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/ct2/show/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
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 .
Trial website
https://clinicaltrials.gov/ct2/show/NCT02506569
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02506569