Need for MRI Imaging With Pacemaker or Implantable Cardioverter Defibrillator ImplantedNCT02380300
Registry Study of Clinical Application of MRI Compatible CIED
An observational study of Need for MRI Imaging With Pacemaker or Implantable Cardioverter Defibrillator Implanted, run by Biotronik (Beijing) Medical Device Ltd..
Trial summary
The purpose of this study is to clear the Safety and Necessity of the Magnetic Resonance Imaging (MRI) in the Presence of CIEDs(Cardiovascular Implantable Electronic Devices). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Need for MRI Imaging With Pacemaker or Implantable Cardioverter Defibrillator Implanted
- How many people
- 2,067 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2015to Sep 2020
- How long will I take part?
- 2 Years
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ProMRI CIED implanted，including ProMRI Pacemaker/CRT and ProMRI ICD/CRTD
- Inclusion criteria
- Patient is >18 years old
- Patient implanted with a Biotronik MRI compatible CIED (including the pacemaker, cardiac resynchronization therapy, implantable cardioverter defibrillator, and cardiac resynchronization therapy-defibrillator) in the past two months
- Patient has provided a written informed consent
- Patient's height is≥140cm
- Exclusion criteria
- Have other medical implants that may interact with MRI, e.g. abandoned pacemaker/ICD leads, lead extensions, mechanical valves, other active medical devices, non-MRI compatible devices
- Life expectancy less than 2 years
- Pregnant and/or breat-feeding females or females who intend to become pregnant in next two years
- Patient is currently participating in another study
- In the investigator's opinion patient will not be able to comply with the follow-up requirements
About this study
The purpose of this study is to clear the Safety and Necessity of the Magnetic Resonance Imaging (MRI) in the Presence of CIEDs(Cardiovascular Implantable Electronic Devices).
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious adverse events
Measured: two years
The raise of Impedance Threshold of the Atrial and Ventricle
Measured: immediate；one month
RA sensing amplitude (daily mean): < 1.5 mV or RV sensing amplitude (daily min.): < 2.0 mV
Measured: immediate；one month
The proportion of patients with CIED who need MRI examination
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study start15 Mar 2015
- Primary completionSep 2020
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Need for MRI Imaging With Pacemaker or Implantable Cardioverter Defibrillator ImplantedStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,067 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Biotronik (Beijing) Medical Device Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380300
- Sponsor's protocol ID
- 2015-01
- Status last verified
- Aug 2022
- First submitted
- 2 Mar 2015
- Last updated
- 17 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry Study of Clinical Application of MRI Compatible CIED
- ClinicalTrials.gov ID
- NCT02380300
- Acronym / sponsor ID
- 2015-01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,067 participants (actual)
- Lead sponsor
- Biotronik (Beijing) Medical Device Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Mar 2015 (actual)
- Primary completion
- Sep 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 5 Mar 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 purpose of this study is to clear the Safety and Necessity of the Magnetic Resonance Imaging (MRI) in the Presence of CIEDs(Cardiovascular Implantable Electronic Devices).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ProMRI CIED implanted，including ProMRI Pacemaker/CRT and ProMRI ICD/CRTD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serious adverse events
Time frame: two years
The raise of Impedance Threshold of the Atrial and Ventricle
Time frame: immediate；one month
RA sensing amplitude (daily mean): < 1.5 mV or RV sensing amplitude (daily min.): < 2.0 mV
Time frame: immediate；one month
The proportion of patients with CIED who need MRI examination
Time frame: two years
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 17 Aug 2022.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Need for MRI Imaging With Pacemaker or Implantable Cardioverter Defibrillator Implanted, run by Biotronik (Beijing) Medical Device Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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 events (time frame: two years). The study lists 4 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 17 Aug 2022.