, namely post-ablation atrial tachycardias which can occur with an incidence ranging from < 5 to 50%.

The lower efficacy of PVI alone in persistent AF has been attributed to adverse electrical, molecular, and structural remodeling of the atria. Collectively, atrial remodeling decreases conduction velocity and the effective refractory period, and results in a shortened atrial wavelength, which increases the number and stability of reentrant wavelets. This can cause persistence of AF independent of a focal discharge. Standard PVI addresses the "focal discharge" or trigger from the PVs that initiates AF but not necessarily the underlying atrial substrate.

Based on these concepts, we hypothesized that successful atrial reverse remodeling by temporary AAD therapy would facilitate the performance of PVI alone in patients with persistent AF. The utilization of reverse remodeling to enhance the efficiency, efficacy and safety of ablation of AF has not been tested in a randomized clinical trial.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01877473

Locations
United States, New Jersey
Valley Hospital
Ridgewood, New Jersey, United States, 07450
Sponsors and Collaborators
Valley Health System
Investigators
Principal Investigator: Jonathan S Steinberg, MD Valley Health System/Columbia University
  More Information

No publications provided

Responsible Party: Jonathan Steinberg,MD, Director, Arrhythmia Institute, Valley Health System
ClinicalTrials.gov Identifier: NCT01877473     History of Changes
Other Study ID Numbers: VHS 12.0031
Study First Received: May 26, 2013
Last Updated: June 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Valley Health System:
atrial fibrillation
persistent AF
catheter ablation
duration of 7 days to one year
with symptoms and failure of at least one antiarrhythmic drug

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014