Arrhythmias, CardiacNCT01999751
Study to Monitor Patients With Pacemakers or ICDs Who Undergo MRI Scans
An observational study of Arrhythmias, Cardiac, run by Essentia Health at 1 site in United States.
Trial summary
This study is a prospective, non-randomized, unblinded case series of patients with permanent pacemakers and implantable cardioverter-defibrillators undergoing medically-required magnetic resonance imaging (MRI) scanning, at St. Mary's Medical Center, Essentia Health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmias, Cardiac
- What is being tested?
- MRI Scan
- Type of treatment
- Medical device
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to 11 Apr 2018
- How long will I take part?
- 1 Year
- 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: Any person followed at St. Mary's Medical Center, Duluth, MN, with a permanent pacemaker or implantable cardioverter-defibrillator implanted for at least 6 weeks, referred for a medically-required MRI scan by a physician or provider not participating in the trial. If patients elect not to participate, they may still receive an MRI and will sign the clinical consent. If they elect not to have an MRI, they will be referred back to the ordering provider to discuss other options.
Who may be able to join
- Permanent Pacemaker or ICD implanted for at least 6 weeks
- Referred for medically-required MRI scan
- Age greater than or equal to 18 years
Who cannot join
- ICD market released before 2001 including GDT Ventak-AV, GDT MINI-II, GDT MINI-IV, GDT MINI-III, GDT Prizm, GDT Prizm-2 and MDT GEM-I series
- Epicardial lead or subcutaneous array
- Device has reached elective replacement indicator (ERI) or end of life (EOL)
- Other usual contraindications to MRI scanning
- Known or suspected lead fracture or abandoned lead
- Pacemaker dependent patients with an ICD that cannot be programmed to asynchronous pacing (DOO/VOO)
- Clinical factors that are deemed by the PI or Sub-I to increase the participant's risk above an acceptable clinical threshold
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SMDC CRM-MRI Prospective Case Series
This study is a prospective, non-randomized, unblinded case series of patients with permanent pacemakers and implantable cardioverter-defibrillators undergoing medically-required magnetic resonance imaging (MRI) scanning, at St. Mary's Medical Center, Essentia Health. Patients will be enrolled over a 60-month period and followed for 12 months, with data collected to evaluate the study's primary endpoint, change in pacing thresholds over time, as well as a series of secondary endpoints, including: adverse events, symptoms, need to make pacemaker programming changes, and possible artifacts created by the pacemaker systems on the MRI scans. This study will allow for carefully monitoring of the safety MRI scanning in this population and improve practice models and protocols in the future.
Read the detailed description
General Approach: This study is a prospective, non-randomized, unblinded case series of patients with permanent pacemakers or implantable cardioverter-defibrillators (ICDs) undergoing medically-required MRI scanning, followed for a 12 month period. MRI scanning will be performed using accepted, standard protocols using FDA-approved equipment.
Methods and Materials: Patients will be enrolled over a 60-month period by the Principal Investigator (PI) and/or Sub-Investigator (Sub-I), at the Regional Heart Center, located at St. Mary's Medical Center, Essentia Health, Duluth, MN, during evaluations for medically-required MRI scanning. Eligible patients includes any person with a permanent pacemaker or ICD implanted for at least 6 weeks, referred for a medically-required MRI scan by a physician not participating in the trial. ICD generators must have been market released after 2001. Both pacemaker dependent and non-dependent patients are eligible. The primary endpoint is any change greater than 1 V at a pulse width of 0.5 ms in a pacemaker or ICD lead at any time within 12 months of the MRI scan.
On the day of the MRI scan, the pacemaker or ICD will be interrogated and programmed per usual practice at Essentia Health for patients undergoing an MRI scan with device in place. Three separate baseline capture threshold measurements (V) will be obtained at a fixed pulse width of 0.5 msec. Three separate baseline measurements will also be made of lead pacing impedances (Ohms) and sensed P- or R-waves (mV) using programmer default methods. Histograms will be cleared. Leads will be programmed to bipolar modality. If the patient is not device dependent, the device will be programmed to ODO/OVO/OAO mode (monitor only) if available, otherwise it will be reprogrammed to DDI or VVI mode with a lower rate of 40 bpm with pacing outputs programmed to subthreshold levels in all leads. If the participant is device dependent, the device will be programmed to an asynchronous pacing modality (DOO/VOO) with maximum pacing output. If the patient has an ICD, therapies will be disabled. The attending investigator may alter the pacing modality during the course of the scan if he or she deems it necessary to maximize patient safety or comfort. Rate responsiveness, any rate enhancements including Ventricular Rate Regulation mode, and magnet mode will be turned off.
