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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Magnetic Resonance Imaging (MRI)
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AZ Middelheim
  • Imelda Ziekenhuis
  • Southlake Regional Health Center
  • Herz- und Gefäß-Klinik
  • Praxisklinik - Herz- und Gefässe
  • Clinica Pineta Grande
  • AZ Sint Antonius Ziekenhuis

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Ablation

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Acute Safety Events
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.
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.

Full Information

First Posted
January 25, 2012
Last Updated
September 17, 2018
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT01520532
Brief Title
Evaluation of the Incidence of Cerebral Lesions Post Pulmonary Vein Ablation Catheter (PVAC)
Acronym
ERACE
Official Title
Evaluate Reduction in Asymptomatic Cerebral Embolism
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ablation
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Magnetic Resonance Imaging (MRI)
Intervention Description
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 Measure Information:
Title
New Asymptomatic Cerebral Embolic Lesions, Visualized as 'Bright Spots' on Post-ablation MRI.
Description
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.
Time Frame
Within 1-3 days post ablation
Secondary Outcome Measure Information:
Title
Acute Safety Events
Description
Assess the number of procedure or device-related serious adverse events when applying best practices with PVAC.
Time Frame
30 days
Title
Acute Efficacy, as Determined by Complete Pulmonary Vein Isolation (PVI) Per Subject.
Description
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.
Time Frame
Day 1 (End of Procedure)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yves De Greef, MD
Organizational Affiliation
AZ Middelheim
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lucas Boersma, MD
Organizational Affiliation
AZ Sint Antonius Ziekenhuis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Deneke, MD
Organizational Affiliation
Krankenhaus Porz am Rheim
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stefano Nardi, MD
Organizational Affiliation
Pineta Grande Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Atul Verma, MD
Organizational Affiliation
Southlake Regional health Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stefan G Spitzer, MD
Organizational Affiliation
Praxisklinik Herz- und Gefässe
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Philippe Debruyne, MD
Organizational Affiliation
Imelda Hospital, Bonheiden
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ Middelheim
City
Antwerpen
Country
Belgium
Facility Name
Imelda Ziekenhuis
City
Bonheiden
Country
Belgium
Facility Name
Southlake Regional Health Center
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2P9
Country
Canada
Facility Name
Herz- und Gefäß-Klinik
City
Bad Neustadt/Saale
Country
Germany
Facility Name
Praxisklinik - Herz- und Gefässe
City
Dresden
Country
Germany
Facility Name
Clinica Pineta Grande
City
Castel Volturno
Country
Italy
Facility Name
AZ Sint Antonius Ziekenhuis
City
Nieuwegein
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
23983245
Citation
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.
Results Reference
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Evaluation of the Incidence of Cerebral Lesions Post Pulmonary Vein Ablation Catheter (PVAC)

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