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Evaluation of the Incidence of Cerebral Lesions Post Pulmonary Vein Ablation Catheter (PVAC) (ERACE)

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ClinicalTrials.gov Identifier: NCT01520532
Recruitment Status : Completed
First Posted : January 30, 2012
Results First Posted : March 14, 2013
Last Update Posted : September 19, 2013
Information provided by (Responsible Party):
Medtronic Atrial Fibrillation Solutions

January 25, 2012
January 30, 2012
December 10, 2012
March 14, 2013
September 19, 2013
March 2012
November 2012   (Final data collection date for primary outcome measure)
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.
Evidence of cerebral lesion post ablation confirmed by non-investigational MRI. [ Time Frame: Within 1-3 days post ablation ]
Complete list of historical versions of study NCT01520532 on ClinicalTrials.gov Archive Site
  • 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.
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Evaluation of the Incidence of Cerebral Lesions Post Pulmonary Vein Ablation Catheter (PVAC)
Evaluate Reduction in Asymptomatic Cerebral Embolism
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.
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Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Atrial Fibrillation
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.
Intervention: Other: Magnetic Resonance Imaging (MRI)
Verma A, Debruyne P, Nardi S, Deneke T, DeGreef Y, Spitzer S, Balzer JO, Boersma L; ERACE Investigators. Evaluation and reduction of asymptomatic cerebral embolism in ablation of atrial fibrillation, but high prevalence of chronic silent infarction: results of the evaluation of reduction of asymptomatic cerebral embolism trial. Circ Arrhythm Electrophysiol. 2013 Oct;6(5):835-42. doi: 10.1161/CIRCEP.113.000612. Epub 2013 Aug 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
November 2012
November 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   Germany,   Italy,   Netherlands
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Medtronic Atrial Fibrillation Solutions
Medtronic Atrial Fibrillation Solutions
Not Provided
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
Medtronic Atrial Fibrillation Solutions
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP