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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. Identifier: NCT01520532
Recruitment Status : Completed
First Posted : January 30, 2012
Results First Posted : March 14, 2013
Last Update Posted : October 16, 2018
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

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, including optimized procedural techniques and anti-coagulation therapy.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Other: Magnetic Resonance Imaging (MRI) Not Applicable

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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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Ablation 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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Acute Safety Events [ Time Frame: 30 days ]
    Assess the number of procedure or device-related serious adverse events when applying best practices with PVAC.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01520532

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AZ Middelheim
Antwerpen, Belgium
Imelda Ziekenhuis
Bonheiden, Belgium
Canada, Ontario
Southlake Regional Health Center
Newmarket, Ontario, Canada, L3Y 2P9
Herz- und Gefäß-Klinik
Bad Neustadt/Saale, Germany
Praxisklinik - Herz- und Gefässe
Dresden, Germany
Clinica Pineta Grande
Castel Volturno, Italy
AZ Sint Antonius Ziekenhuis
Nieuwegein, Netherlands
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
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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

Publications of Results:
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Responsible Party: Medtronic Cardiac Rhythm and Heart Failure Identifier: NCT01520532     History of Changes
Other Study ID Numbers: MDT-AFS-ERACE
First Posted: January 30, 2012    Key Record Dates
Results First Posted: March 14, 2013
Last Update Posted: October 16, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes