Atrial Fibrillation
Conditions
Brief summary
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
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.
Interventions
OTHERAblation / MRI
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.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure rate of post-procedure asymptomatic cerebral embolic (ACE) as determined by MRI | 1-45 days post-ablation procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure acute procedural success | 0-1 days after procedure | 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) |
| Report procedure and/or device related serious adverse events using PVAC GOLD | 0-45 days post-ablation procedure | — |
Countries
Belgium, France, Germany, Hungary, Netherlands, United Kingdom
Outcome results
None listed