ProMRI AFFIRM Study of the EVIA/ENTOVIS Pacemaker With Safio S Pacemaker Leads
NCT ID: NCT01460992
Last Updated: 2013-11-28
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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COMPLETED
121 participants
OBSERVATIONAL
2012-03-31
2013-11-30
Brief Summary
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Detailed Description
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The specific MRI conditions for this investigation with the EVIA/ENTOVIS pacemaker family and Safio S pacemaker leads are defined in the study protocol
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Pacemaker therapy
Patients with an EVIA/ ENTOVIS pacemaker device. See inclusion and exclusion criteria.
Evia/Entovis pacemaker system under Magnetic Resonance Imaging (MRI) conditions
patients will undergo an MRI scan for 30 minutes.
Interventions
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Evia/Entovis pacemaker system under Magnetic Resonance Imaging (MRI) conditions
patients will undergo an MRI scan for 30 minutes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The pacemaker system has to be implanted, repositioned or exchanged at least 5 weeks prior to enrollment
* Age more than 18 years
* Understand the nature of the procedure
* Able and willing to complete MRI testing
* Able and willing to activate and use the Cardio Messenger
* Give written informed consent
* Able to complete all testing required by the clinical protocol
* Ability to measure atrial and/or ventricular pacing threshold(s)\* (at 0.4 ms)
* All pacing thresholds do not exceed 2.0V @0.4ms.
* Available for follow-up visit at the investigational site
* Patient body height greater or equal to 140 cm
* Pectoral implantation
* The ascertained lead impedance is between 200 and 1500 Ohms.
Exclusion Criteria
* Pacing threshold(s) (at 0.4 ms) and sensing amplitudes are not measurable
* Meet one or more of the contraindications
* Being pregnant
* Have a life expectancy of less than three months
* Cardiac surgery already scheduled in the next three months
* Enrolled in another cardiac clinical investigation
* Have other medical implants that may interact with MRI, e.g. abandoned pacemaker/ICD leads, lead extensions, other active medical devices, non-MRI compatible devices (e.g. mechanical tricuspid valve)
* Have other metallic artifacts/components in body that may interact with MRI
18 Years
ALL
No
Sponsors
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Biotronik SE & Co. KG
INDUSTRY
Responsible Party
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Principal Investigators
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Aldo Rinaldi, Dr.
Role: PRINCIPAL_INVESTIGATOR
Cardiology Department, St Thomas' Hospital Lambeth Palace Road London, SE1 7EH United Kingdom E-mail: [email protected]
Locations
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Allgemeines Krankenhaus Linz
Linz, , Austria
University Hospital Olomouc
Olomouc, , Czechia
St. Gertrauden Krankenhaus
Berlin, , Germany
Städtisches Klinikum Dresden-Friedrichstadt
Dresden, , Germany
Uniklinik Leipzig
Leipzig, , Germany
Diakoniekrankenhaus Mannheim
Mannheim, , Germany
DRK Krankenhaus Neuwied
Neuwied, , Germany
Stadtspital Triemli
Zurich, , Switzerland
Cardiology Department, St Thomas' Hospital
London, , United Kingdom
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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49
Identifier Type: -
Identifier Source: org_study_id