SJM MRI Diagnostic Imaging Registry (IDE)

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02807948
• Collaborator: (none)
• Enrollment: 189
• Locations: 58
• Arm: 1
• Actual Duration (Months): 20
• Patients Per Site: 3.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrhythmia	Device: Pacemaker, ICD, or CRT device	N/A

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

• Study Type: Interventional
• Actual Enrollment: 189 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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.
• Actual Study Start Date: Jun 1, 2016
• Actual Primary Completion Date: Dec 31, 2017
• Actual Study Completion Date: Jan 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: Pacemaker, ICD, or CRT device patients Subjects who need a non-thoracic clinically indicated scan	Device: Pacemaker, ICD, or CRT device; MRI Scans on SJM device implanted subjects for clinical purpose

Outcome Measures

Primary Outcome Measures

1. The Proportion of MRI Scans From Pacemakers or CRT-Ps Providing Sufficient Image Quality to Allow for a Diagnostic Interpretation. [1 month]

   Based on the ability of the radiologist to read and provide a diagnosis/report.

2. The Proportion of MRI Scans From ICDs or CRT-Ds Providing Sufficient Image Quality to Allow for a Diagnostic Interpretation. [1 month]

   Based on the ability of the radiologist to read and provide a diagnosis/report.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. 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.

2. Patient's device and all leads must be implanted for at least 6 weeks prior to the scheduled date of the MRI.

3. 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.

4. Patient is scheduled for a non-thoracic MRI scan up to 1.5T.

5. Patient has a pacemaker, ICD, or CRT device implanted pectorally.

6. Patient has the ability to provide informed consent for study participation and be willing and able to comply with the study procedures.

7. Patient is 18 years or above, or of legal age to give informed consent specific to state and national law.

Exclusion Criteria:

1. Patient has an ICD/CRT-D and is pacemaker dependent

2. Capture threshold is greater than 2.5 volts at 0.5 ms for RA and RV leads

3. Pacing lead impedance is NOT within range (i.e. ≥ 200 and ≤ 2000 ohms)

4. High voltage lead impedance (HVLI) is NOT within range (i.e. ≥ 20 and ≤ 200 ohms)

5. Patient has a device generator battery voltage at elective replacement interval (ERI)

6. 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.

