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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02739087
Other study ID # 3860
Secondary ID Internal Bridge
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 2015
Est. completion date December 2024

Study information

Verified date February 2024
Source Children's National Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Currently catheters used in heart catheterization procedures are guided throughout the heart chambers and blood vessels by pictures taken by x-rays. This technology exposes patients to radiation. With this study protocol the investigators will use MRI technology to take real-time pictures to navigate catheters throughout heart chambers. MRI uses electromagnetic energy; therefore, it does not expose participants to radiation energy.


Description:

Participants undergo general anesthesia, and vascular access is obtained in the x-ray catheterization lab. Next the participant is transferred into the MRI scanner where a focused MRI examination is performed. Catheters are then guided into the heart chambers using real-time MRI guidance to perform conventional cardiac catheterization steps. If time allows, additional research MRI is performed before the participant is returned to the x-ray catheterization lab. If any MRI guided catheterization steps are unsuccessful, the clinically indicated step is performed after the participant returns to the x-ray catheterization lab using conventional x-ray guided pictures.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 50
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Undergoing a medically necessary cardiovascular catheterization Exclusion Criteria: - Cardiovascular instability including hemodynamic instability (such as requiring significant vasoactive infusion support) or mechanical hemodynamic support. - 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: 1. Central nervous system aneurysm clips 2. Implanted neural stimulator 3. Implanted cardiac pacemaker or defibrillator which are not MR safe or MR conditional according to the manufacturer 4. Cochlear implant 5. Ocular foreign body (e.g. metal shavings) 6. Implanted Insulin pump 7. Metal shrapnel or bullet Exclusion criteria for Gadolinium (contrast agent) 1. Renal disease with estimated glomerular filtration rate < 30 ml/min/1.73 m2 body surface area

Study Design


Intervention

Procedure:
MRI guided cardiac catheterization
Magnetic resonance imaging will be used to guide cardiac catheterization procedures whenever possible to avoid or minimize x-ray radiation exposure.
Device:
Magnetic resonance imaging


Locations

Country Name City State
United States Children's National Health System Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Joshua Kanter

Country where clinical trial is conducted

United States, 

References & Publications (63)

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Elagha AA, Kocaturk O, Guttman MA, Ozturk C, Kim AH, Burton GW, Kim JH, Raman VK, Raval AN, Wright VJ, Schenke WH, McVeigh ER, Lederman RJ. Real-time MR imaging-guided laser atrial septal puncture in swine. J Vasc Interv Radiol. 2008 Sep;19(9):1347-53. doi: 10.1016/j.jvir.2008.05.007. Epub 2008 Jul 21. — View Citation

George AK, Derbyshire JA, Saybasili H, Saikus CE, Kocaturk O, Guttman MA, McVeigh ER, Lederman RJ, Faranesh AZ. Visualization of active devices and automatic slice repositioning ("SnapTo") for MRI-guided interventions. Magn Reson Med. 2010 Apr;63(4):1070-9. doi: 10.1002/mrm.22307. — View Citation

Guttman MA, Dick AJ, Raman VK, Arai AE, Lederman RJ, McVeigh ER. Imaging of myocardial infarction for diagnosis and intervention using real-time interactive MRI without ECG-gating or breath-holding. Magn Reson Med. 2004 Aug;52(2):354-61. doi: 10.1002/mrm.20174. — View Citation

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Guttman MA, Ozturk C, Raval AN, Raman VK, Dick AJ, DeSilva R, Karmarkar P, Lederman RJ, McVeigh ER. Interventional cardiovascular procedures guided by real-time MR imaging: an interactive interface using multiple slices, adaptive projection modes and live 3D renderings. J Magn Reson Imaging. 2007 Dec;26(6):1429-35. doi: 10.1002/jmri.21199. — View Citation

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Kocaturk O, Kim AH, Saikus CE, Guttman MA, Faranesh AZ, Ozturk C, Lederman RJ. Active two-channel 0.035'' guidewire for interventional cardiovascular MRI. J Magn Reson Imaging. 2009 Aug;30(2):461-5. doi: 10.1002/jmri.21844. — View Citation

Kocaturk O, Saikus CE, Guttman MA, Faranesh AZ, Ratnayaka K, Ozturk C, McVeigh ER, Lederman RJ. Whole shaft visibility and mechanical performance for active MR catheters using copper-nitinol braided polymer tubes. J Cardiovasc Magn Reson. 2009 Aug 12;11(1):29. doi: 10.1186/1532-429X-11-29. — View Citation

Krueger JJ, Ewert P, Yilmaz S, Gelernter D, Peters B, Pietzner K, Bornstedt A, Schnackenburg B, Abdul-Khaliq H, Fleck E, Nagel E, Berger F, Kuehne T. Magnetic resonance imaging-guided balloon angioplasty of coarctation of the aorta: a pilot study. Circulation. 2006 Feb 28;113(8):1093-100. doi: 10.1161/CIRCULATIONAHA.105.578112. Epub 2006 Feb 20. — View Citation

