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

Medtronic

Status

Completed

Conditions

Atrial Fibrillation

Treatments

Other: Magnetic Resonance Imaging (MRI)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01520532

MDT-AFS-ERACE

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No 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