During MRI scanning, resuscitation equipment will be available. If the participant is pacemaker dependent, the study PI or sub-I must be in the MRI suite during the scan. If the participant is not pacemaker dependent, then a pacemaker nurse will be in the MRI suite to perform pre- and post-checks, and an electrophysiologist will be available in the building for questions and troubleshooting. Patients will be asked to report all symptoms including: palpitations; pain; heat or warmth sensation; device movement; or light-headedness.
Scans will be performed using usual protocols with standard peak Specific Absorption Rate (SAR) limitations for the scan. The MRI scans will be evaluated for any artifact created by the pacemaker system. During the scan, continuous electrocardiographic and pulse oxymetry with waveform monitoring will be performed using usual protocols. Following the scan, repeat thresholds will be performed for each lead and histograms will be obtained. Three separate capture threshold measurements (V) will be obtained immediately after the patient leaves the scanner room at a fixed pulse width of 0.5 msec. Three separate measurements will also be made immediately following the scan of the lead pacing impedances (Ohms) and sensed P- or R-waves (mV) using programmer default methods. Participants who are pacemaker dependent will undergo a one-hour post-scan check using the same threshold protocol. These one-hour post scan measurements will be performed either in the pacemaker clinic if the patient is an outpatient or in the hospital if the patient is an inpatient. Any stored events detected on the device as electromagnetic interference (EMI) artifact during the scan may be retrieved and stored to diskette for later analysis. The pacemaker or ICD will be reprogrammed to original settings prior to discharge from the MRI suite unless the attending investigator deems it necessary to alter device setting to maximize patient safety or comfort. If the patient has an ICD, the capacitor will be reformed and charge time noted prior to dismissal from the MRI suite.
Patients will be followed up in the pacemaker clinic at 3 and 12 months from the MRI scan using usual clinic protocols for device follow-up. If a patient undergoes a second MRI scan, the follow-up schedule will be set based upon the most recent MRI scan.
- Conditions
- Arrhythmias, Cardiac
- Being tested
- MRI Scan
- Keywords
- Magnetic Resonance Imaging, Pacemaker, Artificial, Defibrillators, Implantable
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI ScanDevice
Clinically indicated MRI scan of patients with pacemaker or implantable cardioverter-defibrillator in situ.
| Study group | Role | What they receive |
|---|---|---|
| MRI Scan | Patients with implantable cardioverter-defibrillator or pacemaker who undergo an MRI scan Receives: Device: MRI Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pacing threshold increase
Any change greater than 1 V at a pulse width of 0.5 msec in a pacemaker or implantable cardioverter-defibrillator lead at any time within 12 months of the MRI scan
Measured: 12 months
Secondary outcomes (2)
Ectopy
Increased cardiac ectopy at the time of the MRI scan
Measured: 1 hour
Pacemaker reprogramming
Unanticipated pacemaker or implantable cardioverter-defibrillator reprogramming because of alterations in device behavior possibly related to the MRI scan
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2013 (estimated)
- Study startOct 2012
- Primary completion2 Apr 2018
- Study completion11 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Arrhythmias, CardiacStudies 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
- Prospective
- Enrolment
- 124 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Essentia Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Mollerus, Essentia Health
- Investigators
- Michael E Mollerus, MD, Principal investigator, Essentia Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01999751
- Sponsor's protocol ID
- EH12274
- Status last verified
- Apr 2018
- First submitted
- 26 Nov 2013
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Hayes DL, Holmes DR Jr, Gray JE. Effect of 1.5 tesla nuclear magnetic resonance imaging scanner on implanted permanent pacemakers. J Am Coll Cardiol. 1987 Oct;10(4):782-6. doi: 10.1016/s0735-1097(87)80270-x.
