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Completed

NCT Number: NCT01520532

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AZ Middelheim, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

magnetic resonance imaging (MRI)

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

Evaluate Reduction in Asymptomatic Cerebral Embolism

Acronym: ERACE

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 30, 2012
Registry last updated
Oct 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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