Safety of MRIMRIMLDNCT07155135

Safety of Magnetic Resonance Imaging With Patients Who Have Mixed Lead Cardiac Implantable Electronic Devices

An observational study of Safety of MRI, run by Socal Heart at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study is looking at the safety and efficacy of using MRIs with patients who have cardiac implantable electronic devices. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Safety of MRI
What is being tested?: MRI
How many people: 16 participants
Where: 1 siteUnited States
Study dates: 1 Jul 2021to 18 Aug 2025
Phase: Observational
Are there results?: None posted in the registry

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

Study population: Average age of patients are 82 years old. All 100% of RA leads and devices were manufactured by Abbott; 31% of RV leads were manufactured by Boston Scientific, with the remaining 69% of RV leads by Medtronic.

Who may be able to join

have a mixed-lead CIED
clinical relevant MRI

Who cannot join

same manufactured CIED

Trial locations and contacts

1 site in 1 country.

United States1 site

Southern California Heart Specialists
Pasadena, California, 91105

Other trials in United States

About this study

Official title: Magnetic Resonance Imaging Safety in Patients With Non-Conditional, Mixed-Manufacturer Cardiac Implantable Electronic Devices

This study is looking at the safety and efficacy of using MRIs with patients who have cardiac implantable electronic devices.

Read the detailed description

Magnetic resonance imaging (MRI) is a critical diagnostic tool known for its non-invasive nature and high-resolution imaging capabilities. However, its safety in patients with cardiac implantable electronic devices (CIEDs), particularly those with mixed-lead systems, remains a significant clinical concern. This report investigates the safety and efficacy of MRI in such patients, where generators and leads originate from different manufacturers and are not officially deemed MRI-conditional.

Conditions: Safety of MRI
Being tested: MRI
Keywords: cardiac implantable electronic devices, CIED, MRI, Magnetic Resonance Imaging, safety

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MRIDiagnostic test
Magnetic resonance imaging (MRI) is a vital diagnostic tool in modern medicine due to its ability to produce detailed images of the body's internal structures without using ionizing radiation.

Study groups in NCT07155135
Study group	Role	What they receive
Patients with mixed-lead Cardiac Implantable Electronic Devices		Patients recieved clinical relevant MRI's. Patients are checked for complications post-MRI. Receives: Diagnostic Test: MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluation of Changes in Device Battery Voltage (Volts)
report Device Battery Voltage (in Volts) prior to the MRI and after the MRI and determine if there was a change in voltage greater than 10% from the initial measurement to the final measurement.
Measured: Immediately Prior to MRI and Immediately after MRI
Evaluation of Changes in Lead Impedance (Ohms)
report lead impedance (in Ohms) prior to the MRI and after the MRI and determine if there is a change in impedence greater than 20% from the initial measurement to the final measurement.
Measured: Immediately Prior to MRI and Immediately after MRI
Evaluation of Changes in Lead Threshold (Voltage) Before and After MRI
report lead threshold in (voltage) prior to MRI and after the MRI and determine if there is a change greater than10% from the initial measurement to the final measurement.
Measured: Immediately Prior to MRI and Immediately after MRI

Secondary outcomes (1)

Evaluation of Changes in Patient Clinical Outcomes (Rhythm, Symptoms, Cardiac Arrest, or Death) Before and After MRI
We will review medical records and determine if there were any observed change in patient rhythm, symptoms (such as chest pain, syncope), cardiac arrest or death after the MRI was completed.
Measured: Immediately Prior to MRI and Immediately after MRI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 202118 Aug 2025

First posted4 Sep 2025
Study start1 Jul 2021
Primary completion18 Aug 2025
Study completion18 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Safety of MRIStudies of the same condition, open and under way.
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: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07155135
Sponsor's protocol ID: 2025818
Acronym: MRIMLD
Status last verified: Aug 2025
First submitted: 19 Aug 2025
Last updated: 4 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: IPD will not be shared due to privacy.

