Evaluation of the Incidence of Cerebral Lesions Post Pulmonary Vein Ablation Catheter (PVAC) (ERACE)
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01520532|
Recruitment Status : Completed
First Posted : January 30, 2012
Results First Posted : March 14, 2013
Last Update Posted : September 19, 2013
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Other: Magnetic Resonance Imaging (MRI)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Evaluate Reduction in Asymptomatic Cerebral Embolism|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
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.
- New Asymptomatic Cerebral Embolic Lesions, Visualized as 'Bright Spots' on Post-ablation MRI. [ Time Frame: Within 1-3 days post ablation ]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 ]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) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01520532
|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|