7. 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

1. Patient has a lead extender, adaptor, or capped/abandoned lead

2. Patient is pregnant

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Scottsdale Medical Imaging	Scottsdale	Arizona	United States	85258
2	University of Arizona	Tucson	Arizona	United States	85719
3	St. Bernards	Jonesboro	Arkansas	United States	72401
4	Quest Imaging	Bakersfield	California	United States	93311
5	Raymond Schaerf, MD	Burbank	California	United States	91505
6	John Muir Medical Center	Concord	California	United States	94520
7	St. Helena Hospital	Deer Park	California	United States	94576
8	Cardiovascular Consultants Heart Center	Fresno	California	United States	93720
9	Newport Diagnostic Center	Newport Beach	California	United States	92660
10	Pro Health Advance Imaging	North Hollywood	California	United States	91602
11	Eisenhower Medical Center	Rancho Mirage	California	United States	92270
12	St. Mary's Medical Center	San Francisco	California	United States	94117
13	Sansum Clinic - Santa Barbara Medical Foundation	Santa Barbara	California	United States	93105
14	South Denver Cardiology Associates PC	Littleton	Colorado	United States	80120
15	Medical Center of the Rockies	Loveland	Colorado	United States	80538
16	Hartford Hospital	Hartford	Connecticut	United States	06102
17	Christiana Hospital	Newark	Delaware	United States	19718
18	Cardiac Arrhythmia Services	Boca Raton	Florida	United States	33422
19	Jupiter Medical Center	Jupiter	Florida	United States	33458
20	Florida Hospital	Orlando	Florida	United States	32803
21	Piedmont Athens Regional Medical Center	Athens	Georgia	United States	30606
22	Advocate Lutheran General Hospital	Park Ridge	Illinois	United States	60068
23	Prairie Education and Research Cooperative	Springfield	Illinois	United States	62701
24	Community Heart and Vascular	Indianapolis	Indiana	United States	46250
25	Kansas University Medical Center	Kansas City	Kansas	United States	66160
26	King's Daughters Medical Center	Ashland	Kentucky	United States	25704
27	LSU Health Sciences Center	Shreveport	Louisiana	United States	71130
28	Suburban Hospital	Bethesda	Maryland	United States	20814
29	Washington Adventist Hospital	Takoma Park	Maryland	United States	20912
30	McLaren Health Care Corporation	Auburn Hills	Michigan	United States	48326
31	Baptist Medical Center	Jackson	Mississippi	United States	39202
32	Advanced Radiology	Columbia	Missouri	United States	65201
33	St. Luke's Hospital	Kansas City	Missouri	United States	64111
34	Mercy Hospital St. Louis	Saint Louis	Missouri	United States	63141
35	Kearney Regional Medical Center	Kearney	Nebraska	United States	68845
36	Denville Diagnostics and Open MRI LLC	Denville	New Jersey	United States	07834
37	Borg and Ide Imaging	Rochester	New York	United States	14618
38	St. Francis Hospital	Roslyn	New York	United States	11576
39	Novant Clinical Research Institute	Winston-Salem	North Carolina	United States	27103
40	The Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
41	Ohio State University	Columbus	Ohio	United States	43210
42	Samaritan Heart & Vascular Institute - Cardiology Dept.	Corvallis	Oregon	United States	97330
43	Oregon Medical Group	Eugene	Oregon	United States	97401
44	Providence St. Vincent Medical Center	Portland	Oregon	United States	97225
45	Lehigh Valley Hospital - 17th Street	Allentown	Pennsylvania	United States	19118
46	Geisinger Medical Center	Danville	Pennsylvania	United States	17822-2150
47	St. Mary Medical Center	Langhorne	Pennsylvania	United States	19047
48	Allegheny Singer Research Institute	Pittsburgh	Pennsylvania	United States	15212
49	Donald Guthrie Foundation for Education and Research	Sayre	Pennsylvania	United States	18840
50	Trident Medical Center	Charleston	South Carolina	United States	29406
51	Erlanger Medical Center	Chattanooga	Tennessee	United States	37403
52	Baylor All Saints Medical Center at Fort Worth	Fort Worth	Texas	United States	76104
53	East Texas Medical Center	Tyler	Texas	United States	75701
54	Lynchburg General Hospital	Lynchburg	Virginia	United States	24501
55	Sentara Norfolk General Hospital	Norfolk	Virginia	United States	23507
56	Overlake Hospital Medical Center	Bellevue	Washington	United States	98004
57	Swedish Medical Center - Heart & Vascular	Seattle	Washington	United States	98122
58	Aurora Medical Group	Milwaukee	Wisconsin	United States	53215

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Study Director: Grant Kim, Abbott Medical Devices

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Jun 15, 2017

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT02807948
• Other Study ID Numbers: SJM-CIP-10130
• First Posted: Jun 21, 2016
• Last Update Posted: Aug 26, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Abbott Medical Devices: MRI Scan, pacemakers, ICD, CRT
• Additional relevant MeSH terms: Arrhythmias, Cardiac

