An interventional study of Radiofrequency ablation in Atrial Fibrillation, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-06-14.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Treatment
This study involves treatment for atrial fibrillation (AF)-the most common heart condition in the US-where the upper chambers of the heart beat very fast and in a disorganized manner. This can be felt as palpitations, tiredness, shortness of breath and passing out, plus can lead to stroke, damage to the heart muscle and a shorter life span. Study participants will receive a common treatment for atrial fibrillation called radiofrequency ablation (RFA), where small lesions or "burns" are made inside the heart to cut off the abnormal impulses that cause AF. The purpose of this study is to compare the effectiveness of three different common ablation strategies in patients with persistent or permanent AF. Subjects will be randomized (like drawing straws) to be treated with one of the three strategies to see if there is a difference in how well atrial fibrillation is controlled after treatment.
In most cases, AF originates where the pulmonary veins (PV) enter the left upper chamber of the heart, known as the left atrium (LA). Common to the procedure in each arm of the study is pulmonary vein isolation (PVI) or ablation of tissue around the pulmonary vein entrances. After PVI, the procedure continues with ablation in other areas of the LA where similar abnormal impulses are found. The three strategies for continuing with ablation after PVI are described in the "Arms" section below.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 166 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pulmonary vein isolation (PVI) combined with ablation of documented non-PV triggers of atrial fibrillation --- (sites away from the pulmonary veins where consistent abnormal impulses that can trigger AF are identified during the procedure)
Procedure: Radiofrequency ablation
PVI combined with ablation at documented sites of non-PV triggers, PLUS ablation at sites where non-PV triggers are commonly found
Procedure: Radiofrequency ablation
PVI combined with ablation at documented sites of non-PV triggers and ablation at sites in the left atrium that demonstrate disorganized electrical impulses called complex fractionated electrograms (CFE).
Procedure: Radiofrequency ablation
Special catheters are inserted into blood vessels in the groin, then advanced into the left atrium of the heart. Radiofrequency (heat) energy is applied to small areas of heart tissue where electrical impulses that generate AF are found.
Long-term (greater than 6 months) arrhythmia control in patients with persistent or permanent AF
Time frame: 6 - 12 months
This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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