Completed
Master Study for the MRI Compatibility of the Solia S and Solia T Pacing Lead, the Linoxsmart ProMRI and Linoxsmart ProMRI DF4 ICD (Implantable Cardioverter-defibrillator) Lead and the Corox ProMRI OTW Coronary Sinus Lead in Combination With the Ilesto/Iforia ICD or the Evia/Entovis Triple Chamber Pacemaker
What is being collected
Device Data
+ other Data
Collected from today forward - ProspectiveDeviceOther
Who is being recruted
Over 18 Years
+17 Eligibility Criteria
How is the trial designed
Case-Only
Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.Observational
Study Start: June 2013
Summary
Principal SponsorBiotronik SE & Co. KG
Last updated: March 2, 2016
Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 2013
Actual date on which the first participant was enrolled.This investigation is designed to provide supporting evidence for the clinical safety of the Ilesto/Iforia ICD (implantable cardioverter-defibrillator)system and the Evia/Entovis HF-T (Heart Failure) triple chamber pacemaker system when used under specific MRI (magnetic resonance imaging) conditions.
Principal SponsorBiotronik SE & Co. KG
Last updated: March 2, 2016
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
174 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-only
These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
9 inclusion criteria required to participate
Able and willing to activate and use the Cardio Messenger
Able and willing to complete MRI testing
Able and willing to complete all testing required by the clinical protocol
Age >= 18 years
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8 exclusion criteria prevent from participating
Cardiac surgery in the next eight months
Enrolled in another non-observational cardiac clinical investigation
Life expectancy of less than eight months
Patient has other medical implants that may interact with MRI, e.g. abandoned pacemaker/ICD leads, lead extensions, mechanical valves, other active medical devices, non-MRI compatible devices
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 23 locations
Flinders Medical Center
Bedford Park, AustraliaBox Hill Hospital
Box Hill, AustraliaRoyal Adelaide Hospital
Adelaide, AustraliaCompleted23 Study Centers