Diagnostic Utility of Cardiac MRI

NCT07679009 | Enrolling By Invitation FDA Device

• 1 other identifier: 024-421
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective cohort study looking to systematically evaluate the safety of conducting cardiac Magnetic Resonance Imaging (MRI) in this high-risk patient group with abandoned, fractured endocardial leads or surgically implanted permanent epicardial leads, by monitoring clinical outcome and device functionality (if active device present).

Conditions

Abandoned Endocardial Leads; Broken Endocardial Leads; Permanent Epicardial Leads

Keywords

Cardiac Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Evaluating the safety of CMR

  To systematically evaluate the safety of conducting cardiac Magnetic Resonance Imaging (MRI) in this high-risk patient group with abandoned, fractured endocardial leads or surgically implanted permanent epicardial leads, by monitoring clinical outcome and device functionality (if active device present). This is done by evaluating and reviewing the CMR images.

  6 months

Secondary Outcomes (2)

• Diagnostic Value of CMR

  6 months

• Protocol Development.

  2 years.

Study Arms (1)

abandoned or broken endocardial leads and surgically placed permanent epicardial leads

OTHER

Device: Cardiac MRI (CMR)

Interventions

Cardiac MRI (CMR) DEVICE

Conducting cardiac MRI in a high-risk patient group with abandoned, fractured endocardial leads or surgically implanted permanent epicardial leads, by monitoring clinical outcome and device functionality (if active device present) to determine the diagnostic value of Cardiac MRI in these patients.

abandoned or broken endocardial leads and surgically placed permanent epicardial leads

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals 18 years and older
• Individuals with abandoned, fractured endocardial
• Individuals with permanent epicardial pacemaker or implantable cardioverter-defibrillator (ICD) leads

You may not qualify if:

• Within 6 weeks post device implantation, unless more urgent clinical needs dictate an earlier scan;
• Pregnant individuals
• Individuals with severe claustrophobia
• Individuals with other known contraindications for MRI, as determined by study doctor

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Scott and White Vascular Hospital

Dallas, Texas, 75226, United States

Location

Related Publications (11)

• Langman DA, Finn JP, Ennis DB. Abandoned pacemaker leads are a potential risk for patients undergoing MRI. Pacing Clin Electrophysiol. 2011 Sep;34(9):1051-3. doi: 10.1111/j.1540-8159.2011.03176.x. Epub 2011 Jul 28. No abstract available.

  PMID: 21797902 BACKGROUND

• Russo RJ, Costa HS, Silva PD, Anderson JL, Arshad A, Biederman RW, Boyle NG, Frabizzio JV, Birgersdotter-Green U, Higgins SL, Lampert R, Machado CE, Martin ET, Rivard AL, Rubenstein JC, Schaerf RH, Schwartz JD, Shah DJ, Tomassoni GF, Tominaga GT, Tonkin AE, Uretsky S, Wolff SD. Assessing the Risks Associated with MRI in Patients with a Pacemaker or Defibrillator. N Engl J Med. 2017 Feb 23;376(8):755-764. doi: 10.1056/NEJMoa1603265.

  PMID: 28225684 BACKGROUND

• Indik JH, Gimbel JR, Abe H, Alkmim-Teixeira R, Birgersdotter-Green U, Clarke GD, Dickfeld TL, Froelich JW, Grant J, Hayes DL, Heidbuchel H, Idriss SF, Kanal E, Lampert R, Machado CE, Mandrola JM, Nazarian S, Patton KK, Rozner MA, Russo RJ, Shen WK, Shinbane JS, Teo WS, Uribe W, Verma A, Wilkoff BL, Woodard PK. 2017 HRS expert consensus statement on magnetic resonance imaging and radiation exposure in patients with cardiovascular implantable electronic devices. Heart Rhythm. 2017 Jul;14(7):e97-e153. doi: 10.1016/j.hrthm.2017.04.025. Epub 2017 May 11. No abstract available.

  PMID: 28502708 BACKGROUND

• Balmer C, Gass M, Dave H, Duru F, Luechinger R. Magnetic resonance imaging of patients with epicardial leads: in vitro evaluation of temperature changes at the lead tip. J Interv Card Electrophysiol. 2019 Dec;56(3):321-326. doi: 10.1007/s10840-019-00627-7. Epub 2019 Nov 12.

  PMID: 31713219 BACKGROUND

• Vuorinen AM, Pakarinen S, Jaakkola I, Holmstrom M, Kivisto S, Kaasalainen T. Clinical experience of magnetic resonance imaging in patients with cardiac pacing devices: unrestricted patient population. Acta Radiol. 2019 Nov;60(11):1414-1421. doi: 10.1177/0284185119830288. Epub 2019 Feb 19.

  PMID: 30781967 BACKGROUND

• Padmanabhan D, Kella DK, Mehta R, Kapa S, Deshmukh A, Mulpuru S, Jaffe AS, Felmlee JP, Jondal ML, Dalzell CM, Asirvatham SJ, Cha YM, Watson RE Jr, Friedman PA. Safety of magnetic resonance imaging in patients with legacy pacemakers and defibrillators and abandoned leads. Heart Rhythm. 2018 Feb;15(2):228-233. doi: 10.1016/j.hrthm.2017.10.022. Epub 2017 Oct 16.

  PMID: 29045806 BACKGROUND

• Gakenheimer-Smith L, Etheridge SP, Niu MC, Ou Z, Presson AP, Whitaker P, Su J, Puchalski MD, Asaki SY, Pilcher T. MRI in pediatric and congenital heart disease patients with CIEDs and epicardial or abandoned leads. Pacing Clin Electrophysiol. 2020 Aug;43(8):797-804. doi: 10.1111/pace.13984. Epub 2020 Jul 6.

  PMID: 32533566 BACKGROUND

• Schaller RD, Brunker T, Riley MP, Marchlinski FE, Nazarian S, Litt H. Magnetic Resonance Imaging in Patients With Cardiac Implantable Electronic Devices With Abandoned Leads. JAMA Cardiol. 2021 May 1;6(5):549-556. doi: 10.1001/jamacardio.2020.7572.

  PMID: 33595595 BACKGROUND

• Kim D, Collins JD, White JA, Hanneman K, Lee DC, Patel AR, Hu P, Litt H, Weinsaft JW, Davids R, Mukai K, Ng MY, Luetkens JA, Roguin A, Rochitte CE, Woodard PK, Manisty C, Zareba KM, Mont L, Bogun F, Ennis DB, Nazarian S, Webster G, Stojanovska J. SCMR expert consensus statement for cardiovascular magnetic resonance of patients with a cardiac implantable electronic device. J Cardiovasc Magn Reson. 2024 Summer;26(1):100995. doi: 10.1016/j.jocmr.2024.100995. Epub 2024 Jan 12.

  PMID: 38219955 BACKGROUND

• Habash F, Wang H, Assar M. Assessment of Safety and Time Utilization of Remote Device Interrogation in Patients with Conditional and Non-conditional Cardiac Implantable Electronic Devices Undergoing MRI. Heart Rhythm, Vol 20, No 5S, May Supplement 2023

  BACKGROUND

• Sovic W, Habash F, Doss R, Shaar M, Wang H, Assar M. Safety of MRI in Patients with Non-Conditional Cardiovascular Implantable Electronic Devices Due to Legacy Components or Generator and Lead Manufacturer Mismatch. Selected to be orally presented at HRS 2024 meeting.

  BACKGROUND

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 1, 2026
• Study Start: January 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)