Study Results

Participant Flow

Arm/Group Title	Pacemaker or CRT-P Device Patients	ICD or CRT-D Device Patients
Arm/Group Description	Subjects who need a non-thoracic clinically indicated scan Pacemaker or Cardiac Re-synchronization Therapy -Pacemaker (CRT-P) device: MRI Scans on SJM device implanted subjects for clinical purpose	Subjects who need a non-thoracic clinically indicated scan Implantable Cardioverter Defibrillatoror (ICD) or a Cardiac Re-synchronization Therapy -Defibrillator (CRT-D) device: MRI Scans on SJM device implanted subjects for clinical purpose
Period Title: Overall Study
STARTED	132	57
COMPLETED	131	57
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Pacemaker, ICD, or CRT Device Patients
Arm/Group Description	Subjects who need a non-thoracic clinically indicated scan Pacemaker, ICD, or CRT device: MRI Scans on SJM device implanted subjects for clinical purpose
Overall Participants	189
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70.7 (12.0)
Sex: Female, Male (Count of Participants)
Female	63 33.3%
Male	126 66.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	10 5.3%
Not Hispanic or Latino	179 94.7%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	2 1.1%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	12 6.3%
White	174 92.1%
More than one race	0 0%
Unknown or Not Reported	1 0.5%
Region of Enrollment (participants) [Number]
United States	189 100%
Arrhythmia History (Count of Participants)
Atrial Arrhythmia	94 49.7%
Ventricular Arrhythmia	26 13.8%
No Arrhythmia History	69 36.5%

Outcome Measures

1. Primary Outcome

Title	The Proportion of MRI Scans From Pacemakers or CRT-Ps Providing Sufficient Image Quality to Allow for a Diagnostic Interpretation.
Description	Based on the ability of the radiologist to read and provide a diagnosis/report.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

Proportion of MRI scans from CRT-Ps or Pacemakers providing sufficient image quality for diagnostic interpretation

Arm/Group Title	Pacemaker or CRT-P Device Patients
Arm/Group Description	Subjects who need a non-thoracic clinically indicated scan Pacemaker or Cardiac Re-synchronization Therapy -Pacemaker (CRT-P) device: MRI Scans on SJM device implanted subjects for clinical purpose
Measure Participants	131
Measure MRI Scans	131
Count of Units [MRI Scans]	129

2. Primary Outcome

Title	The Proportion of MRI Scans From ICDs or CRT-Ds Providing Sufficient Image Quality to Allow for a Diagnostic Interpretation.
Description	Based on the ability of the radiologist to read and provide a diagnosis/report.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

Proportion of MRI scans from ICDs or CRT-Ds providing sufficient image quality for diagnostic interpretation

Arm/Group Title	ICD or CRT-D Device Patients
Arm/Group Description	Subjects who need a non-thoracic clinically indicated scan Implantable Cardioverter Defibrillator or (ICD) or a Cardiac Re-synchronization Therapy -Defibrillator (CRT-D) device: MRI Scans on SJM device implanted subjects for clinical purpose
Measure Participants	57
Measure MRI Scans	57
Count of Units [MRI Scans]	56

Adverse Events

Time Frame	Adverse events were collected from study enrollment until 1 month after the MRI scan was performed.
Adverse Event Reporting Description	A Clinical Events Committee (CEC) composed of physicians who were not actively involved as investigators in any of the studies under the committee's review, nor may they have any significant financial interest in the technology under study, reviewed and adjudicated all adverse device effects, whether serious or not, and all deaths that were reported during the study.
Arm/Group Title	Pacemaker, ICD, or CRT Device Patients
Arm/Group Description	Subjects who need a non-thoracic clinically indicated scan Pacemaker, ICD, or CRT device: MRI Scans on SJM device implanted subjects for clinical purpose
All Cause Mortality
	Pacemaker, ICD, or CRT Device Patients
	Affected / at Risk (%)	# Events
Total	1/189 (0.5%)
Serious Adverse Events
	Pacemaker, ICD, or CRT Device Patients
	Affected / at Risk (%)	# Events
Total	0/189 (0%)
Other (Not Including Serious) Adverse Events
	Pacemaker, ICD, or CRT Device Patients
	Affected / at Risk (%)	# Events
Total	4/189 (2.1%)
Cardiac disorders
Back-Up Operation	1/189 (0.5%)	1
General disorders
Chest Pain/ Discomfort	2/189 (1.1%)	2
Infections and infestations
Respiratory Infection	1/189 (0.5%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.