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ClinicalTrials.gov Identifier: NCT02830750
Recruitment Status :
First Posted : July 13, 2016
Last Update Posted : April 26, 2018
Beacon Medical Group
Brigham and Women's Hospital
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Prospective data collection of patients undergoing Atrial Fibrillation Ablation.
Condition or disease
Clinicians who have experience using low dose fluoroscopy including use of Carto Mapping system will consent patients to allow data collection and a 12 month f/up visit to track adverse events. Clinicians will follow a protocol which will be similar to their standard of care for ablations.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients who have persistant or paroxysmal atrial fibrillation
Patient meets accepted AHA/ACC/HRS guideline indications for catheter ablation of paroxysmal or persistent AF
First or subsequent ablation procedures may be included
Known venous malformations or implanted instrumentation (IVC filter)
Known PV stenosis
Unable to provide consent
H/O mechanical mitral valve replacement (unable to rely on EA mapping only)
Documented left atrial thrombus
Prior ASD repair Pregnancy
EF less than 35%
CHF within 90 daysRecent MI or coronary revascularization within 90 days
NOTE: H/O implanted pacemaker or ICD with transvenous leads will NOT be an exclusion criteria, but we will track patients treated with pre-existing transvenous leads with the hypothesis that although fluoroscopy use will be higher in these patients compared to those without leads, but still lower than conventionally treated patients.
Patients who are undergoing non- standard of care ablations ie, Cyro or FIRM ablations