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The required number of endpoints will be obtained with a sample size lower than initially planned.
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| Name | Class |
|---|---|
| University Hospital Heidelberg | OTHER |
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The REDUCE-TE Pilot study is an international, multicenter, prospective, single arm study to compare the AlCath Flux eXtra Gold ablation catheter regarding the prevention of new subclinical cerebral thromboembolic lesions after Pulmonary Vein Isolation to historical data from the literature.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients | Experimental | All patients undergo cerebral Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI), Transesophageal (or Intracardial) Echocardiography and paperbased neurocognitive testing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cerebral Diffusion-Weighted Magnetic Resonance Imaging | Device | Patients undergo a cerebral Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Thromboembolic lesions | The occurrence of one or more new subclinical cerebral thromboembolic lesions after Pulmonary Vein Isolation assessed by Diffusion-Weighted MRI | 1-3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Neurocognitive status | To assess the impact of PVI on the patient's neurocognitive status measured by a testing battery including the STATE questionnaire, d2 test of attention, visual part of the visual and verbal memory test (VVM2) and Montreal Cognitive Assessment (MOCA) subtest | Baseline, 1-3 days and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Acute procedural success rate | Acute procedural success of Pulmonary Vein Isolation, defined as electrical isolation of all Pulmonary Veins (entrance block) | During ablation |
| Success of Pulmonary Vein Isolation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dipen Shah, Prof. Dr. | Hôpitaux Universitaires de Genève, Switzerland | Study Chair |
| Boris Schmidt, PD Dr. | Cardioangiologisches Centrum Bethanien, Germany | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ceske Budejovice Hospital | České Budějovice | Czechia | ||||
| Institute for Clinical and Experimental Medicine (IKEM) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23875670 | Background | Akca F, Zima E, Vegh EM, Szeplaki G, Skopal J, Hubay M, Lendvai Z, Merkely B, Szili-Torok T. Radiofrequency ablation at low irrigation flow rates using a novel 12-hole gold open-irrigation catheter. Pacing Clin Electrophysiol. 2013 Nov;36(11):1373-81. doi: 10.1111/pace.12215. Epub 2013 Jul 22. | |
| 23100094 | Background |
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| Transesophageal Echocardiography | Device | Patients undergo a Transesophageal Echocardiography prior to the ablation itself |
|
|
| Paperbased neurocognitive testing | Other | To assess the impact of PVI on the patient's neurocognitive status |
|
|
| Peri-procedural serious adverse events |
Any serious adverse event occurring during the ablation procedure and within 24 hours from completion of the procedure |
| Within 24 hours after ablation |
| Post-procedural clinical TE events | Composite endpoint: Occurrence of Transient Ischemic Attack and/or Ischemic Stroke and/or Systemic Embolism during the three months post-ablation period (excluding peri-procedural events) | 3 months period |
Three months ablation success, defined as freedom from symptomatic AF recurrences off antiarrhythmic drug therapy assessed to three-month follow-up
| 3 months |
| Prague |
| Czechia |
| Kerckhoff-Klinik | Bad Nauheim | Germany |
| Herz- und Diabeteszentrum NRW | Bad Oeynhausen | Germany |
| Charité Campus Benjamin Franklin | Berlin | Germany |
| Charité Campus Virchow | Berlin | Germany |
| Cardioangologisches Centrum Bethanien (CCB) | Frankfurt am Main | Germany |
| Universität Leipzig | Leipzig | Germany |
| Deutsches Herzzentrum München des Freistaates Bayern | Munich | Germany |
| Peter Osypka Herzzentrum München | Munich | Germany |
| Semmelweis Medical University | Budapest | Hungary |
| OLVG - Onze Lieve Vrouwe Gasthuis | Amsterdam | Netherlands |
| Haga Ziekenhuis | The Hague | Netherlands |
| Hôpitaux Universitaires de Genève | Geneva | Switzerland |
| Balazs T, Laczko R, Bognar E, Akman S, Nagy P, Zima E, Dobranszky J, Szili-Torok T. Ablation time efficiency and lesion volume - in vitro comparison of 4 mm, non irrigated, gold- and platinum-iridium-tip radiofrequency ablation catheters. J Interv Card Electrophysiol. 2013 Jan;36(1):13-8; discussion 18. doi: 10.1007/s10840-012-9743-9. Epub 2012 Oct 26. |
| 22429859 | Background | Linhart M, Liberman I, Schrickel JW, Mittmann-Braun EL, Andrie R, Stockigt F, Kreuz J, Nickenig G, Lickfett LM. Superiority of gold versus platinum irrigated tip catheter ablation of the pulmonary veins and the cavotricuspid isthmus: a randomized study comparing tip temperatures and cooling flow requirements. J Cardiovasc Electrophysiol. 2012 Jul;23(7):717-21. doi: 10.1111/j.1540-8167.2011.02267.x. Epub 2012 Mar 19. |
| 20876601 | Background | Lewalter T, Weiss C, Spencker S, Jung W, Haverkamp W, Willems S, Deneke T, Kautzner J, Wiedemann M, Siebels J, Pitschner HF, Hoffmann E, Hindricks G, Zabel M, Vester E, Schwacke H, Mittmann-Braun E, Lickfett L, Hoffmeister S, Proff J, Mewis C, Bauer W; AURUM 8 Study Investigators. Gold vs. platinum-iridium tip catheter for cavotricuspid isthmus ablation: the AURUM 8 study. Europace. 2011 Jan;13(1):102-8. doi: 10.1093/europace/euq339. Epub 2010 Sep 28. |
| 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 |
|---|---|
| D017548 | Echocardiography, Transesophageal |
| ID | Term |
|---|---|
| D004452 | Echocardiography |
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
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