Publications

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.
PubMed 28225684
Nazarian, S., Hansford, R., Rahsepar, A. A., et al. (2021). "MRI for patients with non-MRI-conditional cardiac devices." The New England Journal of Medicine, 384(7), 674-675.
Russo, R. J., Costa, H. S., Silva, P. D., et al. (2017). "Assessing the risks associated with MRI in patients with cardiac devices." Journal of the American College of Cardiology, 69(8), 1123-1133.
Lanz H, Strauss K, Hopler J, Kraft M, Hoffmann S, Binzenhofer L, Gade N, Roden D, Saleh I, Kaab S, Lackermair K, Sadoni S, Hagl C, Massberg S, Estner H, Fichtner S, Lusebrink E. Safety of Magnetic Resonance Imaging in Patients with Cardiac Implantable Electronic Devices. J Cardiovasc Dev Dis. 2024 Oct 8;11(10):313. doi: 10.3390/jcdd11100313.
PubMed 39452284
Nazarian S, Hansford R, Rahsepar AA, Weltin V, McVeigh D, Gucuk Ipek E, Kwan A, Berger RD, Calkins H, Lardo AC, Kraut MA, Kamel IR, Zimmerman SL, Halperin HR. Safety of Magnetic Resonance Imaging in Patients with Cardiac Devices. N Engl J Med. 2017 Dec 28;377(26):2555-2564. doi: 10.1056/NEJMoa1604267.
PubMed 29281579
Mason S, Osborn JS, Dhar R, Tonkin A, Ethington JD, Le V, Benuzillo J, Lappe DL, Knowlton KU, Bunch TJ, Anderson JL. Real world MRI experience with nonconditional and conditional cardiac rhythm devices after MagnaSafe. J Cardiovasc Electrophysiol. 2017 Dec;28(12):1468-1474. doi: 10.1111/jce.13351. Epub 2017 Nov 1.
PubMed 28960745
Martin ET, Sandler DA. MRI in patients with cardiac devices. Curr Cardiol Rep. 2007 Mar;9(1):63-71. doi: 10.1007/s11886-007-0012-y.
PubMed 17362687
Madigan JD, Choudhri AF, Chen J, Spotnitz HM, Oz MC, Edwards N. Surgical management of the patient with an implanted cardiac device: implications of electromagnetic interference. Ann Surg. 1999 Nov;230(5):639-47. doi: 10.1097/00000658-199911000-00005.
PubMed 10561087
Driller J, Barold SS, Parsonnet V. Normal and abnormal function of the pacemaker magnetic reed switch. J Electrocardiol. 1976;9(3):283-92. doi: 10.1016/s0022-0736(76)80058-1.
PubMed 781163
Irnich W, Irnich B, Bartsch C, Stertmann WA, Gufler H, Weiler G. Do we need pacemakers resistant to magnetic resonance imaging? Europace. 2005 Jul;7(4):353-65. doi: 10.1016/j.eupc.2005.02.120.
PubMed 15944094
Luechinger R, Zeijlemaker VA, Pedersen EM, Mortensen P, Falk E, Duru F, Candinas R, Boesiger P. In vivo heating of pacemaker leads during magnetic resonance imaging. Eur Heart J. 2005 Feb;26(4):376-83; discussion 325-7. doi: 10.1093/eurheartj/ehi009. Epub 2004 Nov 29.
PubMed 15618060
Kodali S, Baher A, Shah D. Safety of MRIs in patients with pacemakers and defibrillators. Methodist Debakey Cardiovasc J. 2013 Jul-Sep;9(3):137-41. doi: 10.14797/mdcj-9-3-137.
PubMed 24066196
Luechinger R, Duru F, Scheidegger MB, Boesiger P, Candinas R. Force and torque effects of a 1.5-Tesla MRI scanner on cardiac pacemakers and ICDs. Pacing Clin Electrophysiol. 2001 Feb;24(2):199-205. doi: 10.1046/j.1460-9592.2001.00199.x.
PubMed 11270700
Ferreira AM, Costa F, Tralhao A, Marques H, Cardim N, Adragao P. MRI-conditional pacemakers: current perspectives. Med Devices (Auckl). 2014 May 7;7:115-24. doi: 10.2147/MDER.S44063. eCollection 2014.
PubMed 24851058

