Safety of MR (Magnetic Resonance)-Conditional ICDsNCT02506569
ProMRI 3T ENHANCED Master Study
An observational study of Safety of MR (Magnetic Resonance)-Conditional ICDs, run by Biotronik SE & Co. KG at 12 sites in 5 countries.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Safety of MR (Magnetic Resonance)-Conditional ICDs
- What is being tested?
- Implantable Cardioverter Defibrillator therapy and Magnetic Resonance Imaging (MRI)
- Type of treatment
- Medical device
- How many people
- 129 participants
- Where
- 12 sitesin 5 countries
- Study dates
- Jan 2015to 15 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients selected for participation should be from the investigator's general patient population according to the inclusion and exclusion criteria.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
12 sites in 5 countries.
12 sites in 5 countries
Germany5 sites
Deutsches Herzzentrum Berlin
Berlin
Klinikum Coburg
Coburg
Uniklinikum Düsseldorf
Düsseldorf
Universitätsklinikum Göttingen
Göttingen
St. Bonifatius Hospital
Lingen
Australia3 sites
Flinders Medical Centre
Bedford Park
Royal North Shore Hospital
Sydney
Westmead Hospital
Westmead
Austria2 sites
Allgemeines Krankenhaus Linz
Linz
Landesklinikum St. Pölten
Sankt Pölten
About this study
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 .
- Being tested
- Implantable Cardioverter Defibrillator therapy, Magnetic Resonance Imaging (MRI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable Cardioverter Defibrillator therapyDevice
Tachycardia Fast Heart Beat
Magnetic Resonance Imaging (MRI)Other
MRI scan of the head and lower body parts
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Device Effect (SADE)-free rate of implantable cardioverter defibrillators and leads possibly or securely related to the MRI procedure
Measured: 1 Month
Increase in pacing thresholds ratios measured between 1-month post-MRI and pre-MRI
Evaluate the percentage of ICD leads with an increase in the pacing threshold ratio measured between the Pre-MRI and 1-month post-MRI
Measured: 1 Month
Decrease in sensing amplitude ratios between 1-month post-MRI and pre-MRI
Evaluate the percentage of ICD leads with a decrease in the sensing amplitude ratio measured between the Pre-MRI and 1-month post-MRI
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study startJan 2015
- Primary completion15 Jan 2018
- Study completion15 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety of MR (Magnetic Resonance)-Conditional ICDsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rainer Zbinden, Dr., Principal investigator, Triemli Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02506569
- Sponsor's protocol ID
- TA109
- Status last verified
- Feb 2018
- First submitted
- 14 Jul 2015
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ProMRI 3T ENHANCED Master Study
- ClinicalTrials.gov ID
- NCT02506569
- Acronym / sponsor ID
- TA109
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- 15 Jan 2018 (actual)
- First posted
- 23 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients selected for participation should be from the investigator's general patient population according to the inclusion and exclusion criteria.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantable Cardioverter Defibrillator therapyTachycardia Fast Heart Beat | Device | – |
| Magnetic Resonance Imaging (MRI)MRI scan of the head and lower body parts | Other | – |
Primary outcome
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
Increase in pacing thresholds ratios measured between 1-month post-MRI and pre-MRI
Time frame: 1 Month
Evaluate the percentage of ICD leads with an increase in the pacing threshold ratio measured between the Pre-MRI and 1-month post-MRI
Decrease in sensing amplitude ratios between 1-month post-MRI and pre-MRI
Time frame: 1 Month
Evaluate the percentage of ICD leads with a decrease in the sensing amplitude ratio measured between the Pre-MRI and 1-month post-MRI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rainer Zbinden, Dr. principal investigator
Triemli Hospital
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Safety of MR (Magnetic Resonance)-Conditional ICDs, run by Biotronik SE & Co. KG at 12 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany, Australia, Austria, Singapore, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2018; AzTrials last refreshed its copy on 5 Nov 2026.