Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
221 participants
OBSERVATIONAL
2013-12-31
2015-01-31
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 heart/chest or thoracic spine.
Interventions
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Patients with a ProMRI Pacemaker System
Bradycardia Slow Heart Beat
Magnetic Resonance Imaging (MRI) scan
MRI scan of heart/chest or thoracic spine.
Eligibility Criteria
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Inclusion Criteria
* 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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Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Concord, California, United States
Newport Beach, California, United States
Rancho Mirage, California, United States
New Haven, Connecticut, United States
Newark, Delaware, United States
Washington D.C., District of Columbia, United States
Valparaiso, Indiana, United States
Iowa City, Iowa, United States
Lafayette, Louisiana, United States
Cumberland, Maryland, United States
Boston, Massachusetts, United States
Burlington, Massachusetts, United States
Worcester, Massachusetts, United States
Ann Arbor, Michigan, United States
Ypsilanti, Michigan, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Flushing, New York, United States
New York, New York, United States
The Bronx, New York, United States
Winston-Salem, North Carolina, United States
Toledo, Ohio, United States
Salem, Oregon, United States
Newtown, Pennsylvania, United States
Greenville, South Carolina, United States
Greenville, South Carolina, United States
Amarillo, Texas, United States
Mechanicsville, Virginia, United States
Virginia Beach, Virginia, United States
Spokane, Washington, United States
Countries
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References
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Bailey WM, Mazur A, McCotter C, Woodard PK, Rosenthal L, Johnson W, Mela T; ProMRI Study Investigators. Clinical safety of the ProMRI pacemaker system in patients subjected to thoracic spine and cardiac 1.5-T magnetic resonance imaging scanning conditions. Heart Rhythm. 2016 Feb;13(2):464-71. doi: 10.1016/j.hrthm.2015.09.021. Epub 2015 Sep 25.
Other Identifiers
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G120226 (Phase B)
Identifier Type: -
Identifier Source: org_study_id