Status:
COMPLETED
ProMRI AFFIRM Study of the EVIA/ENTOVIS Pacemaker With Safio S Pacemaker Leads
Lead Sponsor:
Biotronik SE & Co. KG
Conditions:
Cardiac Disease
Eligibility:
All Genders
18+ years
Brief Summary
This investigation is designed to demonstrate the clinical safety of the EVIA/ ENTOVIS pacemaker system when used under specific MRI conditions.
Detailed Description
In the past, MR scans were always contraindicated for pacemaker patients. If particular prerequisites and conditions are fulfilled, MR scans can now be conducted on patients with BIOTRONIK's EVIA/ENTO...
Eligibility Criteria
Inclusion
- Pacemaker system consisting solely of the EVIA/ENTOVIS pacemaker and Safio S pacemaker leads
- 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
- No EVIA/ENTOVIS /Safio S pacemaker system implanted
- 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
Key Trial Info
Start Date :
March 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT01460992
Start Date
March 1 2012
End Date
November 1 2013
Last Update
November 28 2013
Active Locations (9)
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1
Allgemeines Krankenhaus Linz
Linz, Austria, 4021
2
University Hospital Olomouc
Olomouc, Czechia
3
St. Gertrauden Krankenhaus
Berlin, Germany
4
Städtisches Klinikum Dresden-Friedrichstadt
Dresden, Germany