This investigation is designed to demonstrate the clinical safety of the EVIA/ ENTOVIS pacemaker system when used under specific MRI conditions.
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/ENTOVIS pacemakers in combination with the Safio S pacemaker leads, scheduled to be part of this clinical study. The specific MRI conditions for this investigation with the EVIA/ENTOVIS pacemaker family and Safio S pacemaker leads are defined in the study protocol
Study Type
OBSERVATIONAL
Enrollment
121
patients will undergo an MRI scan for 30 minutes.
Allgemeines Krankenhaus Linz
Linz, Austria
University Hospital Olomouc
Olomouc, Czechia
St. Gertrauden Krankenhaus
Berlin, Germany
Städtisches Klinikum Dresden-Friedrichstadt
Dresden, Germany
Primary hypothesis 1: MRI and pacing system related Serious Adverse Device Effect (SADE) free rate
MRI and pacing system related Serious Adverse Device Effect (SADE) Free-Rate is greater than 90%.
Time frame: 3 months
Primary hypotheses 2 and 3: pacing threshold rise (atrial and ventricular)
The atrial or ventricular MRI induced pacing threshold rise is not larger than or equal to 0.5 V between Pre-MRI and 1-month follow-up
Time frame: 1 month
Primary hypothesis 4: P-wave sensing attenuation
P-wave attenuation: P-wave amplitude decrease (between pre-MRI follow-up and 1-month follow-up) exceeding 50% or a P-wave amplitude at 1-month follow-up smaller or equal to 1.5 mV
Time frame: 1 month
Primary hypothesis 5: R-wave sensing attenuation
R-wave attenuation: R-wave amplitude decrease (between pre-MRI follow-up and 1-month follow-up) exceeding 50% or a R-wave amplitude at 1-month follow-up smaller or equal to 5.0 mV.
Time frame: 1 month
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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