Signal Transfer of Atrial Fibrillation Data to Guide Human Treatment (STARLIGHT)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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The purpose of the study is to gather electrophysiological data using a multi-electrode mapping catheter during a clinically indicated cardiac ablation procedure for the treatment of persistent atrial fibrillation.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Permanent atrial fibrillation
Age 18 or above, or above legal age and willing and capable of giving informed consent specific to national law
Scheduled for a clinically indicated cardiac ablation for the treatment of persistent atrial fibrillation
Able to meet study requirements for follow-up visit
Permanent leads or presence of prosthetic or severely stenotic tricuspid or mitral valves
Active systemic infection or sepsis
Echocardiographically confirmed presence of thrombus
Atrial thrombus, myxoma, inter-atrial baffle patch or occluder device for those subjects in whom a transseptal approach is required
Subjects who cannot be anticoagulated or infused with heparinized saline
Heparin induced thrombocytopenia
Hemodynamic instability or shock
Atrial anatomy contradictory to catheter labeling or size indices
EF < 35%
Subjects with an active heart failure decompensation