Comparison of Reverse Remodeling and PVI Versus CFAE and/or Linear Lesions and PVI for Persistent AF
| Status: | Recruiting |
|---|---|
| Conditions: | Atrial Fibrillation |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 5/5/2014 |
| Start Date: | May 2013 |
| Contact: | Jonathan S Steinberg, MD |
| Email: | jss7@columbia.edu |
| Phone: | 212-432-7837 |
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.
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.
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.
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.
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
We found this trial at
3
sites
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