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Magnetic Resonance Imaging Safety in Patients With Non-Conditional, Mixed-Manufacturer Cardiac Implantable Electronic Devices
ClinicalTrials.gov ID: NCT07155135
Acronym / sponsor ID: MRIMLD / 2025818
Conditions: Safety of MRI
Keywords: cardiac implantable electronic devices, CIED, MRI, Magnetic Resonance Imaging, safety
Study type: Observational
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Socal HeartIndustry (pharma, biotech, devices)
Study start: 1 Jul 2021 (actual)
Primary completion: 18 Aug 2025 (actual)
Study completion: 18 Aug 2025 (actual)
First posted: 4 Sep 2025 (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 study is looking at the safety and efficacy of using MRIs with patients who have cardiac implantable electronic devices.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Patients with mixed-lead Cardiac Implantable Electronic Devices	–	Diagnostic Test: MRIPatients recieved clinical relevant MRI's. Patients are checked for complications post-MRI.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Average age of patients are 82 years old. All 100% of RA leads and devices were manufactured by Abbott; 31% of RV leads were manufactured by Boston Scientific, with the remaining 69% of RV leads by Medtronic.

Key inclusion criteria (2 listed)

have a mixed-lead CIED
clinical relevant MRI

Key exclusion criteria (1 listed)

same manufactured CIED

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
MRIMagnetic resonance imaging (MRI) is a vital diagnostic tool in modern medicine due to its ability to produce detailed images of the body's internal structures without using ionizing radiation.	Diagnostic test	Patients with mixed-lead Cardiac Implantable Electronic Devices

Primary outcome

Evaluation of Changes in Device Battery Voltage (Volts)
Time frame: Immediately Prior to MRI and Immediately after MRI
report Device Battery Voltage (in Volts) prior to the MRI and after the MRI and determine if there was a change in voltage greater than 10% from the initial measurement to the final measurement.
Evaluation of Changes in Lead Impedance (Ohms)
Time frame: Immediately Prior to MRI and Immediately after MRI
report lead impedance (in Ohms) prior to the MRI and after the MRI and determine if there is a change in impedence greater than 20% from the initial measurement to the final measurement.
Evaluation of Changes in Lead Threshold (Voltage) Before and After MRI
Time frame: Immediately Prior to MRI and Immediately after MRI
report lead threshold in (voltage) prior to MRI and after the MRI and determine if there is a change greater than10% from the initial measurement to the final measurement.

1 secondary outcome

Evaluation of Changes in Patient Clinical Outcomes (Rhythm, Symptoms, Cardiac Arrest, or Death) Before and After MRI
Time frame: Immediately Prior to MRI and Immediately after MRI