PubMed 3655146Goldschlager N, Epstein A, Friedman P, Gang E, Krol R, Olshansky B; North American Society of Pacing and Electrophysiology (NASPE) Practice Guideline Committee. Environmental and drug effects on patients with pacemakers and implantable cardioverter/defibrillators: a practical guide to patient treatment. Arch Intern Med. 2001 Mar 12;161(5):649-55. doi: 10.1001/archinte.161.5.649. No abstract available.
PubMed 11231696Martin ET, Coman JA, Shellock FG, Pulling CC, Fair R, Jenkins K. Magnetic resonance imaging and cardiac pacemaker safety at 1.5-Tesla. J Am Coll Cardiol. 2004 Apr 7;43(7):1315-24. doi: 10.1016/j.jacc.2003.12.016.
PubMed 15063447Erlebacher JA, Cahill PT, Pannizzo F, Knowles RJ. Effect of magnetic resonance imaging on DDD pacemakers. Am J Cardiol. 1986 Feb 15;57(6):437-40. doi: 10.1016/0002-9149(86)90768-x.
PubMed 3946261Fetter J, Aram G, Holmes DR Jr, Gray JE, Hayes DL. The effects of nuclear magnetic resonance imagers on external and implantable pulse generators. Pacing Clin Electrophysiol. 1984 Jul;7(4):720-7. doi: 10.1111/j.1540-8159.1984.tb05602.x.
PubMed 6205375Sommer T, Vahlhaus C, Lauck G, von Smekal A, Reinke M, Hofer U, Block W, Traber F, Schneider C, Gieseke J, Jung W, Schild H. MR imaging and cardiac pacemakers: in-vitro evaluation and in-vivo studies in 51 patients at 0.5 T. Radiology. 2000 Jun;215(3):869-79. doi: 10.1148/radiology.215.3.r00jn08869.
PubMed 10831713Shellock FG, O'Neil M, Ivans V, Kelly D, O'Connor M, Toay L, Crues JV. Cardiac pacemakers and implantable cardioverter defibrillators are unaffected by operation of an extremity MR imaging system. AJR Am J Roentgenol. 1999 Jan;172(1):165-70. doi: 10.2214/ajr.172.1.9888762.
PubMed 9888762Roguin A, Zviman MM, Meininger GR, Rodrigues ER, Dickfeld TM, Bluemke DA, Lardo A, Berger RD, Calkins H, Halperin HR. Modern pacemaker and implantable cardioverter/defibrillator systems can be magnetic resonance imaging safe: in vitro and in vivo assessment of safety and function at 1.5 T. Circulation. 2004 Aug 3;110(5):475-82. doi: 10.1161/01.CIR.0000137121.28722.33. Epub 2004 Jul 26.
PubMed 15277324Nazarian S, Roguin A, Zviman MM, Lardo AC, Dickfeld TL, Calkins H, Weiss RG, Berger RD, Bluemke DA, Halperin HR. Clinical utility and safety of a protocol for noncardiac and cardiac magnetic resonance imaging of patients with permanent pacemakers and implantable-cardioverter defibrillators at 1.5 tesla. Circulation. 2006 Sep 19;114(12):1277-84. doi: 10.1161/CIRCULATIONAHA.105.607655. Epub 2006 Sep 11.
PubMed 16966586Gimbel JR, Kanal E, Schwartz KM, Wilkoff BL. Outcome of magnetic resonance imaging (MRI) in selected patients with implantable cardioverter defibrillators (ICDs). Pacing Clin Electrophysiol. 2005 Apr;28(4):270-3. doi: 10.1111/j.1540-8159.2005.09520.x.
PubMed 15826257Mollerus M, Albin G, Lipinski M, Lucca J. Magnetic resonance imaging of pacemakers and implantable cardioverter-defibrillators without specific absorption rate restrictions. Europace. 2010 Jul;12(7):947-51. doi: 10.1093/europace/euq092. Epub 2010 Mar 30.
