Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02506569




Registration number
NCT02506569
Ethics application status
Date submitted
14/07/2015
Date registered
23/07/2015
Date last updated
7/02/2018

Titles & IDs
Public title
ProMRI 3T ENHANCED Master Study
Scientific title
ProMRI 3T ENHANCED Master Study
Secondary ID [1] 0 0
TA109
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Safety of MR (Magnetic Resonance)-Conditional ICDs 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Implantable Cardioverter Defibrillator therapy
Other interventions - Magnetic Resonance Imaging (MRI)

Treatment: Devices: Implantable Cardioverter Defibrillator therapy
Tachycardia Fast Heart Beat

Other interventions: Magnetic Resonance Imaging (MRI)
MRI scan of the head and lower body parts
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Serious Adverse Device Effect (SADE)-free rate of implantable cardioverter defibrillators and leads possibly or securely related to the MRI procedure
Timepoint [1] 0 0
1 Month
Primary outcome [2] 0 0
Increase in pacing thresholds ratios measured between 1-month post-MRI and pre-MRI
Timepoint [2] 0 0
1 Month
Primary outcome [3] 0 0
Decrease in sensing amplitude ratios between 1-month post-MRI and pre-MRI
Timepoint [3] 0 0
1 Month

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/01/2018
Sample size
Target
Accrual to date
Final
129
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
- Bedford Park
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment postcode(s) [3] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Linz
Country [2] 0 0
Austria
State/province [2] 0 0
St. Pölten
Country [3] 0 0
Germany
State/province [3] 0 0
Berlin
Country [4] 0 0
Germany
State/province [4] 0 0
Coburg
Country [5] 0 0
Germany
State/province [5] 0 0
Düsseldorf
Country [6] 0 0
Germany
State/province [6] 0 0
Göttingen
Country [7] 0 0
Germany
State/province [7] 0 0
Lingen
Country [8] 0 0
Singapore
State/province [8] 0 0
Singapore
Country [9] 0 0
Switzerland
State/province [9] 0 0
Zürich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Biotronik SE & Co. KG
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Rainer Zbinden, Dr.
Address 0 0
Triemli Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02506569