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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ablation | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Imaging (MRI) | Other | MRI's will be performed on all subjects at Enrollment and Pre-Discharge (Post Ablation). Subjects with a positive MRI (cerebral lesion) at the Pre-Discharge will undergo an MRI at the 1 month follow-up visit. |
| Measure | Description | Time Frame |
|---|---|---|
| New Asymptomatic Cerebral Embolic Lesions, Visualized as 'Bright Spots' on Post-ablation MRI. | An acute embolic lesion is defined as a focal hyper-intense area detected on the diffusion-weighted (DW) sequence, corresponding to a hyper-intense signal intensity in the fluid-attenuated inversion recovery (FLAIR) sequence, and also confirmed by apparent diffusion coefficient (ADC) mapping to rule out a shine-through artifact. | Within 1-3 days post ablation |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Safety Events | Assess the number of procedure or device-related serious adverse events when applying best practices with PVAC. | 30 days |
| Acute Efficacy, as Determined by Complete Pulmonary Vein Isolation (PVI) Per Subject. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yves De Greef, MD | AZ Middelheim | Principal Investigator |
| Lucas Boersma, MD | AZ Sint Antonius Ziekenhuis | Principal Investigator |
| Thomas Deneke, MD | Krankenhaus Porz am Rheim | Principal Investigator |
| Stefano Nardi, MD | Pineta Grande Hospital | Principal Investigator |
| Atul Verma, MD | Southlake Regional health Center | Principal Investigator |
| Stefan G Spitzer, MD | Praxisklinik Herz- und Gefässe | Principal Investigator |
| Philippe Debruyne, MD | Imelda Hospital, Bonheiden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Middelheim | Antwerp | Belgium | ||||
| Imelda Ziekenhuis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23983245 | Result | Verma A, Debruyne P, Nardi S, Deneke T, DeGreef Y, Spitzer S, Balzer JO, Boersma L; ERACE Investigators. Evaluation and reduction of asymptomatic cerebral embolism in ablation of atrial fibrillation, but high prevalence of chronic silent infarction: results of the evaluation of reduction of asymptomatic cerebral embolism trial. Circ Arrhythm Electrophysiol. 2013 Oct;6(5):835-42. doi: 10.1161/CIRCEP.113.000612. Epub 2013 Aug 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ablation | Single-arm study, all subjects received a radio-frequency (RF) ablation with the goal of achieving Pulmonary Vein Isolation (PVI). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ablation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | New Asymptomatic Cerebral Embolic Lesions, Visualized as 'Bright Spots' on Post-ablation MRI. | An acute embolic lesion is defined as a focal hyper-intense area detected on the diffusion-weighted (DW) sequence, corresponding to a hyper-intense signal intensity in the fluid-attenuated inversion recovery (FLAIR) sequence, and also confirmed by apparent diffusion coefficient (ADC) mapping to rule out a shine-through artifact. | All subject who underwent an ablation and post-procedure MRI. | Posted | Number | participants | Within 1-3 days post ablation |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ablation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Vascular disorders | Systematic Assessment | Groin bleed requiring intervention (thrombin administration) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Groin Bleed | Vascular disorders | Systematic Assessment | Mild groin bleed at location of sheath insertion |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jay Kelley, Director of Clinical Research | Medtronic AF Solutions | +1.760.827.0076 | jay.l.kelley@medtronic.com |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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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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The number of subjects with pulmonary vein isolation (PVI) at the end of ablation procedure. This will characterize if use of best practices during PVAC ablation negatively affects acute efficacy.
| Day 1 (End of Procedure) |
| Bonheiden |
| Belgium |
| Southlake Regional Health Center | Newmarket | Ontario | L3Y 2P9 | Canada |
| Herz- und Gefäß-Klinik | Bad Neustadt/Saale | Germany |
| Praxisklinik - Herz- und Gefässe | Dresden | Germany |
| Clinica Pineta Grande | Castel Volturno | Italy |
| AZ Sint Antonius Ziekenhuis | Nieuwegein | Netherlands |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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| Secondary | Acute Safety Events | Assess the number of procedure or device-related serious adverse events when applying best practices with PVAC. | All subjects who underwent an ablation and post-procedure MRI | Posted | Number | events | 30 days |
|
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| Secondary | Acute Efficacy, as Determined by Complete Pulmonary Vein Isolation (PVI) Per Subject. | The number of subjects with pulmonary vein isolation (PVI) at the end of ablation procedure. This will characterize if use of best practices during PVAC ablation negatively affects acute efficacy. | All subjects who underwent ablation and post-procedure MRI. | Posted | Number | participants | Day 1 (End of Procedure) |
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| 1 |
| 60 |
| 11 |
| 60 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |