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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier:
NCT01520532
First received: January 25, 2012
Last updated: September 10, 2013
Last verified: February 2013
  Purpose

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 Intervention
Atrial Fibrillation
Other: Magnetic Resonance Imaging (MRI)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Evaluate Reduction in Asymptomatic Cerebral Embolism

Resource links provided by NLM:


Further study details as provided by Medtronic Atrial Fibrillation Solutions:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 60
Study Start Date: March 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01520532

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

Publications:
Responsible Party: Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier: NCT01520532     History of Changes
Other Study ID Numbers: MDT-AFS-ERACE
Study First Received: January 25, 2012
Results First Received: December 10, 2012
Last Updated: September 10, 2013
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Atrial Fibrillation
Intracranial Embolism
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Intracranial Embolism and Thrombosis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Thromboembolism
Embolism and Thrombosis
Thrombosis

ClinicalTrials.gov processed this record on April 15, 2014