MRI Assessment of Arrythmia Ablation Lesions
17 janvier 2020 mis à jour par: Charles Berul, Children's National Research Institute
This study will evaluate the feasibility of visualization and characterization of arrhythmia ablation lesions by MRI immediately following standard ablation techniques.
The appearance of the ablation lesion will be correlated with clinical outcomes and risk of arrhythmia recurrence.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
Children's National Heart Institute (CNHI) with major contractual support from the National Institutes of Health / National Heart, Lung and Blood Institute has installed a combined X-ray / Magnetic Resonance Imaging cardiac catheterization lab suite allowing for experts in the fields of cardiac MRI, interventional cardiac MRI and clinical pediatric interventional electrophysiology to work together to make substantial advancements in the development of novel techniques and applications to reach the goal of improved survival and care for the congenital heart disease population.
The CNHI X-ray/MRI suite will allow for streamlined transfer of patients from fluoroscopy directly to the MRI scanner under the same sedation thereby allowing for immediate post procedure imaging and minimizing risk to the patient.
Type d'étude
Interventionnel
Inscription (Réel)
16
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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District of Columbia
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Washington, District of Columbia, États-Unis, 20010
- Children's National Health System
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Written informed consent from any patient willing to participate who is undergoing an electrophysiology study with potential for arrhythmia ablation
- Written informed assent, if applicable
Exclusion Criteria:
- Women who are pregnant
- Women who are nursing and who do not plan to discard breast milk for 24 hours
Patients with a contraindication to MRI scanning will be excluded. These contraindications include patients with the following devices:
- Central nervous system aneurysm clips
- Implanted neural stimulator
- Implanted cardiac pacemaker or defibrillator which are not MR safe or MR conditional according to the manufacturer
- Cochlear implant
- Ocular foreign body (e.g. metal shavings)
- Implanted Insulin pump
- Metal shrapnel or bullet.
- Any intracardiac or intravascular device that is not MR safe or MR conditional according to the manufacturer based on both material and timing of device placement
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Autre: MRI scan
Post ablation MRI scan will be performed for all subjects who are clinically stable.
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Following the clinically indicated cardiac ablation procedure, a post ablation MRI scan will be performed.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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The number of participants following ablation procedure who: a). have an arrythmia reoccurrence, b). require a repeat ablation procedure, and c). require treatment for arrhythmia management
Délai: Post ablation up to 5 years
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Post ablation up to 5 years
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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To measure the size of the ablation lesion on cardiac MR imaging
Délai: At the end of each ablation procedure through study completion, up to 5 years.
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At the end of each ablation procedure through study completion, up to 5 years.
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The number of post ablation MR images with a visible lesion.
Délai: At the end of each ablation procedure through study completion, up to 5 years.
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At the end of each ablation procedure through study completion, up to 5 years.
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Charles Berul, MD, Children's National Research Institute
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
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- Ratnayaka K, Faranesh AZ, Hansen MS, Stine AM, Halabi M, Barbash IM, Schenke WH, Wright VJ, Grant LP, Kellman P, Kocaturk O, Lederman RJ. Real-time MRI-guided right heart catheterization in adults using passive catheters. Eur Heart J. 2013 Feb;34(5):380-9. doi: 10.1093/eurheartj/ehs189. Epub 2012 Aug 1.
- Razavi R, Hill DL, Keevil SF, Miquel ME, Muthurangu V, Hegde S, Rhode K, Barnett M, van Vaals J, Hawkes DJ, Baker E. Cardiac catheterisation guided by MRI in children and adults with congenital heart disease. Lancet. 2003 Dec 6;362(9399):1877-82. doi: 10.1016/S0140-6736(03)14956-2.
- Nazarian S, Kolandaivelu A, Zviman MM, Meininger GR, Kato R, Susil RC, Roguin A, Dickfeld TL, Ashikaga H, Calkins H, Berger RD, Bluemke DA, Lardo AC, Halperin HR. Feasibility of real-time magnetic resonance imaging for catheter guidance in electrophysiology studies. Circulation. 2008 Jul 15;118(3):223-9. doi: 10.1161/CIRCULATIONAHA.107.742452. Epub 2008 Jun 23.
