Safety of MR (Magnetic Resonance)-Conditional ICDs
Conditions
Brief summary
The investigation is designed to provide supporting evidence for the clinical safety of the Biotronik's new Implantable Cardioverter Defibrillator systems when used under specific 3 Tesla MR conditions .
Interventions
DEVICEImplantable Cardioverter Defibrillator therapy
Tachycardia Fast Heart Beat
OTHERMagnetic Resonance Imaging (MRI)
MRI scan of the head and lower body parts
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
* Implanted with Implantable Cardioverter Defibrillator (ICD) system according to Clinical Investigational Plan (CIP) * ICD system was implanted in the pectoral region * Implantation at least 5 weeks prior to enrollment date * Patient body height ≥ 140 cm * Age ≥ 18 years * Right Ventricular pacing threshold (at 0.4 ms) measurable and ≤ 2.0 V * Written informed consent * Able and willing to complete MRI testing * Able and willing to complete all testing required by the clinical protocol * Available for all follow-up visits at the investigational site
Exclusion criteria
* Standard contraindication for MRI scans * Patient shows signs of a twiddler's syndrome, i.e. fiddles with implant * Explantation, exchange or reposition of ICD or lead within 5 weeks prior to enrollment date * Charging status of the battery is Elective Replacement Indicator (ERI) or End of Service (EOS) * MRI scan within 5 weeks prior to enrollment date * R-wave sensing amplitude \< 6.5 millivolt * Lead impedance less than 200 or greater than 1500 Ohm * Life expectancy of less than six months * Cardiac surgery in the next six months * Pregnant or breastfeeding * Participation in another interventional clinical investigation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Device Effect (SADE)-free rate of implantable cardioverter defibrillators and leads possibly or securely related to the MRI procedure | 1 Month | — |
| Increase in pacing thresholds ratios measured between 1-month post-MRI and pre-MRI | 1 Month | Evaluate the percentage of ICD leads with an increase in the pacing threshold ratio measured between the Pre-MRI and 1-month post-MRI |
| Decrease in sensing amplitude ratios between 1-month post-MRI and pre-MRI | 1 Month | Evaluate the percentage of ICD leads with a decrease in the sensing amplitude ratio measured between the Pre-MRI and 1-month post-MRI |
Countries
Australia, Austria, Germany, Singapore, Switzerland
Outcome results
None listed