PVI Using Cryoablation Alone in Paroxysmal AF Patients Converted From Persistent AF With Dofetilide (ABLATE)
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|ClinicalTrials.gov Identifier: NCT01877486|
Recruitment Status : Withdrawn (funding not available)
First Posted : June 13, 2013
Last Update Posted : October 4, 2016
|Condition or disease||Intervention/treatment|
|Paroxysmal Atrial Fibrillation Persistent Atrial Fibrillation||Procedure: Ablation|
Pulmonary vein isolation is now considered a cornerstone of all atrial fibrillation (AF) ablation procedures. In patients with paroxysmal AF, pulmonary vein isolation alone is usually sufficient. The cryoballoon is now FDA approved to achieve PVI in patients with paroxysmal AF.
Although no ablation system is yet approved in patients with persistent AF, these patients are increasingly undergoing ablation. Many investigators feel that these patients have more atrial disease and thus PVI alone is insufficient in these patients. As a result, it is common for these patients to undergo additional ablation, which is often quite extensive and exposes patients to proarrhythmia. Commonly utilized strategies include linear lesions (left atrial roof; mitral isthmus line), ablation of complex fractionated atrial electrograms (CFAEs), left atrial appendage isolation and/or even right atrial ablation. For years, the investigators have been concerned about the adverse effects of this additional ablation. The investigators postulated that the "answer" is not more ablation but trying to "reverse remodel" patients with persistent AF back to a paroxysmal form, whereby PVI alone would again be justified and sufficient. The efficacy of such a strategy has previously been demonstrated.
In brief, the investigators start patients with persistent AF on dofetilide 3 months prior to scheduled ablation. In 96% of patients, AF either suppresses completely or is transformed into a paroxysmal pattern. The net effect is "reverse remodeling" of the left atria. The investigators have confirmed this by using a reduction in P wave duration as a surrogate of remodeling. At the ablation procedure, the investigators perform PVI alone.
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Pulmonary Vein Isolation Using Cryoablation Alone in Paroxysmal Atrial Fibrillation Patients Converted From Persistent Atrial Fibrillation With Dofetilide|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||December 2016|
After pre-treatment with dofetilide and conversion of persistent AF to sinus rhythm, performance of PVI using cryoballoon
Pulmonary vein isolation following dofetilide
- Freedom from atrial fibrillation/flutter [ Time Frame: One year ]As assessed by one week Holters and symptoms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01877486
|United States, New Jersey|
|Ridgewood, New Jersey, United States, 07450|
|Principal Investigator:||Jonathan S Steinberg, MD||University of Rochester|