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

Persistent Atrial Fibrillation Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01877473
• Other study ID #: VHS 12.0031
• Status: Withdrawn
• Phase: Phase 4
• First received: May 26, 2013
• Last updated: June 16, 2014
• Start date: May 2013
• Est. completion date: September 2013

Study information

• Verified date: June 2014
• Source: Valley Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 isolation (PVI) with results equivalent or superior to more complex atrial ablation for patients with persistent AF.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Procedure:
• Ablation

Locations

Country	Name	City	State
United States	Valley Hospital	Ridgewood	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Valley Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom of atrial fibrillation/flutter		One year	Yes