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| ID | Type | Description | Link |
|---|---|---|---|
| 4-087-08 | Other Identifier | ethic's committee Charité Berlin |
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reason
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| Name | Class |
|---|---|
| German Federal Ministry of Education and Research | OTHER_GOV |
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The purpose of this prospective randomized single-center trial is to compare efficiency and safety of two pulmonary vein ablation systems in patients with symptomatic paroxysmal atrial fibrillation using the Arctic Front® versus the HD Mesh Ablator® catheter.
Primary objective:
• Efficacy of pulmonary vein isolation defined by achieving an exit block for all pulmonary veins per patient.
Secondary objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arctic Front® catheter | Active Comparator |
| |
| HD Mesh Ablator® catheter | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arctic Front® catheter vs. HD Mesh Ablator® catheter | Procedure | Pulmonary vein ablation in patients with symptomatic paroxysmal atrial fibrillation using the Arctic Front® catheter versus the HD Mesh Ablator® catheter |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of pulmonary vein isolation defined by achieving an exit block for all pulmonary veins per patient | During ablation procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain MRI | within 2 days after catheter ablation | |
| Detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain MRI | 6 months after catheter ablation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Schirdewan, MD | Department of Cardiology, Charité - University Medicine Berlin, Germany. | Principal Investigator |
| Jochen B Fiebach, MD | Center for Stroke Research Berlin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité, University Medicine Berlin, Campus Benjamin Franklin, Hindenburgdamm 30 | Berlin | 12200 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31992513 | Derived | Herm J, Schirdewan A, Koch L, Wutzler A, Fiebach JB, Endres M, Kopp UA, Haeusler KG. Impact of atrial fibrillation burden on cognitive function after left atrial ablation - Results of the MACPAF study. J Clin Neurosci. 2020 Mar;73:168-172. doi: 10.1016/j.jocn.2019.12.030. Epub 2020 Jan 25. | |
| 28243592 | Derived |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Determination of spontaneous recurrence rate of atrial fibrillation using a subcutaneously implanted loop recorder (Reveal XT®) | 1 year after catheter ablation |
| Characterization of non-neurologic major complications (death, atrial-esophageal fistula, pulmonary vein stenosis, pericardial tamponade) | within 1 month after catheter ablation |
| Rate of iatrogenic interatrial septal defects after transseptal puncture for left-sided atrial catheter ablation | 1 year after catheter ablation |
| Schirdewan A, Herm J, Roser M, Landmesser U, Endres M, Koch L, Haeusler KG. Loop Recorder Detected High Rate of Atrial Fibrillation Recurrence after a Single Balloon- or Basket-Based Ablation of Paroxysmal Atrial Fibrillation: Results of the MACPAF Study. Front Cardiovasc Med. 2017 Feb 13;4:4. doi: 10.3389/fcvm.2017.00004. eCollection 2017. |
| 23989301 | Derived | Herm J, Fiebach JB, Koch L, Kopp UA, Kunze C, Wollboldt C, Brunecker P, Schultheiss HP, Schirdewan A, Endres M, Haeusler KG. Neuropsychological effects of MRI-detected brain lesions after left atrial catheter ablation for atrial fibrillation: long-term results of the MACPAF study. Circ Arrhythm Electrophysiol. 2013 Oct;6(5):843-50. doi: 10.1161/CIRCEP.113.000174. Epub 2013 Aug 29. |
| 22913568 | Derived | Haeusler KG, Koch L, Herm J, Kopp UA, Heuschmann PU, Endres M, Schultheiss HP, Schirdewan A, Fiebach JB. 3 Tesla MRI-detected brain lesions after pulmonary vein isolation for atrial fibrillation: results of the MACPAF study. J Cardiovasc Electrophysiol. 2013 Jan;24(1):14-21. doi: 10.1111/j.1540-8167.2012.02420.x. Epub 2012 Aug 22. |
| 22523379 | Derived | Koch L, Haeusler KG, Herm J, Safak E, Fischer R, Malzahn U, Werncke T, Heuschmann PU, Endres M, Fiebach JB, Schultheiss HP, Schirdewan A. Mesh ablator vs. cryoballoon pulmonary vein ablation of symptomatic paroxysmal atrial fibrillation: results of the MACPAF study. Europace. 2012 Oct;14(10):1441-9. doi: 10.1093/europace/eus084. Epub 2012 Apr 20. |
| 21070885 | Derived | Haeusler KG, Koch L, Ueberreiter J, Coban N, Safak E, Kunze C, Villringer K, Endres M, Schultheiss HP, Fiebach JB, Schirdewan A. Safety and reliability of the insertable Reveal XT recorder in patients undergoing 3 Tesla brain magnetic resonance imaging. Heart Rhythm. 2011 Mar;8(3):373-6. doi: 10.1016/j.hrthm.2010.11.008. Epub 2010 Nov 9. |
| 20663131 | Derived | Haeusler KG, Koch L, Ueberreiter J, Endres M, Schultheiss HP, Heuschmann PU, Schirdewan A, Fiebach JB. Stroke risk associated with balloon based catheter ablation for atrial fibrillation: Rationale and design of the MACPAF Study. BMC Neurol. 2010 Jul 21;10:63. doi: 10.1186/1471-2377-10-63. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |