ProMRI 3T ENHANCED Master Study

Biotronik

Status: Completed

Conditions: Safety of MR (Magnetic Resonance)-Conditional ICDs

Treatments: Device: Implantable Cardioverter Defibrillator therapy; Other: Magnetic Resonance Imaging (MRI)

Study type: Observational

Funder types: Industry

Identifiers

NCT02506569

TA109

Details and patient eligibility

About

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 .

Enrollment: 129 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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