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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 : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Atrial Fibrillation
Intervention Other: Magnetic Resonance Imaging (MRI)
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ablation
Hide Arm/Group Description Single-arm study, all subjects received a radio-frequency (RF) ablation with the goal of achieving Pulmonary Vein Isolation (PVI).
Period Title: Overall Study
Started 60 [1]
Completed 60
Not Completed 0
[1]
Subjects who underwent an ablation and had post-procedure MRI
Arm/Group Title Ablation
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants
60  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Female
19
  31.7%
Male
41
  68.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants
Canada 12
Belgium 13
Germany 12
Netherlands 12
Italy 11
1.Primary Outcome
Title New Asymptomatic Cerebral Embolic Lesions, Visualized as 'Bright Spots' on Post-ablation MRI.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subject who underwent an ablation and post-procedure MRI.
Arm/Group Title Ablation
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: participants
1
2.Secondary Outcome
Title Acute Safety Events
Hide Description Assess the number of procedure or device-related serious adverse events when applying best practices with PVAC.
Time Frame 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects who underwent an ablation and post-procedure MRI
Arm/Group Title Ablation
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: events
1
3.Secondary Outcome
Title Acute Efficacy, as Determined by Complete Pulmonary Vein Isolation (PVI) Per Subject.
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects who underwent ablation and post-procedure MRI.
Arm/Group Title Ablation
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: participants
60
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ablation
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Ablation
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ablation
Affected / at Risk (%) # Events
Total   1/60 (1.67%)    
Vascular disorders   
Bleeding  [1]  1/60 (1.67%)  1
Indicates events were collected by systematic assessment
[1]
Groin bleed requiring intervention (thrombin administration)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ablation
Affected / at Risk (%) # Events
Total   11/60 (18.33%)    
Vascular disorders   
Groin Bleed  [1]  11/60 (18.33%)  11
Indicates events were collected by systematic assessment
[1]
Mild groin bleed at location of sheath insertion
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Jay Kelley, Director of Clinical Research
Organization: Medtronic AF Solutions
Phone: +1.760.827.0076
Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT01520532     History of Changes
Other Study ID Numbers: MDT-AFS-ERACE
First Submitted: January 25, 2012
First Posted: January 30, 2012
Results First Submitted: December 10, 2012
Results First Posted: March 14, 2013
Last Update Posted: October 16, 2018