ProMRI AFFIRM Study of the EVIA/ENTOVIS Pacemaker With Safio S Pacemaker Leads (ProMRIAFFIRM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01460992|
Recruitment Status : Completed
First Posted : October 27, 2011
Last Update Posted : November 28, 2013
|Condition or disease||Intervention/treatment|
|Cardiac Disease||Procedure: Evia/Entovis pacemaker system under Magnetic Resonance Imaging (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|
|Actual Enrollment :||121 participants|
|Official Title:||Master Study for the MRI Compatibility of the EVIA/ENTOVIS Pacemaker in Combination With Safio S Pacemaker Lead|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||November 2013|
Patients with an EVIA/ ENTOVIS pacemaker device. See inclusion and exclusion criteria.
Procedure: Evia/Entovis pacemaker system under Magnetic Resonance Imaging (MRI) conditions
patients will undergo an MRI scan for 30 minutes.
- Primary hypothesis 1: MRI and pacing system related Serious Adverse Device Effect (SADE) free rate [ Time Frame: 3 months ]MRI and pacing system related Serious Adverse Device Effect (SADE) Free-Rate is greater than 90%.
- Primary hypotheses 2 and 3: pacing threshold rise (atrial and ventricular) [ Time Frame: 1 month ]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
- Primary hypothesis 4: P-wave sensing attenuation [ Time Frame: 1 month ]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
- Primary hypothesis 5: R-wave sensing attenuation [ Time Frame: 1 month ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460992
|Allgemeines Krankenhaus Linz|
|Linz, Austria, 4021|
|University Hospital Olomouc|
|Olomouc, Czech Republic|
|St. Gertrauden Krankenhaus|
|Städtisches Klinikum Dresden-Friedrichstadt|
|DRK Krankenhaus Neuwied|
|Cardiology Department, St Thomas' Hospital|
|London, United Kingdom, SE1 7EH|
|Principal Investigator:||Aldo Rinaldi, Dr.||Cardiology Department, St Thomas' Hospital Lambeth Palace Road London, SE1 7EH United Kingdom E-mail: Aldo.Rinaldi@gstt.nhs.uk|