PRECISION GOLD Post Market Study in Europe of Pulmonary Vein Ablation Catheter (PVAC GOLD)

Study Overview
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Brief Summary
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PRECISION GOLD is a prospective, multi-center, single arm, unblinded interventional post market clinical study conducted in Europe. The purpose of the study is to evaluate asymptomatic cerebral embolic (ACE) lesions in subjects with symptomatic paroxysmal atrial fibrillation undergoing ablation with the Pulmonary Vein Ablation Catheter (PVAC) GOLD.

Detailed Description
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10-12 centers in Europe will enroll up to 56 subjects who meet the inclusion/exclusion criteria and provide consent to participate in the study. Subjects will undergo an ablation for paroxysmal AF with the Medtronic PVAC GOLD (CE-Mark). To assess for ACE lesions, pre- and post-ablation procedure cerebral MRIs will be done along with a neurological exam (Mini Mental State Exam). Subjects will be followed for 1 month post-procedure when a repeat MRI and neurological exam will be conducted if the subject had a positive MRI at pre-hospital discharge.

Official Title
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Phased RF Evaluation of Acute Pulmonary Vein Isolation in Paroxysmal AF With New GENius UI and PVAC GOLD

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Other: Ablation / MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic AF (>/=2 recurrent AF episodes that self terminate or AF </=48 hours that are cardioverted) Documentation of >/=1 paroxysmal AF events within past year AF symptoms (e.g. palpitations, fatigue, exertional dyspnea, effort intolerance) Prescribed to vitamin K antagonist (e.g. warfarin/coumadin) Age 18-70 years old Clinically indicated for a pulmonary vein ablation Willing and able to give informed consent Willing, able and committed to participate in all study required activities for the duration of the study Exclusion Criteria: Diagnosis of persistent or permanent AF Prior left atrial ablation Presence of intracardiac thrombus Contraindicated for vitamin K antagonist Prescribed to direct thrombin or factor inhibitors (e.g. dabigatran, rivaroxaban) Prescribed to any investigational drug that may confound the study results Cardiac valve prosthesis Significant congenital heart defect (corrected or not) Pulmonary vein stents Pre-existing pulmonary vein stenosis Cerebral ischemic event (e.g. stroke, TIA) that occurred within 6 months of study consent date If female - pregnancy Participation in any other cardiovascular clinical study Contraindicated for MRI Active sepsis Blood clotting abnormalities (genetic) Presence of left atrial myxoma Venous filtering device (e.g. Greenfield filter) Invasive cardiac procedure in past 90 days

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ablation / MRI<br>All subjects will undergo a standard of care ablation procedure for paroxysmal AF with the CE-Marked PVAC GOLD catheter. MRIs will be performed on all subjects at Enrollment and Pre-Discharge (Post Ablation). Subjects with a positive MRI (cerebral lesion) at Pre-Discharge will undergo another MRI at the 1 month follow-up visit. | Other: Ablation / MRI<br>* All subjects will undergo a standard of care ablation procedure for paroxysmal AF with the CE-Marked PVAC GOLD catheter. MRIs will be performed on all subjects at Enrollment and Pre-Discharge (Post Ablation). Subjects with a positive MRI (cerebral lesion) at Pre-Discharge will undergo another MRI at the 1 month follow-up visit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure rate of post-procedure asymptomatic cerebral embolic (ACE) as determined by MRI | Pre- and post-ablation MRIs will be evaluated for ACE lesions. If the post-ablation MRI (within 16-72 hours) is positive for ACE, a repeat MRI will be completed at the 1 month visit. | 1-45 days post-ablation procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure acute procedural success | Acute procedural success is defined as: Only PVAC GOLD catheters used to achieve pulmonary vein (PV) isolation All accessible PVs were isolated (entrance block) Sinus rhythm is restored at the end of the ablation procedure (with or without cardioversion) | 0-1 days after procedure | 
| Report procedure and/or device related serious adverse events using PVAC GOLD |  | 0-45 days post-ablation procedure |