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- Kettering K, Greil GF, Fenchel M, Kramer U, Weig HJ, Busch M, Miller S, Sieverding L, Laszlo R, Schreieck J. Catheter ablation of atrial fibrillation using the Navx-/Ensite-system and a CT-/MRI-guided approach. Clin Res Cardiol. 2009 May;98(5):285-96. doi: 10.1007/s00392-009-0001-9. Epub 2009 Mar 13.
- Sasaki T, Miller CF, Hansford R, Yang J, Caffo BS, Zviman MM, Henrikson CA, Marine JE, Spragg D, Cheng A, Tandri H, Sinha S, Kolandaivelu A, Zimmerman SL, Bluemke DA, Tomaselli GF, Berger RD, Calkins H, Halperin HR, Nazarian S. Myocardial structural associations with local electrograms: a study of postinfarct ventricular tachycardia pathophysiology and magnetic resonance-based noninvasive mapping. Circ Arrhythm Electrophysiol. 2012 Dec;5(6):1081-90. doi: 10.1161/CIRCEP.112.970699. Epub 2012 Nov 13.
- Godeschalk-Slagboom CJ, van der Geest RJ, Zeppenfeld K, Botha CP. Cardiac MRI visualization for ventricular tachycardia ablation. Int J Comput Assist Radiol Surg. 2012 Sep;7(5):753-67. doi: 10.1007/s11548-012-0776-4. Epub 2012 Jul 3.
- Dickfeld T, Tian J, Ahmad G, Jimenez A, Turgeman A, Kuk R, Peters M, Saliaris A, Saba M, Shorofsky S, Jeudy J. MRI-Guided ventricular tachycardia ablation: integration of late gadolinium-enhanced 3D scar in patients with implantable cardioverter-defibrillators. Circ Arrhythm Electrophysiol. 2011 Apr;4(2):172-84. doi: 10.1161/CIRCEP.110.958744. Epub 2011 Jan 26.
- Yokokawa M, Mueller G, Bogun F. Role of imaging in ablation therapy of ventricular arrhythmias. Focus on cardiac magnetic resonance imaging. Circ J. 2012;76(6):1292-8. doi: 10.1253/circj.cj-12-0544. Epub 2012 May 22.
- Nazarian S, Bluemke DA, Halperin HR. Applications of cardiac magnetic resonance in electrophysiology. Circ Arrhythm Electrophysiol. 2009 Feb;2(1):63-71. doi: 10.1161/CIRCEP.108.811562.
- Mahnkopf C, Halbfass P, Turschner O, Brachmann J. [Use of cardiac MRI in the field of electrophysiology. Present status and future aspects]. Herzschrittmacherther Elektrophysiol. 2012 Dec;23(4):275-80. doi: 10.1007/s00399-012-0238-2. Epub 2012 Nov 7. German.
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- Ranjan R, Kholmovski EG, Blauer J, Vijayakumar S, Volland NA, Salama ME, Parker DL, MacLeod R, Marrouche NF. Identification and acute targeting of gaps in atrial ablation lesion sets using a real-time magnetic resonance imaging system. Circ Arrhythm Electrophysiol. 2012 Dec;5(6):1130-5. doi: 10.1161/CIRCEP.112.973164. Epub 2012 Oct 15.
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Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 avril 2014
Achèvement primaire (Réel)
18 janvier 2020
Achèvement de l'étude (Réel)
18 janvier 2020
Dates d'inscription aux études
Première soumission
25 avril 2016
Première soumission répondant aux critères de contrôle qualité
2 mai 2016
Première publication (Estimation)
4 mai 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
21 janvier 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
17 janvier 2020
Dernière vérification
1 janvier 2020
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 4065
- contract (Autre identifiant: NIH)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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