Status:
COMPLETED
Evaluation of the Incidence of Cerebral Lesions Post Pulmonary Vein Ablation Catheter (PVAC)
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of the study is to determine the rate of diffusion weighted (DW)-MRI cerebral lesions following a Pulmonary Vein Ablation Catheter (PVAC) ablation procedure performed using best practices,...
Eligibility Criteria
Inclusion
- Subject is at least 18 years old
- Subject has been diagnosed with atrial fibrillation (AF)
- Subject is indicated for a pulmonary vein ablation using PVAC
- Subject (or subject's legally authorized representative) is able and and willing to give informed consent.
Exclusion
- Subject has permanent AF
- Subject has a left atrial thrombus detected on TEE
- Subject has had a prior left atrial ablation
- Subject has a intracardiac thrombus
- Subject is contraindicated for Warfarin (Coumadin)
- Subject has a cardiac valve prosthesis
- Subject has a significant congenital heart defect corrected or not including atrial septal defects or pulmonary vein abnormalities but not including minor PFO)
- Subject has presence of any pulmonary vein stents
- Subject has presence of any pre-existing pulmonary vein stenosis
- Subject has had a cerebral ischemic event (strokes or transient ischemic attacks \[TIA\]) which occurred during the 6 month interval preceding the Consent Date
- Subject is a woman known to be pregnant
- Subject is unwilling or unable to comply fully with study procedures and follow-up
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01520532
Start Date
March 1 2012
End Date
November 1 2012
Last Update
October 16 2018
Active Locations (7)
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1
AZ Middelheim
Antwerp, Belgium
2
Imelda Ziekenhuis
Bonheiden, Belgium
3
Southlake Regional Health Center
Newmarket, Ontario, Canada, L3Y 2P9
4
Herz- und Gefäß-Klinik
Bad Neustadt/Saale, Germany