SJM MRI Diagnostic Imaging Registry (IDE)

Cardiac Arrhythmia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02807948
• Other study ID #: SJM-CIP-10130
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: January 31, 2018

Study information

• Verified date: August 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: January 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia

Intervention

Device:
• Pacemaker, ICD, or CRT device
MRI Scans on SJM device implanted subjects for clinical purpose

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month
Primary	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.	1 month