Kuehne T, Yilmaz S, Schulze-Neick I, Wellnhofer E, Ewert P, Nagel E, Lange P. Magnetic resonance imaging guided catheterisation for assessment of pulmonary vascular resistance: in vivo validation and clinical application in patients with pulmonary hypertension. Heart. 2005 Aug;91(8):1064-9. doi: 10.1136/hrt.2004.038265. — View Citation

Kuehne T, Yilmaz S, Steendijk P, Moore P, Groenink M, Saaed M, Weber O, Higgins CB, Ewert P, Fleck E, Nagel E, Schulze-Neick I, Lange P. Magnetic resonance imaging analysis of right ventricular pressure-volume loops: in vivo validation and clinical application in patients with pulmonary hypertension. Circulation. 2004 Oct 5;110(14):2010-6. doi: 10.1161/01.CIR.0000143138.02493.DD. Epub 2004 Sep 27. — View Citation

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Lederman RJ, Guttman MA, Peters DC, Thompson RB, Sorger JM, Dick AJ, Raman VK, McVeigh ER. Catheter-based endomyocardial injection with real-time magnetic resonance imaging. Circulation. 2002 Mar 19;105(11):1282-4. doi: 10.1161/01.cir.0000012425.71261.fc. — View Citation

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Miquel ME, Hegde S, Muthurangu V, Corcoran BJ, Keevil SF, Hill DL, Razavi RS. Visualization and tracking of an inflatable balloon catheter using SSFP in a flow phantom and in the heart and great vessels of patients. Magn Reson Med. 2004 May;51(5):988-95. doi: 10.1002/mrm.20041. — View Citation

Muthurangu V, Atkinson D, Sermesant M, Miquel ME, Hegde S, Johnson R, Andriantsimiavona R, Taylor AM, Baker E, Tulloh R, Hill D, Razavi RS. Measurement of total pulmonary arterial compliance using invasive pressure monitoring and MR flow quantification during MR-guided cardiac catheterization. Am J Physiol Heart Circ Physiol. 2005 Sep;289(3):H1301-6. doi: 10.1152/ajpheart.00957.2004. Epub 2005 May 6. — View Citation

Muthurangu V, Taylor A, Andriantsimiavona R, Hegde S, Miquel ME, Tulloh R, Baker E, Hill DL, Razavi RS. Novel method of quantifying pulmonary vascular resistance by use of simultaneous invasive pressure monitoring and phase-contrast magnetic resonance flow. Circulation. 2004 Aug 17;110(7):826-34. doi: 10.1161/01.CIR.0000138741.72946.84. Epub 2004 Aug 9. — View Citation

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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. — View Citation

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Raman VK, Karmarkar PV, Guttman MA, Dick AJ, Peters DC, Ozturk C, Pessanha BS, Thompson RB, Raval AN, DeSilva R, Aviles RJ, Atalar E, McVeigh ER, Lederman RJ. Real-time magnetic resonance-guided endovascular repair of experimental abdominal aortic aneurysm in swine. J Am Coll Cardiol. 2005 Jun 21;45(12):2069-77. doi: 10.1016/j.jacc.2005.03.029. — View Citation

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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. — View Citation

Raval AN, Karmarkar PV, Guttman MA, Ozturk C, Desilva R, Aviles RJ, Wright VJ, Schenke WH, Atalar E, McVeigh ER, Lederman RJ. Real-time MRI guided atrial septal puncture and balloon septostomy in swine. Catheter Cardiovasc Interv. 2006 Apr;67(4):637-43. doi: 10.1002/ccd.20579. — View Citation

Raval AN, Karmarkar PV, Guttman MA, Ozturk C, Sampath S, DeSilva R, Aviles RJ, Xu M, Wright VJ, Schenke WH, Kocaturk O, Dick AJ, Raman VK, Atalar E, McVeigh ER, Lederman RJ. Real-time magnetic resonance imaging-guided endovascular recanalization of chronic total arterial occlusion in a swine model. Circulation. 2006 Feb 28;113(8):1101-7. doi: 10.1161/CIRCULATIONAHA.105.586727. Epub 2006 Feb 20. — View Citation

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* Note: There are 63 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Test the feasibility of navigating catheters into right heart structures using real-time MRI Heart catheterization usually uses X-ray guidance. Using commercially available MRI-compatible catheters, the right heart catheterization procedure will be done using real-time magnetic resonance imaging (MRI). MRI guidance does not use X-ray radiation. At the end of each catheterization procedure through study completion,up to 5 years.
Secondary Number of participants whose MRI cardiac catheterization procedure was prematurely terminated Premature termination will occur under the following circumstances:
Hemodynamic or other clinical instability
Technical failure of catheter procedure such as being unable to navigate the catheters to the heart chamber
Equipment malfunction
Any other circumstance that in the opinion of the Principal Investigator poses hazard to the research subject
At the end of each catheterization procedure through study completion,up to 5 years
Secondary Measurement of radiation exposure Comparison of radiation exposure in this cohort of subjects to historical controls undergoing matched invasive cardiology procedure at CNMC. End of study, 5 years.
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