- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02761343
MRI Assessment of Arrythmia Ablation Lesions
17. Januar 2020 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
16
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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District of Columbia
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Washington, District of Columbia, Vereinigte Staaten, 20010
- Children's National Health System
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Diagnose
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Sonstiges: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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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
Zeitfenster: Post ablation up to 5 years
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Post ablation up to 5 years
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
To measure the size of the ablation lesion on cardiac MR imaging
Zeitfenster: 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.
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Mitarbeiter
Ermittler
- Hauptermittler: Charles Berul, MD, Children's National Research Institute
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
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- 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.
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- 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.
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Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. April 2014
Primärer Abschluss (Tatsächlich)
18. Januar 2020
Studienabschluss (Tatsächlich)
18. Januar 2020
Studienanmeldedaten
Zuerst eingereicht
25. April 2016
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
2. Mai 2016
Zuerst gepostet (Schätzen)
4. Mai 2016
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
21. Januar 2020
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
17. Januar 2020
Zuletzt verifiziert
1. Januar 2020
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 4065
- contract (Andere Kennung: NIH)
Plan für individuelle Teilnehmerdaten (IPD)
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