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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
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.
ZNA Middelheim
Antwerp, Belgium
Hopital Cardiolgique du Haut-Leveque
Pessac, France
Zentraklinik Bad Berka
Bad Berka, Germany
St. Agnes Hospital Bocholt
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.
Time frame: 1-45 days post-ablation procedure
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)
Time frame: 0-1 days after procedure
Report procedure and/or device related serious adverse events using PVAC GOLD
Time frame: 0-45 days post-ablation procedure
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Bocholt, Germany
Zentrum fuer klinische Pruefungen in der Facharztzentrum Dresden-Neustadt GbR
Dresden, Germany
Debrecen University
Debrecen, Hungary
Catharina Hospital
Eindhoven, Netherlands
St. Antonius Hospital
Nieuwegein, Netherlands
Eastbourne District General Hospital
Eastbourne, United Kingdom
University Hospital of South Manchester
Manchester, United Kingdom
...and 1 more locations