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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: Magnetic Resonance Imaging (MRI)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 1-3 days post ablation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Safety Events	Assess the number of procedure or device-related serious adverse events when applying best practices with PVAC.	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.	Day 1 (End of Procedure)

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Investigators: 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 and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: January 25, 2012
• First Submitted That Met QC Criteria: January 27, 2012
• First Posted (Estimate): January 30, 2012

Study Record Updates

• Last Update Posted (Actual): October 16, 2018
• Last Update Submitted That Met QC Criteria: September 17, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: MDT-AFS-ERACE