Clinical trial NCT02506569: ProMRI 3T ENHANCED Master Study
Official title: ProMRI 3T ENHANCED Master Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Safety of MR (Magnetic Resonance)-Conditional ICDs
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2015-07-23
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients selected for participation should be from the investigator's general patient population according to the inclusion and exclusion criteria.

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 .


Eligibility 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

Primary outcomes:
measure: Serious Adverse Device Effect (SADE)-free rate of implantable cardioverter defibrillators and leads possibly or securely related to the MRI procedure
timeFrame: 1 Month
measure: Increase in pacing thresholds ratios measured between 1-month post-MRI and pre-MRI
timeFrame: 1 Month
measure: Decrease in sensing amplitude ratios between 1-month post-MRI and pre-MRI
timeFrame: 1 Month
Secondary outcomes:
Other outcomes:
Locations:
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
city: Sydney
country: Australia
facility: Royal North Shore Hospital
city: Westmead
country: Australia
facility: Westmead Hospital
city: Linz
country: Austria
facility: Allgemeines Krankenhaus Linz
city: St. Pölten
country: Austria
facility: Landesklinikum St. Pölten
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Coburg
country: Germany
facility: Klinikum Coburg
city: Düsseldorf
country: Germany
facility: Uniklinikum Düsseldorf
city: Göttingen
country: Germany
facility: Universitätsklinikum Göttingen
city: Lingen
country: Germany
facility: St. Bonifatius Hospital
city: Singapore
country: Singapore
facility: National Heart Centre
city: Zürich
country: Switzerland
facility: Stadtspital Triemli
Study officials:
affiliation: Triemli Hospital
name: Rainer Zbinden, Dr.
role: PRINCIPAL_INVESTIGATOR
References: