MRI Assessment of Arrythmia Ablation Lesions
17 de enero de 2020 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
16
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
District of Columbia
-
Washington, District of Columbia, Estados Unidos, 20010
- Children's National Health System
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: MRI scan
Post ablation MRI scan will be performed for all subjects who are clinically stable.
|
Following the clinically indicated cardiac ablation procedure, a post ablation MRI scan will be performed.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
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
Periodo de tiempo: Post ablation up to 5 years
|
Post ablation up to 5 years
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
To measure the size of the ablation lesion on cardiac MR imaging
Periodo de tiempo: At the end of each ablation procedure through study completion, up to 5 years.
|
At the end of each ablation procedure through study completion, up to 5 years.
|
|
The number of post ablation MR images with a visible lesion.
Periodo de tiempo: At the end of each ablation procedure through study completion, up to 5 years.
|
At the end of each ablation procedure through study completion, up to 5 years.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Charles Berul, MD, Children's National Research Institute
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Dillman JR, Ellis JH, Cohan RH, Strouse PJ, Jan SC. Frequency and severity of acute allergic-like reactions to gadolinium-containing i.v. contrast media in children and adults. AJR Am J Roentgenol. 2007 Dec;189(6):1533-8. doi: 10.2214/AJR.07.2554.
- Kleinerman RA. Cancer risks following diagnostic and therapeutic radiation exposure in children. Pediatr Radiol. 2006 Sep;36 Suppl 2(Suppl 2):121-5. doi: 10.1007/s00247-006-0191-5.
- Andreassi MG, Ait-Ali L, Botto N, Manfredi S, Mottola G, Picano E. Cardiac catheterization and long-term chromosomal damage in children with congenital heart disease. Eur Heart J. 2006 Nov;27(22):2703-8. doi: 10.1093/eurheartj/ehl014. Epub 2006 May 22.
- Beels L, Bacher K, De Wolf D, Werbrouck J, Thierens H. gamma-H2AX foci as a biomarker for patient X-ray exposure in pediatric cardiac catheterization: are we underestimating radiation risks? Circulation. 2009 Nov 10;120(19):1903-9. doi: 10.1161/CIRCULATIONAHA.109.880385. Epub 2009 Oct 26.
- Kiringoda R, Thurm AE, Hirschtritt ME, Koziol D, Wesley R, Swedo SE, O'Grady NP, Quezado ZM. Risks of propofol sedation/anesthesia for imaging studies in pediatric research: eight years of experience in a clinical research center. Arch Pediatr Adolesc Med. 2010 Jun;164(6):554-60. doi: 10.1001/archpediatrics.2010.75.
- Haustein J, Laniado M, Niendorf HP, Louton T, Beck W, Planitzer J, Schoffel M, Reiser M, Kaiser W, Schorner W, et al. Triple-dose versus standard-dose gadopentetate dimeglumine: a randomized study in 199 patients. Radiology. 1993 Mar;186(3):855-60. doi: 10.1148/radiology.186.3.8430199.
- Niendorf HP, Alhassan A, Geens VR, Clauss W. Safety review of gadopentetate dimeglumine. Extended clinical experience after more than five million applications. Invest Radiol. 1994 Jun;29 Suppl 2:S179-82. doi: 10.1097/00004424-199406001-00059. No abstract available.
- Niendorf HP, Dinger JC, Haustein J, Cornelius I, Alhassan A, Clauss W. Tolerance data of Gd-DTPA: a review. Eur J Radiol. 1991 Jul-Aug;13(1):15-20. doi: 10.1016/0720-048x(91)90049-2.
- Niendorf HP, Haustein J, Cornelius I, Alhassan A, Clauss W. Safety of gadolinium-DTPA: extended clinical experience. Magn Reson Med. 1991 Dec;22(2):222-8; discussion 229-32. doi: 10.1002/mrm.1910220212.
- Niendorf HP, Haustein J, Louton T, Beck W, Laniado M. Safety and tolerance after intravenous administration of 0.3 mmol/kg Gd-DTPA. Results of a randomized, controlled clinical trial. Invest Radiol. 1991 Nov;26 Suppl 1:S221-3; discussion S232-5. doi: 10.1097/00004424-199111001-00075. No abstract available.
- Sundgren PC, Leander P. Is administration of gadolinium-based contrast media to pregnant women and small children justified? J Magn Reson Imaging. 2011 Oct;34(4):750-7. doi: 10.1002/jmri.22413.
- Deo A, Fogel M, Cowper SE. Nephrogenic systemic fibrosis: a population study examining the relationship of disease development to gadolinium exposure. Clin J Am Soc Nephrol. 2007 Mar;2(2):264-7. doi: 10.2215/CJN.03921106. Epub 2007 Feb 7.
- Mondesert B, Abadir S, Khairy P. Arrhythmias in adult congenital heart disease: the year in review. Curr Opin Cardiol. 2013 May;28(3):354-9. doi: 10.1097/HCO.0b013e32835fb7c2.
- Yap SC, Harris L, Silversides CK, Downar E, Chauhan VS. Outcome of intra-atrial re-entrant tachycardia catheter ablation in adults with congenital heart disease: negative impact of age and complex atrial surgery. J Am Coll Cardiol. 2010 Nov 2;56(19):1589-96. doi: 10.1016/j.jacc.2010.04.061.
- Melby SJ, Lee AM, Zierer A, Kaiser SP, Livhits MJ, Boineau JP, Schuessler RB, Damiano RJ Jr. Atrial fibrillation propagates through gaps in ablation lines: implications for ablative treatment of atrial fibrillation. Heart Rhythm. 2008 Sep;5(9):1296-301. doi: 10.1016/j.hrthm.2008.06.009. Epub 2008 Jun 10.
- Reddy VY, Schmidt EJ, Holmvang G, Fung M. Arrhythmia recurrence after atrial fibrillation ablation: can magnetic resonance imaging identify gaps in atrial ablation lines? J Cardiovasc Electrophysiol. 2008 Apr;19(4):434-7. doi: 10.1111/j.1540-8167.2007.01055.x. Epub 2007 Dec 20.
- 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.
- Faddis MN, Chen J, Osborn J, Talcott M, Cain ME, Lindsay BD. Magnetic guidance system for cardiac electrophysiology: a prospective trial of safety and efficacy in humans. J Am Coll Cardiol. 2003 Dec 3;42(11):1952-8. doi: 10.1016/j.jacc.2003.07.023.
- Ector J, De Buck S, Adams J, Dymarkowski S, Bogaert J, Maes F, Heidbuchel H. Cardiac three-dimensional magnetic resonance imaging and fluoroscopy merging: a new approach for electroanatomic mapping to assist catheter ablation. Circulation. 2005 Dec 13;112(24):3769-76. doi: 10.1161/CIRCULATIONAHA.105.565002. Epub 2005 Dec 5.
- 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.
- Lima JA, Desai MY. Cardiovascular magnetic resonance imaging: current and emerging applications. J Am Coll Cardiol. 2004 Sep 15;44(6):1164-71. doi: 10.1016/j.jacc.2004.06.033.
- Gupta S, Desjardins B, Baman T, Ilg K, Good E, Crawford T, Oral H, Pelosi F, Chugh A, Morady F, Bogun F. Delayed-enhanced MR scar imaging and intraprocedural registration into an electroanatomical mapping system in post-infarction patients. JACC Cardiovasc Imaging. 2012 Feb;5(2):207-10. doi: 10.1016/j.jcmg.2011.08.021.
- Obeyesekere MN. MR scar imaging and intraprocedural registration into an electroanatomic mapping system in post-MI patients. JACC Cardiovasc Imaging. 2012 Aug;5(8):854; author reply 854-5. doi: 10.1016/j.jcmg.2012.05.010. No abstract available.
- Dickfeld T, Kato R, Zviman M, Lai S, Meininger G, Lardo AC, Roguin A, Blumke D, Berger R, Calkins H, Halperin H. Characterization of radiofrequency ablation lesions with gadolinium-enhanced cardiovascular magnetic resonance imaging. J Am Coll Cardiol. 2006 Jan 17;47(2):370-8. doi: 10.1016/j.jacc.2005.07.070.
- Lardo AC, McVeigh ER, Jumrussirikul P, Berger RD, Calkins H, Lima J, Halperin HR. Visualization and temporal/spatial characterization of cardiac radiofrequency ablation lesions using magnetic resonance imaging. Circulation. 2000 Aug 8;102(6):698-705. doi: 10.1161/01.cir.102.6.698.
- 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.
- Ranjan R, Kato R, Zviman MM, Dickfeld TM, Roguin A, Berger RD, Tomaselli GF, Halperin HR. Gaps in the ablation line as a potential cause of recovery from electrical isolation and their visualization using MRI. Circ Arrhythm Electrophysiol. 2011 Jun;4(3):279-86. doi: 10.1161/CIRCEP.110.960567. Epub 2011 Apr 14.
- Ganesan AN, Selvanayagam JB, Mahajan R, Grover S, Nayyar S, Brooks AG, Finnie J, Sunnarborg D, Lloyd T, Chakrabarty A, Abed HS, Sanders P. Mapping and ablation of the pulmonary veins and cavo-tricuspid isthmus with a magnetic resonance imaging-compatible externally irrigated ablation catheter and integrated electrophysiology system. Circ Arrhythm Electrophysiol. 2012 Dec;5(6):1136-42. doi: 10.1161/CIRCEP.112.974436. Epub 2012 Oct 16.
- Vergara GR, Vijayakumar S, Kholmovski EG, Blauer JJ, Guttman MA, Gloschat C, Payne G, Vij K, Akoum NW, Daccarett M, McGann CJ, Macleod RS, Marrouche NF. Real-time magnetic resonance imaging-guided radiofrequency atrial ablation and visualization of lesion formation at 3 Tesla. Heart Rhythm. 2011 Feb;8(2):295-303. doi: 10.1016/j.hrthm.2010.10.032. Epub 2010 Oct 27.
- Nordbeck P, Beer M, Kostler H, Ladd ME, Quick HH, Bauer WR, Ritter O. Cardiac catheter ablation under real-time magnetic resonance guidance. Eur Heart J. 2012 Aug;33(15):1977. doi: 10.1093/eurheartj/ehs139. Epub 2012 Jun 7. No abstract available.
- Ozgun M, Maintz D, Bunck AC, Monnig G, Eckardt L, Wasmer K, Heindel W, Botnar RM, Kirchhof P. Right atrial scar detection after catheter ablation: Comparison of 2D and high spatial resolution 3D-late enhancement magnetic resonance imaging. Acad Radiol. 2011 Apr;18(4):488-94. doi: 10.1016/j.acra.2010.12.004. Epub 2011 Jan 28.
- Arujuna A, Karim R, Caulfield D, Knowles B, Rhode K, Schaeffter T, Kato B, Rinaldi CA, Cooklin M, Razavi R, O'Neill MD, Gill J. Acute pulmonary vein isolation is achieved by a combination of reversible and irreversible atrial injury after catheter ablation: evidence from magnetic resonance imaging. Circ Arrhythm Electrophysiol. 2012 Aug 1;5(4):691-700. doi: 10.1161/CIRCEP.111.966523. Epub 2012 May 31.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de abril de 2014
Finalización primaria (Actual)
18 de enero de 2020
Finalización del estudio (Actual)
18 de enero de 2020
Fechas de registro del estudio
Enviado por primera vez
25 de abril de 2016
Primero enviado que cumplió con los criterios de control de calidad
2 de mayo de 2016
Publicado por primera vez (Estimar)
4 de mayo de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
21 de enero de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
17 de enero de 2020
Última verificación
1 de enero de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 4065
- contract (Otro identificador: NIH)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Taquicardia ventricular
-
University Hospital DubravaDesconocidoDisfunción ventricular derecha | Disfunción Ventricular Izquierda | Insuficiencia biventricularCroacia
-
Jewish General HospitalAún no reclutandoDisfunción ventricular derecha | Disfunción Ventricular Izquierda | Calidad de recuperaciónCanadá
-
University of ChicagoReclutamientoInsuficiencia cardiaca | Disfunción ventricular derecha | Insuficiencia ventricular derechaEstados Unidos
-
University Hospital, MontpellierTerminadoDisfunción ventricular derecha | Arritmia ventricularFrancia
-
Azienda Ospedaliera OO.RR. S. Giovanni di Dio e...ReclutamientoDisfunción ventricular derechaItalia
-
University of GiessenGerman Research FoundationDesconocidoDisfunción ventricular derechaAlemania
-
NHS National Waiting Times Centre BoardNHS Greater Glasgow and Clyde; University of Glasgow; Royal London HospitalAún no reclutandoDisfunción ventricular derechaReino Unido
-
University of MinnesotaReclutamiento
-
Berlin Heart, IncDesconocidoDisfunción ventricular | Disfunción Ventricular Izquierda | Disfunción Ventricular DerechaEstados Unidos
-
Thomas Jefferson UniversityReclutamiento
Ensayos clínicos sobre MRI scan
-
Radboud University Medical CenterTerminadoNeoplasias de Cabeza y CuelloPaíses Bajos
-
Centre Henri BecquerelDesconocidoCarcinoma de células escamosas de orofaringeFrancia
-
Association de Recherche Bibliographique pour les...University of Cambridge; Centre Hospitalier Princesse Grace; Institut National...TerminadoLesiones Cerebrales | Lesiones Deportivas | Conmoción CerebralMónaco
-
Spaulding Rehabilitation HospitalMichael J. Fox Foundation for Parkinson's ResearchTerminado
-
Check-Cap Ltd.TerminadoRiesgo de cáncer colorrectalIsrael
-
Prim. Prof. Dr. Oliver Findl, MBAESCRSDesconocidoCatarata | Miopía | Desprendimiento de retina pseudofáquicoAustria
-
University of NebraskaPostgraduate Institute of Medical Education and Research; Luigi Sacco University...Retirado
-
University Hospital, MontpellierTerminadoPronación-supinación del antebrazo, deterioro deFrancia
-
Check-Cap Ltd.TerminadoCáncer colonrectalIsrael
-
The Netherlands Cancer InstituteTerminado