BradycardiaIKONENCT02175797
Assessment of the MRI Solution: KORA 100 and Beflex Pacing Leads System
A study testing MRI in people with Bradycardia, run by MicroPort CRM at 1 site in France.
Trial summary
The purpose of this study is to report the stability of atrial and ventricular leads by absence of effect of the MRI exam on the pacing and sensing threshold and to report the safety based on the serious adverse events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia
- What is being tested?
- MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Aug 2014
- Phase
- Interventional
- 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
Who may be able to join
- Patient who is already implanted with following system KORA 100 (SR or DR) pacemaker and Beflex RF45D and/or RF46D pacing leads in the left or right pectoral region
- Patient who is able and willing out-of-chest non medical indicated MRI scanning OR patients with planned medical indicated out of chest MRI scanning
- Patient who fulfils MRI solutions conditions
- Patient who provides signed and dated informed consent
Who cannot join
- Implanted or planned to be implanted non MR-compatible device or material
- Permanent Atrial Fibrillation (for DR devices)
- Diaphragmatic/phrenic stimulation
- Claustrophobia
- Incessant ventricular tachyarrhythmia
- Inability to understand the purpose of the study or refusal to co-operate
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- Unavailability for scheduled follow-ups at the implanting centre
- Already included in another clinical trial that could affect the results of this study
- Patient is minor (less than 18-years old)
- Patient is pregnant - Patient is forfeiture of freedom or under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to report the stability of atrial and ventricular leads by absence of effect of the MRI exam on the pacing and sensing threshold and to report the safety based on the serious adverse events.
- Conditions
- Bradycardia
- Being tested
- MRI
- Keywords
- Pacemaker, leads and MRI exam
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
at least 6 weeks after the implantation of the pacemaker a MRI exam is performed
| Study group | Role | What they receive |
|---|---|---|
| Pacemaker + leads | Other | all patients must have a MRI exam after pacemaker implantation Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the atrial and ventricular pacing thresholds in Volts before and after the MRI exam, using the programmer.
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 posted26 Jun 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradycardiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- MicroPort CRM
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arnaud Mr SAVOURE, cardiologist, Principal investigator, CHU Charles Nicolle - 1 rue Germont, 76000 ROUEN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175797
- Sponsor's protocol ID
- IBMR02 - IKONE
- Acronym
- IKONE
- Status last verified
- Apr 2019
- First submitted
- 4 Jun 2014
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the MRI Solution: KORA 100 and Beflex Pacing Leads System
- ClinicalTrials.gov ID
- NCT02175797
- Acronym / sponsor ID
- IKONE / IBMR02 - IKONE
- Conditions
- Bradycardia
- Keywords
- Pacemaker, leads and MRI exam
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- MicroPort CRMIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 26 Jun 2014 (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 purpose of this study is to report the stability of atrial and ventricular leads by absence of effect of the MRI exam on the pacing and sensing threshold and to report the safety based on the serious adverse events.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pacemaker + leads | Other | Device: MRIall patients must have a MRI exam after pacemaker implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient who is already implanted with following system KORA 100 (SR or DR) pacemaker and Beflex RF45D and/or RF46D pacing leads in the left or right pectoral region
- Patient who is able and willing out-of-chest non medical indicated MRI scanning OR patients with planned medical indicated out of chest MRI scanning
- Patient who fulfils MRI solutions conditions
- Patient who provides signed and dated informed consent
Key exclusion criteria (10 listed)
- Implanted or planned to be implanted non MR-compatible device or material
- Permanent Atrial Fibrillation (for DR devices)
- Diaphragmatic/phrenic stimulation
- Claustrophobia
- Incessant ventricular tachyarrhythmia
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 |
|---|---|---|
| MRIat least 6 weeks after the implantation of the pacemaker a MRI exam is performed | Device | Pacemaker + leads |
Primary outcome
Measure the atrial and ventricular pacing thresholds in Volts before and after the MRI exam, using the programmer.
Time frame: 1 month
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 23 Apr 2019.
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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.
Arnaud Mr SAVOURE, cardiologist principal investigator
CHU Charles Nicolle - 1 rue Germont, 76000 ROUEN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Bradycardia, run by MicroPort CRM at 1 site in France.
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 4 inclusion and 10 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 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Measure the atrial and ventricular pacing thresholds in Volts before and after the MRI exam, using the programmer. (time frame: 1 month). 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 23 Apr 2019.