PubMed 20353963Nazarian S, Hansford R, Roguin A, Goldsher D, Zviman MM, Lardo AC, Caffo BS, Frick KD, Kraut MA, Kamel IR, Calkins H, Berger RD, Bluemke DA, Halperin HR. A prospective evaluation of a protocol for magnetic resonance imaging of patients with implanted cardiac devices. Ann Intern Med. 2011 Oct 4;155(7):415-24. doi: 10.7326/0003-4819-155-7-201110040-00004.
PubMed 21969340
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMDC CRM-MRI Prospective Case Series
- ClinicalTrials.gov ID
- NCT01999751
- Acronym / sponsor ID
- EH12274
- Conditions
- Arrhythmias, Cardiac
- Keywords
- Magnetic Resonance Imaging, Pacemaker, Artificial, Defibrillators, Implantable
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Essentia HealthUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- 2 Apr 2018 (actual)
- Study completion
- 11 Apr 2018 (actual)
- First posted
- 3 Dec 2013 (estimated)
- 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 a prospective, non-randomized, unblinded case series of patients with permanent pacemakers and implantable cardioverter-defibrillators undergoing medically-required magnetic resonance imaging (MRI) scanning, at St. Mary's Medical Center, Essentia Health. Patients will be enrolled over a 60-month period and followed for 12 months, with data collected to evaluate the study's primary endpoint, change in pacing thresholds over time, as well as a series of secondary endpoints, including: adverse events, symptoms, need to make pacemaker programming changes, and possible artifacts created by the pacemaker systems on the MRI scans. This study will allow for carefully monitoring of the safety MRI scanning in this population and improve practice models and protocols in the future.
Detailed description
General Approach: This study is a prospective, non-randomized, unblinded case series of patients with permanent pacemakers or implantable cardioverter-defibrillators (ICDs) undergoing medically-required MRI scanning, followed for a 12 month period. MRI scanning will be performed using accepted, standard protocols using FDA-approved equipment.
Methods and Materials: Patients will be enrolled over a 60-month period by the Principal Investigator (PI) and/or Sub-Investigator (Sub-I), at the Regional Heart Center, located at St. Mary's Medical Center, Essentia Health, Duluth, MN, during evaluations for medically-required MRI scanning. Eligible patients includes any person with a permanent pacemaker or ICD implanted for at least 6 weeks, referred for a medically-required MRI scan by a physician not participating in the trial. ICD generators must have been market released after 2001. Both pacemaker dependent and non-dependent patients are eligible. The primary endpoint is any change greater than 1 V at a pulse width of 0.5 ms in a pacemaker or ICD lead at any time within 12 months of the MRI scan.
On the day of the MRI scan, the pacemaker or ICD will be interrogated and programmed per usual practice at Essentia Health for patients undergoing an MRI scan with device in place. Three separate baseline capture threshold measurements (V) will be obtained at a fixed pulse width of 0.5 msec. Three separate baseline measurements will also be made of lead pacing impedances (Ohms) and sensed P- or R-waves (mV) using programmer default methods. Histograms will be cleared. Leads will be programmed to bipolar modality. If the patient is not device dependent, the device will be programmed to ODO/OVO/OAO mode (monitor only) if available, otherwise it will be reprogrammed to DDI or VVI mode with a lower rate of 40 bpm with pacing outputs programmed to subthreshold levels in all leads. If the participant is device dependent, the device will be programmed to an asynchronous pacing modality (DOO/VOO) with maximum pacing output. If the patient has an ICD, therapies will be disabled. The attending investigator may alter the pacing modality during the course of the scan if he or she deems it necessary to maximize patient safety or comfort. Rate responsiveness, any rate enhancements including Ventricular Rate Regulation mode, and magnet mode will be turned off.
During MRI scanning, resuscitation equipment will be available. If the participant is pacemaker dependent, the study PI or sub-I must be in the MRI suite during the scan. If the participant is not pacemaker dependent, then a pacemaker nurse will be in the MRI suite to perform pre- and post-checks, and an electrophysiologist will be available in the building for questions and troubleshooting. Patients will be asked to report all symptoms including: palpitations; pain; heat or warmth sensation; device movement; or light-headedness.
