Safety of MR (Magnetic Resonance) Conditional CRT-pacemakers and ICDs
Conditions
Keywords
ICD therapy, CRT-P therapy, MRI
Brief summary
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.
Interventions
DEVICEICD/CRT-P therapy
OTHERMRI
Sponsors
Biotronik SE & Co. KG
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent * Able and willing to complete MRI testing * Able and willing to activate and use the Cardio Messenger * Able and willing to complete all testing required by the clinical protocol * Available for all follow-up visits at the investigational site * Standard indication for single, dual, or triple chamber ICD or CRT-P. * ICD or CRT-P system to be implanted in the pectoral region * Patient body height ≥ 140 cm * Age ≥ 18 years
Exclusion criteria
* Standard contraindication for single, dual, or triple chamber ICD or CRT-P. * Systems with an atrial lead: The patient has persistent (lasting longer than 7 days or requiring cardioversion) or permanent atrial arrhythmia * 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 * Patient has other metallic artifacts / components in body that may interact with MRI * Life expectancy of less than eight months * Cardiac surgery in the next eight months * Pregnant or breastfeeding * Enrolled in another non-observational cardiac clinical investigation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Serious Adverse Device Effect (SADE) -free rate of the ICD/CRT-P system related to MRI | pre-MRI: approx. 2 to 5 months after implantation; post-MRI: 1 month (-2/+4 weeks) after MRI |
| Increase in atrial and ventricular pacing threshold(s) between pre-MRI and 1-month post-MRI | pre-MRI: approx. 2 to 5 months after implantation; post-MRI: 1 month (-2/+4 weeks) after MRI |
| Decrease in P-wave and R-wave amplitude (right and left) between pre-MRI and 1-month post-MRI. | pre-MRI: approx. 2 to 5 months after implantation; post-MRI: 1 month (-2/+4 weeks) after MRI |
Countries
Australia, Austria, Canada, Czechia, France, Germany, Hungary, Switzerland
Outcome results
None listed