Evaluation of the Incidence of Cerebral Lesions Post Pulmonary Vein Ablation Catheter (PVAC) (ERACE)
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 Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Evaluate Reduction in Asymptomatic Cerebral Embolism|
- New Asymptomatic Cerebral Embolic Lesions, Visualized as 'Bright Spots' on Post-ablation MRI. [ Time Frame: Within 1-3 days post ablation ] [ Designated as safety issue: No ]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.
- Acute Safety Events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]Assess the number of procedure or device-related serious adverse events when applying best practices with PVAC.
- Acute Efficacy, as Determined by Complete Pulmonary Vein Isolation (PVI) Per Subject. [ Time Frame: Day 1 (End of Procedure) ] [ Designated as safety issue: No ]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.
|Study Start Date:||March 2012|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Other: Magnetic Resonance Imaging (MRI)
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.
|Southlake Regional Health Center|
|Newmarket, Ontario, Canada, L3Y 2P9|
|Herz- und Gefäß-Klinik|
|Bad Neustadt/Saale, Germany|
|Praxisklinik - Herz- und Gefässe|
|Clinica Pineta Grande|
|Castel Volturno, Italy|
|AZ Sint Antonius Ziekenhuis|
|Principal Investigator:||Yves De Greef, MD||AZ Middelheim|
|Principal Investigator:||Lucas Boersma, MD||AZ Sint Antonius Ziekenhuis|
|Principal Investigator:||Thomas Deneke, MD||Krankenhaus Porz am Rheim|
|Principal Investigator:||Stefano Nardi, MD||Pineta Grande Hospital|
|Principal Investigator:||Atul Verma, MD||Southlake Regional Health Center|
|Principal Investigator:||Stefan G Spitzer, MD||Praxisklinik Herz- und Gefässe|
|Principal Investigator:||Philippe Debruyne, MD||Imelda Hospital, Bonheiden|