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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ablation / MRI | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ablation / MRI | Other | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Measure acute procedural success | Acute procedural success is defined as:
| 0-1 days after procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZNA Middelheim | Antwerp | Belgium | ||||
| Hopital Cardiolgique du Haut-Leveque |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26826134 | Derived | De Greef Y, Dekker L, Boersma L, Murray S, Wieczorek M, Spitzer SG, Davidson N, Furniss S, Hocini M, Geller JC, Csanadi Z; PRECISION GOLD investigators. Low rate of asymptomatic cerebral embolism and improved procedural efficiency with the novel pulmonary vein ablation catheter GOLD: results of the PRECISION GOLD trial. Europace. 2016 May;18(5):687-95. doi: 10.1093/europace/euv385. Epub 2016 Jan 29. |
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|
| Report procedure and/or device related serious adverse events using PVAC GOLD |
| 0-45 days post-ablation procedure |
| Pessac |
| France |
| Zentraklinik Bad Berka | Bad Berka | Germany |
| St. Agnes Hospital Bocholt | 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 |
| Freeman Hospital | Newcastle upon Tyne | United Kingdom |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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