An interventional study of Pulmonary Vein Isolation procedure in Atrial Fibrillation, sponsored by University of Pennsylvania. Terminated at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-22.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Treatment
Pulmonary vein isolation (PVI) combined with empiric ablation of either common sites of non-PV triggers of Atrial Fibrillation (AF) and locations that may sustain stable AF sources should be more efficacious than PVI combined with ablation of only documented non-PV triggers of AF in achieving long-term arrhythmia control in patients with persistent or long standing persistent AF.
The AF ablation procedure has evolved considerably and currently the most accepted technique involves creation of circumferential Radiofrequency Ablation lesions around PV ostia (encircling wide areas around the left and right sided veins). We have found that targeting areas outside the pulmonary veins that trigger atrial premature beats of AF is important for optimizing the success of AF ablation. The methodology of additional lesion creation remains non-uniform, lacks mechanistic insights, and there is paucity of prospective randomized comparison on the long term efficacy and safety of various lesion combinations in achieving AF control. Our group recently conducted randomized study (RASTA Trial) that compared PVI combined with ablation of documented non-PV triggers (standard AF ablation strategy) of AF to two other strategies i.e. 1. PVI combined with empiric ablation at common non-PV trigger sites of AF, 2. PVI combined with ablation of locations demonstrating complex fractionated electrograms. In this study comprising 156 subjects with persistent and/or long standing persistent AF, the investigators found that the standard AF ablation strategy was as efficacious as PVI combined with empiric ablation at common non-PV trigger sites of AF and both of these approaches were significantly better than PVI combined with ablation of locations demonstrating complex fractionated electrograms. Our study also showed that when compared to the standard AF ablation strategy (PVI combined with ablation of documented non PV AF triggers), PVI combined with empiric ablation at common locations of AF triggers in the left and right atria showed 22% higher odds of achieving freedom from atrial arrhythmias and 33% higher odds of achieving arrhythmia control at one year. Although this difference may have been clinically meaningful, it did not reach statistical significance because this study was powered to test for a difference of ≥30% between groups. Thus, in the current proposal the investigators hope to show statistical difference in the outcomes between these two strategies by increasing the sample size which will provide adequate power to show a 20% difference in the primary outcome. Also, the investigators hope to enhance the outcome in the study arm (PVI combined with empiric ablation at common locations of AF triggers) by also targeting empirically locations in the left and right atria that have been shown in recent studies to be focal sources and rotors that maintain AF.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 56 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
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Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
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Exclusion Criteria:
Pulmonary Vein Isolation procedure combined with ablation of documented non-PV triggers of AF
Other: Pulmonary Vein Isolation procedure
Pulmonary Vein Isolation procedure combined with empiric ablation of common sites of non-PV triggers of AF and locations that may sustain AF sources on long term arrhythmia control
Other: Pulmonary Vein Isolation procedure
comparing the efficacy of PVI ablation vs PVI combined with empiric ablation
Also known as: PVI ablation procedure
Primary
Compare PVI strategies in group 1 (documented non-PV triggers of AF) to group 2 (PVI combined with empiric ablation of common sites) over 12 months to assess for recurrence of atrial fibrillation.
Time frame: 1 year
This study is terminated, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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