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
Results publication: 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.
Results publicationNazarian, S., Hansford, R., Rahsepar, A. A., et al. (2021). "MRI for patients with non-MRI-conditional cardiac devices." The New England Journal of Medicine, 384(7), 674-675.
Results publicationRusso, R. J., Costa, H. S., Silva, P. D., et al. (2017). "Assessing the risks associated with MRI in patients with cardiac devices." Journal of the American College of Cardiology, 69(8), 1123-1133.
Results publication: PubMed 39452284Lanz H, Strauss K, Hopler J, Kraft M, Hoffmann S, Binzenhofer L, Gade N, Roden D, Saleh I, Kaab S, Lackermair K, Sadoni S, Hagl C, Massberg S, Estner H, Fichtner S, Lusebrink E. Safety of Magnetic Resonance Imaging in Patients with Cardiac Implantable Electronic Devices. J Cardiovasc Dev Dis. 2024 Oct 8;11(10):313. doi: 10.3390/jcdd11100313.
Results publication: PubMed 29281579Nazarian S, Hansford R, Rahsepar AA, Weltin V, McVeigh D, Gucuk Ipek E, Kwan A, Berger RD, Calkins H, Lardo AC, Kraut MA, Kamel IR, Zimmerman SL, Halperin HR. Safety of Magnetic Resonance Imaging in Patients with Cardiac Devices. N Engl J Med. 2017 Dec 28;377(26):2555-2564. doi: 10.1056/NEJMoa1604267.
Results publication: PubMed 28960745Mason S, Osborn JS, Dhar R, Tonkin A, Ethington JD, Le V, Benuzillo J, Lappe DL, Knowlton KU, Bunch TJ, Anderson JL. Real world MRI experience with nonconditional and conditional cardiac rhythm devices after MagnaSafe. J Cardiovasc Electrophysiol. 2017 Dec;28(12):1468-1474. doi: 10.1111/jce.13351. Epub 2017 Nov 1.
Results publication: PubMed 17362687Martin ET, Sandler DA. MRI in patients with cardiac devices. Curr Cardiol Rep. 2007 Mar;9(1):63-71. doi: 10.1007/s11886-007-0012-y.
Results publication: PubMed 10561087Madigan JD, Choudhri AF, Chen J, Spotnitz HM, Oz MC, Edwards N. Surgical management of the patient with an implanted cardiac device: implications of electromagnetic interference. Ann Surg. 1999 Nov;230(5):639-47. doi: 10.1097/00000658-199911000-00005.
Results publication: PubMed 781163Driller J, Barold SS, Parsonnet V. Normal and abnormal function of the pacemaker magnetic reed switch. J Electrocardiol. 1976;9(3):283-92. doi: 10.1016/s0022-0736(76)80058-1.
Results publication: PubMed 15944094Irnich W, Irnich B, Bartsch C, Stertmann WA, Gufler H, Weiler G. Do we need pacemakers resistant to magnetic resonance imaging? Europace. 2005 Jul;7(4):353-65. doi: 10.1016/j.eupc.2005.02.120.
Results publication: PubMed 15618060Luechinger R, Zeijlemaker VA, Pedersen EM, Mortensen P, Falk E, Duru F, Candinas R, Boesiger P. In vivo heating of pacemaker leads during magnetic resonance imaging. Eur Heart J. 2005 Feb;26(4):376-83; discussion 325-7. doi: 10.1093/eurheartj/ehi009. Epub 2004 Nov 29.
Results publication: PubMed 24066196Kodali S, Baher A, Shah D. Safety of MRIs in patients with pacemakers and defibrillators. Methodist Debakey Cardiovasc J. 2013 Jul-Sep;9(3):137-41. doi: 10.14797/mdcj-9-3-137.
MagnaSafe Registry. Summary of the MagnaSafe Protocol.Link provided by the sponsor.
Initial data presented on world's first MRI-safe pacemaker. DAIC DiCardiology. 2008 Sep 1 \[cited 2025 Jun 21\]Link provided by the sponsor.
MRI Safety in Patients with Cardiac Implantable Electronic Devices: A Review. Radiology. 2018Link provided by the sponsor.
Individual participant dataSharing planned: No. IPD will not be shared due to privacy.

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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. This study is not recruiting at the moment.

Babak Tashakkor, MD study director

Southern California Heart Specialists

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Safety of MRI, run by Socal Heart 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 4 Sep 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Evaluation of Changes in Device Battery Voltage (Volts) (time frame: Immediately Prior to MRI and Immediately after MRI). The study lists 3 primary outcomes in all. 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 NCT07155135, which also lists 14 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 4 Sep 2025.