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, including optimized procedural techniques and anti-coagulation therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
60
MRI's will be performed on all subjects at Enrollment and Pre-Discharge (Post Ablation). Subjects with a positive MRI (cerebral lesion) at the Pre-Discharge will undergo an MRI at the 1 month follow-up visit.
AZ Middelheim
Antwerp, Belgium
Imelda Ziekenhuis
Bonheiden, Belgium
Southlake Regional Health Center
Newmarket, Ontario, Canada
Herz- und Gefäß-Klinik
Bad Neustadt/Saale, Germany
New Asymptomatic Cerebral Embolic Lesions, Visualized as 'Bright Spots' on Post-ablation MRI.
An acute embolic lesion is defined as a focal hyper-intense area detected on the diffusion-weighted (DW) sequence, corresponding to a hyper-intense signal intensity in the fluid-attenuated inversion recovery (FLAIR) sequence, and also confirmed by apparent diffusion coefficient (ADC) mapping to rule out a shine-through artifact.
Time frame: Within 1-3 days post ablation
Acute Safety Events
Assess the number of procedure or device-related serious adverse events when applying best practices with PVAC.
Time frame: 30 days
Acute Efficacy, as Determined by Complete Pulmonary Vein Isolation (PVI) Per Subject.
The number of subjects with pulmonary vein isolation (PVI) at the end of ablation procedure. This will characterize if use of best practices during PVAC ablation negatively affects acute efficacy.
Time frame: Day 1 (End of Procedure)
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Praxisklinik - Herz- und Gefässe
Dresden, Germany
Clinica Pineta Grande
Castel Volturno, Italy
AZ Sint Antonius Ziekenhuis
Nieuwegein, Netherlands