Pulmonary Vein Isolation To Reduce Future Risk Of Atrial Fibrillation In Patients Undergoing Typical Flutter



Status:Withdrawn
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:November 2012
End Date:August 2014

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Randomized Trial Comparing Long Term Occurrence of Atrial Arrhythmias Including Atrial Fibrillation (AF) and Thromboembolic Complications in Patients With Typical Atrial Flutter (AFLT) Undergoing Cavo-tricuspid Isthmus (CTI) Ablation Alone Versus CTI Ablation Combined With Pulmonary Vein Isolation (PVI).

The purpose is to compare long term occurrence of atrial arrhythmias including atrial
fibrillation (AF) and thromboembolic complications including cerebrovascular events (CVE) in
patients with typical atrial flutter (AFLT) undergoing cavo-tricuspid isthmus (CTI) ablation
alone versus CTI ablation combined with pulmonary vein isolation (PVI).

Typical Atrial Flutter (AFLT) is a common cardiac arrhythmia. Studies have demonstrated the
safety and superiority of ablation procedure over antiarrhythmic drug (AAD) therapy. Long
term freedom from typical AFLT has been consistently shown after successful ablation, but up
to 30% of these patients can experience new onset of a different arrhythmia i.e., Atrial
Fibrillation (AF). AF results from triggers in the back of the left upper chamber in the
heart (left atrium - LA). These triggers typically arise from in and around the opening of
the 4 veins (pulmonary veins - PVs) that bring blood from the lungs into the heart. The
highest incidence of AF in patients undergoing ablation for typical AFLT was observed where
the follow-up duration exceeded a year after the AFLT ablation. This would suggest that AF
development in patients undergoing typical AFLT ablation is progressive and inevitable.

Inclusion Criteria:

All patients with typical AFLT confirmed by a 12-lead ECG that are referred for ablation
and manifest ≥ 2 risk factors associated with future development of AF will be eligible to
participate in the study.

Risk factors for predicting future occurrence of AF will include:

1. prior remote history of AF (≤ 2 episodes ≥ 1 year from the date of evaluation for
study participation),

2. LA size > 4.0 cm,

3. left ventricular ejection fraction (LVEF) ≤ 50%,

4. hypertension, and/or 5) obstructive sleep apnea.

Exclusion Criteria:

1. Subjects with documented ≥ 2 AF episodes within the preceding 6 months of enrollment,

2. inability or unwillingness to take 6 weeks of oral anticoagulation after the
procedure and

3. failure to provide informed consent.
We found this trial at
1
site
3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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mi
from
Philadelphia, PA
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