Cardiac ArrhythmiaNCT02807948
SJM MRI Diagnostic Imaging Registry (IDE)
A study testing Pacemaker, ICD, or CRT device in people with Cardiac Arrhythmia, run by Abbott Medical Devices at 58 sites in United States.
Trial summary
This study is a prospective, non-randomized, multi-center study of subjects implanted with an SJM pacemakers, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices who are clinically indicated for a non-thoracic MRI scan. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrhythmia
- What is being tested?
- Pacemaker, ICD, or CRT device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 58 sitesUnited States
- Study dates
- Jun 2016to 31 Jan 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient is implanted with a market-released St. Jude Medical pacemaker, ICD, or CRT current generation device listed in the study protocol and any market-released pacing or defibrillation lead.
- Patient's device and all leads must be implanted for at least 6 weeks prior to the scheduled date of the MRI.
- Patient has a clinical indication for a non-thoracic MRI scan, where MRI is the imaging modality of choice that will give adequate results to manage the patient.
- Patient is scheduled for a non-thoracic MRI scan up to 1.5T.
- Patient has a pacemaker, ICD, or CRT device implanted pectorally.
- Patient has the ability to provide informed consent for study participation and be willing and able to comply with the study procedures.
- Patient is 18 years or above, or of legal age to give informed consent specific to state and national law.
Who cannot join
- Patient has an ICD/CRT-D and is pacemaker dependent
- Capture threshold is greater than 2.5 volts at 0.5 ms for RA and RV leads
- Pacing lead impedance is NOT within range (i.e. ≥ 200 and ≤ 2000 ohms)
- High voltage lead impedance (HVLI) is NOT within range (i.e. ≥ 20 and ≤ 200 ohms)
- Patient has a device generator battery voltage at elective replacement interval (ERI)
- Patient has another existing active implanted medical device (e.g. neurostimulator, infusion pump, etc.) that has MR labeling that will not allow the MRI scans to be completed.
Show all 13Show fewer
- Patient has other non-MRI compatible device or material implanted
- NOTE:
- MRI compatible knee replacements, hip replacements, stents, etc. may be included as long as the labeling of these devices allow MRI scans conducted per this protocol
- MRI compatible mechanical, prosthetic, and bioprosthetic heart valves may be included as long as the labeling of these devices allow for MRI scans conducted per this protocol
- Non-removable dental implants may be included
- Patient has a lead extender, adaptor, or capped/abandoned lead
- Patient is pregnant
Trial locations and contacts
58 sites in 1 country.
58 sites in 1 country
United States58 sites
Lehigh Valley Hospital - 17th Street
Allentown, Pennsylvania, 19118
King's Daughters Medical Center
Ashland, Kentucky, 25704
Piedmont Athens Regional Medical Center
Athens, Georgia, 30606
McLaren Health Care Corporation
Auburn Hills, Michigan, 48326
Quest Imaging
Bakersfield, California, 93311
Overlake Hospital Medical Center
Bellevue, Washington, 98004
Suburban Hospital
Bethesda, Maryland, 20814
Cardiac Arrhythmia Services
Boca Raton, Florida, 33422
Raymond Schaerf, MD
Burbank, California, 91505
Trident Medical Center
Charleston, South Carolina, 29406
Erlanger Medical Center
Chattanooga, Tennessee, 37403
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Advanced Radiology
Columbia, Missouri, 65201
Ohio State University
Columbus, Ohio, 43210
John Muir Medical Center
Concord, California, 94520
Samaritan Heart & Vascular Institute - Cardiology Dept.
