Clinical trial NCT02807948: SJM MRI Diagnostic Imaging Registry (IDE)
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrhythmia
Keywords: MRI Scan, pacemakers, ICD, CRT
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2016-06-21
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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
8. Patient has a lead extender, adaptor, or capped/abandoned lead
9. Patient is pregnant

Primary outcomes:
measure: The Proportion of MRI Scans From Pacemakers or CRT-Ps Providing Sufficient Image Quality to Allow for a Diagnostic Interpretation.
timeFrame: 1 month
measure: The Proportion of MRI Scans From ICDs or CRT-Ds Providing Sufficient Image Quality to Allow for a Diagnostic Interpretation.
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale Medical Imaging
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Jonesboro
country: United States
facility: St. Bernards
state: Arkansas
city: Bakersfield
country: United States
facility: Quest Imaging
state: California
city: Burbank
country: United States
facility: Raymond Schaerf, MD
state: California
city: Concord
country: United States
facility: John Muir Medical Center
state: California
city: Deer Park
country: United States
facility: St. Helena Hospital
state: California
city: Fresno
country: United States
facility: Cardiovascular Consultants Heart Center
state: California
city: Newport Beach
country: United States
facility: Newport Diagnostic Center
state: California
city: North Hollywood
country: United States
facility: Pro Health Advance Imaging
state: California
city: Rancho Mirage
country: United States
facility: Eisenhower Medical Center
state: California
city: San Francisco
country: United States
facility: St. Mary's Medical Center
state: California
city: Santa Barbara
country: United States
facility: Sansum Clinic - Santa Barbara Medical Foundation
state: California
city: Littleton
country: United States
facility: South Denver Cardiology Associates PC
state: Colorado
city: Loveland
country: United States
facility: Medical Center of the Rockies
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
city: Boca Raton
country: United States
facility: Cardiac Arrhythmia Services
state: Florida
city: Jupiter
country: United States
facility: Jupiter Medical Center
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Athens
country: United States
facility: Piedmont Athens Regional Medical Center
state: Georgia
city: Park Ridge
country: United States
facility: Advocate Lutheran General Hospital
state: Illinois
city: Springfield
country: United States
facility: Prairie Education and Research Cooperative
state: Illinois
city: Indianapolis
country: United States
facility: Community Heart and Vascular
state: Indiana
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Ashland
country: United States
facility: King's Daughters Medical Center
state: Kentucky
city: Shreveport
country: United States
facility: LSU Health Sciences Center
state: Louisiana
city: Bethesda
country: United States
facility: Suburban Hospital
state: Maryland
city: Takoma Park
country: United States
facility: Washington Adventist Hospital
state: Maryland
city: Auburn Hills
country: United States
facility: McLaren Health Care Corporation
state: Michigan
city: Jackson
country: United States
facility: Baptist Medical Center
state: Mississippi
city: Columbia
country: United States
facility: Advanced Radiology
state: Missouri
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital St. Louis
state: Missouri
city: Kearney
country: United States
facility: Kearney Regional Medical Center
state: Nebraska
city: Denville
country: United States
facility: Denville Diagnostics and Open MRI LLC
state: New Jersey
city: Rochester
country: United States
facility: Borg and Ide Imaging
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Winston-Salem
country: United States
facility: Novant Clinical Research Institute
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Corvallis
country: United States
facility: Samaritan Heart & Vascular Institute - Cardiology Dept.
state: Oregon
city: Eugene
country: United States
facility: Oregon Medical Group
state: Oregon
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Hospital - 17th Street
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Langhorne
country: United States
facility: St. Mary Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Singer Research Institute
state: Pennsylvania
city: Sayre
country: United States
facility: Donald Guthrie Foundation for Education and Research
state: Pennsylvania
city: Charleston
country: United States
facility: Trident Medical Center
state: South Carolina
city: Chattanooga
country: United States
facility: Erlanger Medical Center
state: Tennessee
city: Fort Worth
country: United States
facility: Baylor All Saints Medical Center at Fort Worth
state: Texas
city: Tyler
country: United States
facility: East Texas Medical Center
state: Texas
city: Lynchburg
country: United States
facility: Lynchburg General Hospital
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Bellevue
country: United States
facility: Overlake Hospital Medical Center
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center - Heart & Vascular
state: Washington
city: Milwaukee
country: United States
facility: Aurora Medical Group
state: Wisconsin
Study officials:
affiliation: Abbott Medical Devices
name: Grant Kim
role: STUDY_DIRECTOR
References: