Evaluate Reduction in Asymptomatic Cerebral Embolism

Completed

Conditions: heart rhythm disorders - atrial fibrillation
10007521

Registration Number: NL-OMON37562

Lead Sponsor: Medtronic B.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

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 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 an 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 TIAs) which occurred during the 6 month interval preceding the Consent Date
Subject will undergo additional left atrial ablations with catheters other than a PVAC.
Subject is a woman known to be pregnant
Subject is unable or unwilling to participate with study procedures

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Demonstrate that use of best PVAC ablation practices, will reduce the cerebral<br /><br>lesion rate to less than the published rate of 38%.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The key secondary objectives are intended to provide additional information on<br /><br>the performance of the GENius* Multi-Channel RF Generator. There will be no<br /><br>established performance requirements related to these secondary objectives<br /><br>required. The secondary objectives are as follows:<br /><br>• Assess the use of best practices during PVAC® ablation and the rate of major<br /><br>or minor complications.<br /><br>• Characterize the use of best practices during PVAC® ablation to reduce<br /><br>cerebral lesion rates will not negatively affect acute efficacy.<br /><br>• Collect high resolution generator data to develop a validation database to<br /><br>test future algorithms for automatic detection of microemboli.</p><br>