Reduction of AF Ablation Induced Thrombo-Embolic Incidence Pilot Study
NCT ID: NCT02275260
Last Updated: 2019-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
110 participants
INTERVENTIONAL
2014-12-31
2018-02-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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All patients
All patients undergo cerebral Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI), Transesophageal (or Intracardial) Echocardiography and paperbased neurocognitive testing
Cerebral Diffusion-Weighted Magnetic Resonance Imaging
Patients undergo a cerebral Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI)
Transesophageal Echocardiography
Patients undergo a Transesophageal Echocardiography prior to the ablation itself
Paperbased neurocognitive testing
To assess the impact of PVI on the patient's neurocognitive status
Interventions
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Cerebral Diffusion-Weighted Magnetic Resonance Imaging
Patients undergo a cerebral Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI)
Transesophageal Echocardiography
Patients undergo a Transesophageal Echocardiography prior to the ablation itself
Paperbased neurocognitive testing
To assess the impact of PVI on the patient's neurocognitive status
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with indication for left atrial ablation of AF according to ESC guidelines for the management of atrial fibrillation.
* Anticoagulation according to clinical routine using coumarin derivates with target INR between 2.0 and 3.0 at least 3 weeks prior to the scheduled ablation procedure or novel oral anticoagulants (NOACs).
* Geographically stable for the duration of the study.
* Willingness and ability to perform written informed consent
Exclusion Criteria
* CHA2DS2-VASc score ≥ 5
* Prior ischemic stroke or Transient Ischemic Attack
* Previous Pulmonary Vein ablation
* Contraindication for anticoagulation therapy
* Contraindication for Diffusion-Weighted MRI
* Claustrophobia
* Contraindication for transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE, if TEE not possible)
* Implanted cardiovascular device, including but not limited to an atrial or ventricular pacemaker or defibrillator leads, artificial valves, stents, septal or LAA occluders
* Acute coronary syndrome \< 3 months prior to scheduled ablation
* Moderate to severe valvular heart disease
* LA size \> 55 mm (confirming echo at maximum 3 months old)
* Patients with non-controlled heart failure or patients with current and recent (\< 1 month prior to ablation) heart failure
* Ejection fraction \< 35% (confirming echo at maximum 3 months old)
* Conditions that prevent patient's participation in neurocognitive assessment (at physician's discretion)
* Female patients who are pregnant or breast feeding or plan a pregnancy during the course of the study
* Any limitation to contractual capability
* Simultaneous participation in another study
* Age \< 18 years
18 Years
ALL
No
Sponsors
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University Hospital Heidelberg
OTHER
Biotronik SE & Co. KG
INDUSTRY
Responsible Party
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Principal Investigators
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Dipen Shah, Prof. Dr.
Role: STUDY_CHAIR
Hôpitaux Universitaires de Genève, Switzerland
Boris Schmidt, PD Dr.
Role: STUDY_CHAIR
Cardioangiologisches Centrum Bethanien, Germany
Locations
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Ceske Budejovice Hospital
České Budějovice, , Czechia
Institute for Clinical and Experimental Medicine (IKEM)
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
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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EP025
Identifier Type: -
Identifier Source: org_study_id
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