Scans will be performed using usual protocols with standard peak Specific Absorption Rate (SAR) limitations for the scan. The MRI scans will be evaluated for any artifact created by the pacemaker system. During the scan, continuous electrocardiographic and pulse oxymetry with waveform monitoring will be performed using usual protocols. Following the scan, repeat thresholds will be performed for each lead and histograms will be obtained. Three separate capture threshold measurements (V) will be obtained immediately after the patient leaves the scanner room at a fixed pulse width of 0.5 msec. Three separate measurements will also be made immediately following the scan of the lead pacing impedances (Ohms) and sensed P- or R-waves (mV) using programmer default methods. Participants who are pacemaker dependent will undergo a one-hour post-scan check using the same threshold protocol. These one-hour post scan measurements will be performed either in the pacemaker clinic if the patient is an outpatient or in the hospital if the patient is an inpatient. Any stored events detected on the device as electromagnetic interference (EMI) artifact during the scan may be retrieved and stored to diskette for later analysis. The pacemaker or ICD will be reprogrammed to original settings prior to discharge from the MRI suite unless the attending investigator deems it necessary to alter device setting to maximize patient safety or comfort. If the patient has an ICD, the capacitor will be reformed and charge time noted prior to dismissal from the MRI suite.
Patients will be followed up in the pacemaker clinic at 3 and 12 months from the MRI scan using usual clinic protocols for device follow-up. If a patient undergoes a second MRI scan, the follow-up schedule will be set based upon the most recent MRI scan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI Scan | – | Device: MRI ScanPatients with implantable cardioverter-defibrillator or pacemaker who undergo an MRI scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any person followed at St. Mary's Medical Center, Duluth, MN, with a permanent pacemaker or implantable cardioverter-defibrillator implanted for at least 6 weeks, referred for a medically-required MRI scan by a physician or provider not participating in the trial. If patients elect not to participate, they may still receive an MRI and will sign the clinical consent. If they elect not to have an MRI, they will be referred back to the ordering provider to discuss other options.
Key inclusion criteria (3 listed)
- Permanent Pacemaker or ICD implanted for at least 6 weeks
- Referred for medically-required MRI scan
- Age greater than or equal to 18 years
Key exclusion criteria (7 listed)
- ICD market released before 2001 including GDT Ventak-AV, GDT MINI-II, GDT MINI-IV, GDT MINI-III, GDT Prizm, GDT Prizm-2 and MDT GEM-I series
- Epicardial lead or subcutaneous array
- Device has reached elective replacement indicator (ERI) or end of life (EOL)
- Other usual contraindications to MRI scanning
- Known or suspected lead fracture or abandoned lead
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 |
|---|---|---|
| MRI ScanClinically indicated MRI scan of patients with pacemaker or implantable cardioverter-defibrillator in situ. | Device | MRI Scan |
Primary outcome
Pacing threshold increase
Time frame: 12 months
Any change greater than 1 V at a pulse width of 0.5 msec in a pacemaker or implantable cardioverter-defibrillator lead at any time within 12 months of the MRI scan
2 secondary outcomes
Ectopy
Time frame: 1 hour
Pacemaker reprogramming
Time frame: 12 months
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 12 Apr 2018.
- Background: PubMed 3655146Hayes DL, Holmes DR Jr, Gray JE. Effect of 1.5 tesla nuclear magnetic resonance imaging scanner on implanted permanent pacemakers. J Am Coll Cardiol. 1987 Oct;10(4):782-6. doi: 10.1016/s0735-1097(87)80270-x.
- Background: PubMed 11231696Goldschlager N, Epstein A, Friedman P, Gang E, Krol R, Olshansky B; North American Society of Pacing and Electrophysiology (NASPE) Practice Guideline Committee. Environmental and drug effects on patients with pacemakers and implantable cardioverter/defibrillators: a practical guide to patient treatment. Arch Intern Med. 2001 Mar 12;161(5):649-55. doi: 10.1001/archinte.161.5.649. No abstract available.
- Background: PubMed 15063447Martin ET, Coman JA, Shellock FG, Pulling CC, Fair R, Jenkins K. Magnetic resonance imaging and cardiac pacemaker safety at 1.5-Tesla. J Am Coll Cardiol. 2004 Apr 7;43(7):1315-24. doi: 10.1016/j.jacc.2003.12.016.
