Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
1768 participants
OBSERVATIONAL
2017-06-08
2020-06-30
Brief Summary
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Detailed Description
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Additionally, the study will assess the safety of the pacemaker system in subject(s) undergoing clinically indicated MRI scan(s). Any enrolled subject implanted with the SJM Brady MRI system may be included in this evaluation if they are scheduled for or planning to have a MRI scan during the course of the study.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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St. Jude Medical Tendril MRI™ lead
pacemaker, leads
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject is at least 18 years of age or of legal age to give informed consent specific to state and national law.
3. Subject meets at least one of the following criteria:
1. Is an Accent MRI IDE study subject who is being rolled over into the SJM Brady MRI PAS and still has at least one Tendril MRI™ lead implanted with a SJM Brady MRI pacemaker such as the Accent MRI or similar model.
2. Is a subject who has been implanted with at least one Tendril MRI lead and a SJM Brady MRI pacemaker such as the Accent MRI or similar model, but is not part of the Accent MRI IDE study and will be enrolled within 30 days after implant.
3. Is a subject who will be implanted with at least one Tendril MRI lead and a SJM Brady MRI pacemaker such as the Accent MRI or similar model and will be consented either at or within 30 days before implant.
4. Subject is willing and able to comply with the prescribed follow-up tests and schedule of evaluations including MRI scan procedures.
Exclusion Criteria
2. Subject is not expected to be able to complete the study follow up schedule or duration due to any health condition such as has malignancy, is deemed a candidate for transplant or Ventricular Assist Device, or in hospice care.
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Grant Kim, MS
Role: STUDY_DIRECTOR
Abbott (formerly St. Jude Medical)
Locations
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Phoenix Cardiovascular Research Group
Phoenix, Arizona, United States
Cardiology Associates of North East Arkansas
Jonesboro, Arkansas, United States
Arkansas Heart Hospital
Little Rock, Arkansas, United States
Mercy Hospital Northwest Arkansas
Rogers, Arkansas, United States
Central Cardiology
Bakersfield, California, United States
Raymond Schaerf, MD
Burbank, California, United States
St. Helena Hospital
Deer Park, California, United States
USC University Hospital
Los Angeles, California, United States
Riverside Medical Clinic
Riverside, California, United States
Sutter Medical Center, Sacramento
Sacramento, California, United States
San Diego Heart Rhythm Center
San Diego, California, United States
University of California at San Diego (UCSD) Medical Center
San Diego, California, United States
Medical Specialists of the Palm Beaches
Atlantis, Florida, United States
Bay Area Cardiology Associates PA
Brandon, Florida, United States
Shands Jacksonville
Jacksonville, Florida, United States
Hrachian Hakop MD PA
South Miami, Florida, United States
Cardiology Partners
Wellington, Florida, United States
Piedmont Athens Regional Medical Center
Athens, Georgia, United States
Atlanta Heart Specialist
Cumming, Georgia, United States
Coliseum Medical Centers
Macon, Georgia, United States
University of Kentucky
Lexington, Kentucky, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
McLaren Health Care Corporation
Auburn Hills, Michigan, United States
Sparrow Clinical Research Institute
Lansing, Michigan, United States
MidMichigan Medical Center-Midland
Midland, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
Jackson Heart Clinic
Jackson, Mississippi, United States
Missouri Heart Center
Columbia, Missouri, United States
St. Luke's Hospital
Kansas City, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Kearney Regional Medical Center
Kearney, Nebraska, United States
BryanLGH Medical Center East
Lincoln, Nebraska, United States
Cardiovascular Associates of the Delaware Valley
Haddon Heights, New Jersey, United States
Saint Barnabas Medical Center
Livingston, New Jersey, United States
New Brunswick Cardiology Group
Somerset, New Jersey, United States
New Mexico Heart Institute
Albuquerque, New Mexico, United States
Capital Cardiology Associates
Albany, New York, United States
New York Presbyterian Hospital/Cornell University
New York, New York, United States
Hudson Valley Cardiovascular Practice, P.C.
Poughkeepsie, New York, United States
Novant Health Heart and Vascular Research Institute
Charlotte, North Carolina, United States
East Carolina Heart Institute
Greenville, North Carolina, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
The Toledo Hospital
Toledo, Ohio, United States
Abington Medical Specialists
Abington, Pennsylvania, United States
Pinnacle Health System
Harrisburg, Pennsylvania, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Donald Guthrie Foundation for Education and Research
Sayre, Pennsylvania, United States
Trident Medical Center
Charleston, South Carolina, United States
St. Francis Hospital
Greenville, South Carolina, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Erlanger Medical Center
Chattanooga, Tennessee, United States
The Stern Cardiovascular Foundation
Germantown, Tennessee, United States
BCS Heart, LLP
College Station, Texas, United States
Medical City Dallas Hospital
Dallas, Texas, United States
Fort Worth Heart
Fort Worth, Texas, United States
Houston Cardiovascular Associates
Houston, Texas, United States
South Texas Cardiovascular Consultants
San Antonio, Texas, United States
Carient Heart & Vascular, P.C.
Manassas, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Aurora Medical Group
Milwaukee, Wisconsin, United States
Aspirus Wausau Hospital
Wausau, Wisconsin, United States
Cheyenne Cardiology Associates
Cheyenne, Wyoming, United States
Countries
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Other Identifiers
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SJM-CIP- CL1000304
Identifier Type: -
Identifier Source: org_study_id
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