- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02761343
MRI Assessment of Arrythmia Ablation Lesions
17 gennaio 2020 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Effettivo)
16
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
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District of Columbia
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Washington, District of Columbia, Stati Uniti, 20010
- Children's National Health System
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Altro: 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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
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
Lasso di tempo: Post ablation up to 5 years
|
Post ablation up to 5 years
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
To measure the size of the ablation lesion on cardiac MR imaging
Lasso di tempo: 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.
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Investigatori
- Investigatore principale: Charles Berul, MD, Children's National Research Institute
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
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- 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.
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- 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.
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- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 aprile 2014
Completamento primario (Effettivo)
18 gennaio 2020
Completamento dello studio (Effettivo)
18 gennaio 2020
Date di iscrizione allo studio
Primo inviato
25 aprile 2016
Primo inviato che soddisfa i criteri di controllo qualità
2 maggio 2016
Primo Inserito (Stima)
4 maggio 2016
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
21 gennaio 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
17 gennaio 2020
Ultimo verificato
1 gennaio 2020
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 4065
- contract (Altro identificatore: NIH)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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