- Background: PubMed 3946261Erlebacher JA, Cahill PT, Pannizzo F, Knowles RJ. Effect of magnetic resonance imaging on DDD pacemakers. Am J Cardiol. 1986 Feb 15;57(6):437-40. doi: 10.1016/0002-9149(86)90768-x.
- Background: PubMed 6205375Fetter J, Aram G, Holmes DR Jr, Gray JE, Hayes DL. The effects of nuclear magnetic resonance imagers on external and implantable pulse generators. Pacing Clin Electrophysiol. 1984 Jul;7(4):720-7. doi: 10.1111/j.1540-8159.1984.tb05602.x.
- Background: PubMed 10831713Sommer T, Vahlhaus C, Lauck G, von Smekal A, Reinke M, Hofer U, Block W, Traber F, Schneider C, Gieseke J, Jung W, Schild H. MR imaging and cardiac pacemakers: in-vitro evaluation and in-vivo studies in 51 patients at 0.5 T. Radiology. 2000 Jun;215(3):869-79. doi: 10.1148/radiology.215.3.r00jn08869.
- Background: PubMed 9888762Shellock FG, O'Neil M, Ivans V, Kelly D, O'Connor M, Toay L, Crues JV. Cardiac pacemakers and implantable cardioverter defibrillators are unaffected by operation of an extremity MR imaging system. AJR Am J Roentgenol. 1999 Jan;172(1):165-70. doi: 10.2214/ajr.172.1.9888762.
- Background: PubMed 15277324Roguin A, Zviman MM, Meininger GR, Rodrigues ER, Dickfeld TM, Bluemke DA, Lardo A, Berger RD, Calkins H, Halperin HR. Modern pacemaker and implantable cardioverter/defibrillator systems can be magnetic resonance imaging safe: in vitro and in vivo assessment of safety and function at 1.5 T. Circulation. 2004 Aug 3;110(5):475-82. doi: 10.1161/01.CIR.0000137121.28722.33. Epub 2004 Jul 26.
- Background: PubMed 16966586Nazarian S, Roguin A, Zviman MM, Lardo AC, Dickfeld TL, Calkins H, Weiss RG, Berger RD, Bluemke DA, Halperin HR. Clinical utility and safety of a protocol for noncardiac and cardiac magnetic resonance imaging of patients with permanent pacemakers and implantable-cardioverter defibrillators at 1.5 tesla. Circulation. 2006 Sep 19;114(12):1277-84. doi: 10.1161/CIRCULATIONAHA.105.607655. Epub 2006 Sep 11.
- Background: PubMed 15826257Gimbel JR, Kanal E, Schwartz KM, Wilkoff BL. Outcome of magnetic resonance imaging (MRI) in selected patients with implantable cardioverter defibrillators (ICDs). Pacing Clin Electrophysiol. 2005 Apr;28(4):270-3. doi: 10.1111/j.1540-8159.2005.09520.x.
- Background: PubMed 20353963Mollerus M, Albin G, Lipinski M, Lucca J. Magnetic resonance imaging of pacemakers and implantable cardioverter-defibrillators without specific absorption rate restrictions. Europace. 2010 Jul;12(7):947-51. doi: 10.1093/europace/euq092. Epub 2010 Mar 30.
- Background: PubMed 21969340Nazarian S, Hansford R, Roguin A, Goldsher D, Zviman MM, Lardo AC, Caffo BS, Frick KD, Kraut MA, Kamel IR, Calkins H, Berger RD, Bluemke DA, Halperin HR. A prospective evaluation of a protocol for magnetic resonance imaging of patients with implanted cardiac devices. Ann Intern Med. 2011 Oct 4;155(7):415-24. doi: 10.7326/0003-4819-155-7-201110040-00004.
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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.
Michael E Mollerus, MD principal investigator
Essentia Health
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 Arrhythmias, Cardiac, run by Essentia Health 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 7 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 12 Apr 2018. 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?
Pacing threshold increase (time frame: 12 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 NCT01999751, which also lists 12 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 12 Apr 2018.