Corvallis, Oregon, 97330
Geisinger Medical Center
Danville, Pennsylvania, 17822-2150
St. Helena Hospital
Deer Park, California, 94576
Denville Diagnostics and Open MRI LLC
Denville, New Jersey, 07834
Oregon Medical Group
Eugene, Oregon, 97401
Baylor All Saints Medical Center at Fort Worth
Fort Worth, Texas, 76104
Cardiovascular Consultants Heart Center
Fresno, California, 93720
Hartford Hospital
Hartford, Connecticut, 06102
Community Heart and Vascular
Indianapolis, Indiana, 46250
Baptist Medical Center
Jackson, Mississippi, 39202
St. Bernards
Jonesboro, Arkansas, 72401
Jupiter Medical Center
Jupiter, Florida, 33458
Kansas University Medical Center
Kansas City, Kansas, 66160
St. Luke's Hospital
Kansas City, Missouri, 64111
Kearney Regional Medical Center
Kearney, Nebraska, 68845
St. Mary Medical Center
Langhorne, Pennsylvania, 19047
South Denver Cardiology Associates PC
Littleton, Colorado, 80120
Medical Center of the Rockies
Loveland, Colorado, 80538
Lynchburg General Hospital
Lynchburg, Virginia, 24501
Aurora Medical Group
Milwaukee, Wisconsin, 53215
Christiana Hospital
Newark, Delaware, 19718
Newport Diagnostic Center
Newport Beach, California, 92660
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Pro Health Advance Imaging
North Hollywood, California, 91602
Florida Hospital
Orlando, Florida, 32803
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
Allegheny Singer Research Institute
Pittsburgh, Pennsylvania, 15212
Providence St. Vincent Medical Center
Portland, Oregon, 97225
Eisenhower Medical Center
Rancho Mirage, California, 92270
Borg and Ide Imaging
Rochester, New York, 14618
St. Francis Hospital
Roslyn, New York, 11576
St. Mary's Medical Center
San Francisco, California, 94117
Sansum Clinic - Santa Barbara Medical Foundation
Santa Barbara, California, 93105
Donald Guthrie Foundation for Education and Research
Sayre, Pennsylvania, 18840
Scottsdale Medical Imaging
Scottsdale, Arizona, 85258
Swedish Medical Center - Heart & Vascular
Seattle, Washington, 98122
LSU Health Sciences Center
Shreveport, Louisiana, 71130
Prairie Education and Research Cooperative
Springfield, Illinois, 62701
Mercy Hospital St. Louis
St Louis, Missouri, 63141
Washington Adventist Hospital
Takoma Park, Maryland, 20912
University of Arizona
Tucson, Arizona, 85719
East Texas Medical Center
Tyler, Texas, 75701
Novant Clinical Research Institute
Winston-Salem, North Carolina, 27103
About this study
Official title: A Clinical Evaluation of the Diagnostic Utility of MRI Scans in Patients Implanted With St. Jude Medical Pacemakers, Implantable Cardioverter Defibrillator, and Cardiac Resynchronization Therapy Devices.
This study is a prospective, non-randomized, multi-center study of subjects implanted with an SJM pacemakers, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices who are clinically indicated for a non-thoracic MRI scan.
Read the detailed description
This study will be performed as part of a regulated, prospective, non-randomized, multi-center clinical study.
Subjects will be enrolled, undergo a clinically-indicated MRI scan, and have an assessment of adverse events, device measurements, and clinical utility of the MRI scan images.
- Conditions
- Cardiac Arrhythmia
- Being tested
- Pacemaker, ICD, or CRT device
- Keywords
- MRI Scan, pacemakers, ICD, CRT
- Medical subject headings
- Arrhythmias, Cardiac, Creatine deficiency, X-linked
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacemaker, ICD, or CRT deviceDevice
MRI Scans on SJM device implanted subjects for clinical purpose
| Study group | Role | What they receive |
|---|---|---|
| Pacemaker, ICD, or CRT device patients | Other | Subjects who need a non-thoracic clinically indicated scan Receives: Device: Pacemaker, ICD, or CRT device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of MRI Scans From Pacemakers or CRT-Ps Providing Sufficient Image Quality to Allow for a Diagnostic Interpretation.
Based on the ability of the radiologist to read and provide a diagnosis/report.
Measured: 1 month
The Proportion of MRI Scans From ICDs or CRT-Ds Providing Sufficient Image Quality to Allow for a Diagnostic Interpretation.
Based on the ability of the radiologist to read and provide a diagnosis/report.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startJun 2016
- Primary completion31 Dec 2017
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiac ArrhythmiaStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Grant Kim, Study director, Abbott Medical Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02807948
- Sponsor's protocol ID
- SJM-CIP-10130
- Status last verified
- Aug 2019
- First submitted
- 17 Jun 2016
- Last updated
- 26 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of the Diagnostic Utility of MRI Scans in Patients Implanted With St. Jude Medical Pacemakers, Implantable Cardioverter Defibrillator, and Cardiac Resynchronization Therapy Devices.
