Study Results
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View full resultsBasic Information
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COMPLETED
229 participants
OBSERVATIONAL
2013-02-28
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Pacemaker Therapy
Patients with a ProMRI Pacemaker System
Patients with a ProMRI Pacemaker System
Bradycardia Slow Heart Beat
Magnetic Resonance Imaging (MRI) scan
MRI scan of head and lower back.
Interventions
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Patients with a ProMRI Pacemaker System
Bradycardia Slow Heart Beat
Magnetic Resonance Imaging (MRI) scan
MRI scan of head and lower back.
Eligibility Criteria
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Inclusion Criteria
* Subject body height greater than 140 cm (4' 7")
* Able and willing to complete MRI testing
* Able to provide written informed consent
* Available for follow-up visit at the study site
* Implanted with a pacemaker system consisting only of an Entovis pacemaker (DR-T, SR-T) and one or two Setrox S 53 or Setrox S 60 pacemaker lead(s). (No leads other than Setrox S (53 or 60 cm) leads may be implanted. This includes lead extensions or abandoned leads in the subject.)
* Pacemaker implanted pectorally
* All pacemaker system components implanted, repositioned, or exchanged at least 5 weeks prior to enrollment
* Underling rhythm identifiable during sensing test
* All pacing thresholds are measureable and are less than or equal to 2.0 V @0.4 ms
* Absence of phrenic nerve stimulation at 4.8V @ 1.0 ms
* Pacing impedance is between 200 and 1500 ohm
* Able and willing to use the Cardio Messenger
At the pre-MRI procedure, the following procedure-related criteria must be met for the subject to undergo the MRI scan:
* Absence of phrenic nerve stimulation at 4.8V @ 1.0 ms
* \|pacing threshold at Pre-MRI follow-up - pacing threshold at baseline\| ≤ 0.5 V
* All pacing thresholds are measureable and are ≤ 2.0 V @ 0.4 ms
* The pacemaker system has been implanted for at least 6 weeks.
* Subject did not have a pacemaker or lead explant, exchange or reposition in the previous 6 weeks.
* All lead impedances are between 200 and 1500 ohm.
* Battery status is at least 30% of capacity
Exclusion Criteria
* For pacemaker systems that include an atrial lead, subjects with either
* Persistent atrial arrhythmia (lasting longer than 7 days or requiring cardioversion)
* Permanent atrial arrhythmia
* Life expectancy of less than three months
* Pregnancy
* Cardiac surgery expected in the next three months
* Implanted with other medical devices that may interact with MRI, such as:
* abandoned pacemaker/ICD leads
* lead extensions
* mechanical valves
* other active medical devices
* non-MRI compatible devices
* other metallic artifacts/components in body that may interact with MRI
18 Years
ALL
No
Sponsors
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Biotronik, Inc.
INDUSTRY
Responsible Party
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Locations
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Arizona Arrhythmia Consultants
Scottsdale, Arizona, United States
John Muir Medical Center
Concord, California, United States
Hoag Hospital
Newport Beach, California, United States
Eisenhower Medical Center
Rancho Mirage, California, United States
Yale - New Haven Hospital
New Haven, Connecticut, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Valparaiso, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Louisiana Heart Rhythm Specialists
Lafayette, Louisiana, United States
Cumberland, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Burlington, Massachusetts, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Saint Joseph Mercy Medical Center
Ypsilanti, Michigan, United States
Research Medical Center
Kansas City, Missouri, United States
Washington University
St Louis, Missouri, United States
Camden, New Jersey, United States
New York Hospital Queens
Flushing, New York, United States
New York, New York, United States
Winston-Salem, North Carolina, United States
Toledo Hospital
Toledo, Ohio, United States
Saint Mary Medical Center
Langhorne, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Greenville, South Carolina, United States
Richmond, Virginia, United States
Countries
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References
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Bailey WM, Rosenthal L, Fananapazir L, Gleva M, Mazur A, Rinaldi CA, Kypta A, Merkely B, Woodard PK; ProMRI/ProMRI AFFIRM Study Investigators. Clinical safety of the ProMRI pacemaker system in patients subjected to head and lower lumbar 1.5-T magnetic resonance imaging scanning conditions. Heart Rhythm. 2015 Jun;12(6):1183-91. doi: 10.1016/j.hrthm.2015.02.010. Epub 2015 Feb 11.
Other Identifiers
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G120226
Identifier Type: -
Identifier Source: org_study_id
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