SJM MRI Diagnostic Imaging Registry (IDE)

August 7, 2019 updated by: Abbott Medical Devices

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
189

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 month
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.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Medical Devices

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Grant Kim, Abbott Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SJM-CIP-10130

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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