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

Withdrawn before enrolling · Not applicable

Conditions studied: Typical Atrial Flutter, Risk Factors With Future Development of Atrial Flutter

In brief

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).

Key facts

Study ID

NCT01710150

Run by

University of Pennsylvania

People needed

0

Starts

2012-11-01

Expected to finish

2014-08-01

Last updated by the study team

2017-05-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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:
• prior remote history of AF (≤ 2 episodes ≥ 1 year from the date of evaluation for study participation),
• LA size > 4.0 cm,
• left ventricular ejection fraction (LVEF) ≤ 50%,
• hypertension, and/or 5) obstructive sleep apnea.

You may not qualify if…

• Subjects with documented ≥ 2 AF episodes within the preceding 6 months of enrollment,
• inability or unwillingness to take 6 weeks of oral anticoagulation after the procedure and
• failure to provide informed consent.

Where it is running

• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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