- ClinicalTrials.gov ID
- NCT02807948
- Acronym / sponsor ID
- SJM-CIP-10130
- Conditions
- Cardiac Arrhythmia
- Keywords
- MRI Scan, pacemakers, ICD, CRT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jun 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 21 Jun 2016 (estimated)
- Results
- Posted 26 Aug 2019
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, multi-center study of subjects implanted with an SJM pacemakers, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices who are clinically indicated for a non-thoracic MRI scan.
Detailed description
This study will be performed as part of a regulated, prospective, non-randomized, multi-center clinical study.
Subjects will be enrolled, undergo a clinically-indicated MRI scan, and have an assessment of adverse events, device measurements, and clinical utility of the MRI scan images.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pacemaker, ICD, or CRT device patients | Other | Device: Pacemaker, ICD, or CRT deviceSubjects who need a non-thoracic clinically indicated scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient is implanted with a market-released St. Jude Medical pacemaker, ICD, or CRT current generation device listed in the study protocol and any market-released pacing or defibrillation lead.
- Patient's device and all leads must be implanted for at least 6 weeks prior to the scheduled date of the MRI.
- Patient has a clinical indication for a non-thoracic MRI scan, where MRI is the imaging modality of choice that will give adequate results to manage the patient.
- Patient is scheduled for a non-thoracic MRI scan up to 1.5T.
- Patient has a pacemaker, ICD, or CRT device implanted pectorally.
Key exclusion criteria (13 listed)
- Patient has an ICD/CRT-D and is pacemaker dependent
- Capture threshold is greater than 2.5 volts at 0.5 ms for RA and RV leads
- Pacing lead impedance is NOT within range (i.e. ≥ 200 and ≤ 2000 ohms)
- High voltage lead impedance (HVLI) is NOT within range (i.e. ≥ 20 and ≤ 200 ohms)
- Patient has a device generator battery voltage at elective replacement interval (ERI)
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 |
|---|---|---|
| Pacemaker, ICD, or CRT deviceMRI Scans on SJM device implanted subjects for clinical purpose | Device | Pacemaker, ICD, or CRT device patients |
Primary outcome
The Proportion of MRI Scans From Pacemakers or CRT-Ps Providing Sufficient Image Quality to Allow for a Diagnostic Interpretation.
Time frame: 1 month
Based on the ability of the radiologist to read and provide a diagnosis/report.
The Proportion of MRI Scans From ICDs or CRT-Ds Providing Sufficient Image Quality to Allow for a Diagnostic Interpretation.
Time frame: 1 month
Based on the ability of the radiologist to read and provide a diagnosis/report.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Cardiac Arrhythmia
RecruitingObservational study
BOdygUardian MOnitoriNg for ReCurrencE of AF
Atrial Fibrillation (AF)
Active, not recruiting
Safety and Efficacy of Conscious Sedation Versus General Anesthesia in Pulsed-Field Ablation for Paroxysmal Atrial Fibrillation
Atrial Fibrillation (Paroxysmal)
Active, not recruitingObservational study
Resumption of Anticoagulation After Major Gastrointestinal Bleeding in Patients With Atrial Fibrillation
Atrial Fibrillation (AF), Gastrointestinal Bleeding
Recruiting
A Comparison of Pulsed Field Ablation (PFA) vs Cryoablation for Atrial Fibrillation Under Deep Sedation
Atrial Fibrillation (AF)
Not yet recruiting
CATCH AF - Atrial Fibrillation Detection in Cryptogenic Stroke
Atrial Fibrillation (AF)
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.
Grant Kim study director
Abbott Medical Devices
58 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacemaker, ICD, or CRT device in people with Cardiac Arrhythmia, run by Abbott Medical Devices at 58 sites 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 7 inclusion and 13 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 26 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites 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?
Yes. Results are posted in the registry (first posted 26 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Proportion of MRI Scans From Pacemakers or CRT-Ps Providing Sufficient Image Quality to Allow for a Diagnostic Interpretation. (time frame: 1 month). The study lists 2 primary outcomes in all. 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 26 Aug 2019.