Arrhythmias, CardiacNCT02906189
Safety of Magnetic Resonance Imaging in Non-MRI Conditional Pacemakers and ICD Devices
An observational study of Arrhythmias, Cardiac, run by Banner Health at 1 site in United States.
Trial summary
The primary objective of the study is to determine the safety of MRI in patients with non-MRI conditional pacemakers. The secondary objective is to determine if there are clinically relevant parameter changes in the devices. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Arrhythmias, Cardiac
- What is being tested?
- MRI
- Type of treatment
- Surgery or procedure
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Sep 2021
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with non-MRI conditional pacemakers and ICDs referred for clinically indicated MRI scans.
Inclusion Criteria. All patients with non-MRI conditional pacemakers and ICDs between the ages of 18-85 will be eligible to participate. Medical records will be reviewed to confirm the date and make/model of device implanted. Ordering physician discusses the MRI request with radiologist, documenting that there is no appropriate alternate imaging test. Patient must have an appointment with a cardiologist/electrophysiologist prior to MRI. Banner Health policy for standard of care guidelines involving patients receiving MRI's will be followed.
Exclusion Criteria. Patients will be excluded from MRI based on the Department of Radiology protocol. Additional exclusion criteria include: ICD and pacemaker dependent, Pacemaker inserted before 2002, Epicardial leads, fractured leads, abandoned leads, or temporary pacemakers (post-coronary artery bypass graft temporary epicardial pacing wires are acceptable), Patient not awake or unable communicate, Battery voltage at elective replacement interval, implanted non-MRI conditional device (other than pacemaker/ICD).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Banner University Medical Center Phoenix
Phoenix, Arizona, 85004
Michael Morris, MD, 602-839-4850, michael.morris@bannerhealth.com
About this study
The primary objective of the study is to determine the safety of MRI in patients with non-MRI conditional pacemakers. The secondary objective is to determine if there are clinically relevant parameter changes in the devices.
- Conditions
- Arrhythmias, Cardiac
- Being tested
- MRI
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Death during the MRI scan
Measured: Immediate
Secondary outcomes (11)
Decrease in battery voltage >0.04v
Measured: 6 months
Change in pacing lead impedance ≥ 50 Ω
Measured: 6 months
Change in high-voltage lead impedance ≥ 3 Ω
Measured: 6 months
Increase in pacing threshold ≥ 0.50 V @ 0.4 ms
Measured: 6 months
Decrease in P wave measurement ≥ 50%
Measured: 6 months
Decrease in R wave measurement ≥ 25%
Measured: 6 months
Generator failure requiring immediate replacement
Measured: Immediate
Lead failure requiring immediate replacement
Measured: Immediate
New onset atrial or ventricular arrhythmia during MRI
Measured: Immediate
Loss of pacemaker capture during MRI
Measured: Immediate
Electrical reset of the device
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Banner Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Morris, Banner Health
- Investigators
- Michael Morris, MD, Principal investigator, Banner University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906189
- Sponsor's protocol ID
- 1608820677
- Status last verified
- Sep 2016
- First submitted
- 3 Sep 2016
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Magnetic Resonance Imaging in Non-MRI Conditional Pacemakers and ICD Devices
- ClinicalTrials.gov ID
- NCT02906189
- Acronym / sponsor ID
- 1608820677
- Conditions
- Arrhythmias, Cardiac
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Banner HealthUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 20 Sep 2016 (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.
The primary objective of the study is to determine the safety of MRI in patients with non-MRI conditional pacemakers. The secondary objective is to determine if there are clinically relevant parameter changes in the devices.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non-MRI conditional pacemakers and ICDs referred for clinically indicated MRI scans.
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 | Radiation | – |
Primary outcome
Death during the MRI scan
Time frame: Immediate
11 secondary outcomes
Decrease in battery voltage >0.04v
Time frame: 6 months
Change in pacing lead impedance ≥ 50 Ω
Time frame: 6 months
Change in high-voltage lead impedance ≥ 3 Ω
Time frame: 6 months
Increase in pacing threshold ≥ 0.50 V @ 0.4 ms
Time frame: 6 months
Decrease in P wave measurement ≥ 50%
Time frame: 6 months
Decrease in R wave measurement ≥ 25%
Time frame: 6 months
Generator failure requiring immediate replacement
Time frame: Immediate
Lead failure requiring immediate replacement
Time frame: Immediate
New onset atrial or ventricular arrhythmia during MRI
Time frame: Immediate
Loss of pacemaker capture during MRI
Time frame: Immediate
Electrical reset of the device
Time frame: Immediate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
- Individual participant dataSharing planned: No
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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 Morris, MD principal investigator
Banner University Medical Center
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 Banner 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?
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: status not confirmed, as of the sponsor's last update on 20 Sep 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Morris, MD (602-839-4850, michael.morris@bannerhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death during the MRI scan (time frame: Immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Sep 2016.