Abandoned Endocardial LeadsNCT07679009
Diagnostic Utility of Cardiac MRI
A study testing Cardiac MRI (CMR) in people with Abandoned Endocardial Leads and Broken Endocardial Leads, run by Baylor Research Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abandoned Endocardial Leads, Broken Endocardial Leads, Permanent Epicardial Leads
- What is being tested?
- Cardiac MRI (CMR)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals 18 years and older
- Individuals with abandoned, fractured endocardial
- Individuals with permanent epicardial pacemaker or implantable cardioverter-defibrillator (ICD) leads
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Baylor Scott and White Vascular Hospital
Dallas, Texas, 75226
About this study
Official title: Evaluating the Safety and Diagnostic Utility of Cardiac MRI in Patients With Abandoned, Fractured Endocardial Leads or Permanent Epicardial Leads
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).
Read the detailed description
This is a prospective cohort study involving patients with abandoned, fractured endocardial leads, or surgically placed permanent epicardial leads with or without concurrent active cardiac implantable electronic devices (CIEDs), who need cardiac MRI for clinical indications. Participants will undergo a thorough pre-scan evaluation, including chest x-ray (CXR), device interrogation, lead integrity check, and risk assessment. The MRI will be performed using a standardized protocol designed to minimize risks, with continuous patient monitoring during the procedure. Post-scan device interrogation and patient evaluation will assess any immediate and delayed adverse effects.
This study is a descriptive case series, and no statistical comparisons with controls will be made. Descriptive statistics of continuous patient and CIED variables are expressed as the mean+/- SDs (standard deviations), or as medians with interquartile ranges (IOR). Categorical variables are expressed as numbers and percentages.
- Being tested
- Cardiac MRI (CMR)
- Keywords
- Cardiac Magnetic Resonance Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| abandoned or broken endocardial leads and surgically placed permanent epicardial leads | Other | Not described Receives: Device: Cardiac MRI (CMR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
Diagnostic Value of CMR
To determine the diagnostic value of cardiac MRI in these patients, including the quality of imaging and the ability to address clinical questions. This is done by evaluating and reviewing the CMR images.
Measured: 6 months
Protocol Development.
To develop and refine cardiac MRI protocols that effectively minimize risks while maintaining diagnostic quality in this patient group. This is done by taking the results of the CMR imaging and data collected and implementing changes to future protocol to minimize risks.
Measured: 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Jan 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Abandoned Endocardial LeadsStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679009
- Sponsor's protocol ID
- 024-421
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 21797902Russo 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.
PubMed 28225684Indik 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.
PubMed 28502708Balmer 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.
PubMed 31713219Vuorinen 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.
PubMed 30781967Padmanabhan 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.
PubMed 29045806Gakenheimer-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.
PubMed 32533566Schaller 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.
PubMed 33595595Kim 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.
PubMed 38219955Habash 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
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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Safety and Diagnostic Utility of Cardiac MRI in Patients With Abandoned, Fractured Endocardial Leads or Permanent Epicardial Leads
- ClinicalTrials.gov ID
- NCT07679009
- Acronym / sponsor ID
- 024-421
- Keywords
- Cardiac Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This is a prospective cohort study involving patients with abandoned, fractured endocardial leads, or surgically placed permanent epicardial leads with or without concurrent active cardiac implantable electronic devices (CIEDs), who need cardiac MRI for clinical indications. Participants will undergo a thorough pre-scan evaluation, including chest x-ray (CXR), device interrogation, lead integrity check, and risk assessment. The MRI will be performed using a standardized protocol designed to minimize risks, with continuous patient monitoring during the procedure. Post-scan device interrogation and patient evaluation will assess any immediate and delayed adverse effects.
This study is a descriptive case series, and no statistical comparisons with controls will be made. Descriptive statistics of continuous patient and CIED variables are expressed as the mean+/- SDs (standard deviations), or as medians with interquartile ranges (IOR). Categorical variables are expressed as numbers and percentages.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| abandoned or broken endocardial leads and surgically placed permanent epicardial leads | Other | Device: Cardiac MRI (CMR) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals 18 years and older
- Individuals with abandoned, fractured endocardial
- Individuals with permanent epicardial pacemaker or implantable cardioverter-defibrillator (ICD) leads
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac MRI (CMR)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. | Device | abandoned or broken endocardial leads and surgically placed permanent epicardial leads |
Primary outcome
Evaluating the safety of CMR
Time frame: 6 months
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.
2 secondary outcomes
Diagnostic Value of CMR
Time frame: 6 months
Protocol Development.
Time frame: 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Background: PubMed 21797902Langman 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.
- Background: PubMed 28225684Russo 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.
- Background: PubMed 28502708Indik 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.
- Background: PubMed 31713219Balmer 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.
- Background: PubMed 30781967Vuorinen 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.
- Background: PubMed 29045806Padmanabhan 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.
- Background: PubMed 32533566Gakenheimer-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.
- Background: PubMed 33595595Schaller 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.
- Background: PubMed 38219955Kim 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.
- BackgroundHabash 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
- BackgroundSovic 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac MRI (CMR) in people with Abandoned Endocardial Leads and Broken Endocardial Leads, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating the safety of CMR (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07679009, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.