ProMRI 3T ENHANCED Master Study

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02506569
• Date of registration: 14/07/2015
• Prospective Registration: No
• Primary sponsor: Biotronik SE & Co. KG
• Public title: ProMRI 3T ENHANCED Master Study
• Scientific title: ProMRI 3T ENHANCED Master Study
• Date of first enrolment: January 2015
• Target sample size: 129
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02506569
• Study type: Observational

Countries of recruitment

Australia, Austria, France, Germany, Singapore, Switzerland

Contacts

• Name: Rainer Zbinden, Dr.
• Affiliation: Triemli Hospital

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Safety of MR (Magnetic Resonance)-Conditional ICDs

Intervention(s)

Other: Magnetic Resonance Imaging (MRI)

Device: Implantable Cardioverter Defibrillator therapy

Primary Outcome(s)

Increase in pacing thresholds ratios measured between 1-month post-MRI and pre-MRI [Time Frame: 1 Month]

Decrease in sensing amplitude ratios between 1-month post-MRI and pre-MRI [Time Frame: 1 Month]

Serious Adverse Device Effect (SADE)-free rate of implantable cardioverter defibrillators and leads possibly or securely related to the MRI procedure [Time Frame: 1 Month]

Secondary ID(s)

TA109

Source(s) of Monetary Support

Please refer to primary and secondary sponsors