The University of Chicago
Chicago, Illinois, 60637, United States
NCT Number: NCT03737838
The purpose of this study is to perform ultra-high density mapping of the left atrium (a chamber of the heart) using the the Rhythmia Mapping System and to determine whether additional ablation in areas of wavefront discontinuities identified by the map will reduce the likelihood of both atrial fibrillation and atrial flutter.
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Notify Me18 year and older
All sexes
Observational
Chicago, Illinois, 60637, United States
Catheter ablation (CA) is a class 1 indication for patients with symptomatic drug-refractory atrial fibrillation (AF). With standard pulmonary vein isolation (PVI), the success rate ranges from 60-80% in patients with paroxysmal AF. Despite PVI, certain patients have recurrent AF and often require a repeat ablation procedure.
There is no standard ablation strategy for patients who undergo repeat ablation for recurrent AF. The largest randomized trial to date comparing ablation strategies found that the addition of LA roof and mitral isthmus ablation lines or ablation of LA ganglia was no better than standard PVI. Moreover, the addition of ablation lines in the LA, if not complete, may be pro-arrhythmic and lead to the development of LA AFL, which is often more symptomatic that AF itself.
Ultra-high density mapping during sinus rhythm allows for rapid creation of isochronal late activation maps (ILAM) in patients with ventricular tachycardia. To date, creating ILAM of the LA has not been reported and it is not known whether additional ablation in these areas improves freedom from all atrial tachyarrhythmias at 1 year follow-up. Moreover, ablation at the deceleration zones and/or gaps identified using ultra-high density mapping is a promising strategy to improve ablation success and decrease the potential for recurrent AF.
The rationale of the study is two-fold.
Co-PIs:
Hemal Nayak, MD Guarav Upadhyay, MD Andrew Beaser, MD Zaid Aziz, MD
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
High density mapping of left atrium using Rhythmia mapping system to identify gaps in conduction and wavefront discontinuities (deceleration zones)
Time frame: Baseline to 1 year
Freedom from atrial arrhythmias
University of Chicago
Other
Propagation ANalysis for Arrhythmogenic Conduction Elimination to Prevent Atrial Flutter and Fibrillation
Acronym: PANACEA-AF
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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