TachyarrhythmiaNCT02933619
ProMRI ICD/CRT-D Post Approval Study
An observational study of Tachyarrhythmia, run by Biotronik, Inc..
Trial summary
Following product approval, confirmation of appropriate VF episode detection after MRI exposure of the ProMRI ICD/CRT-D systems and to evaluate left ventricular pacing threshold changes post-MRI. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tachyarrhythmia
- How many people
- 24,249 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Apr 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: ProMRI ICD/CRT-D system enabled with BIOTRONIK Home Monitoring.
Who may be able to join
- ProMRI ICD/CRT-D system enabled with BIOTRONIK Home Monitoring.
Who cannot join
- None
About this study
Following product approval, confirmation of appropriate VF episode detection after MRI exposure of the ProMRI ICD/CRT-D systems and to evaluate left ventricular pacing threshold changes post-MRI.
- Conditions
- Tachyarrhythmia
- Medical subject headings
- Tachycardia
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of ICD/CRT-D subjects with a ≥ 5 second delay in post-MRI VF detection.
Primary objectives will be analyzed once 25 subjects implanted with the ProMRI ICD system have been identified with a documented true VF episode post-MRI.
Measured: Up to 5 years post-approval
Proportion of LV pacing leads with a LV pacing threshold increase > 1V between pre-MRI and one-month post-MRI.
Measured: Up to 5 years post-approval
Secondary outcomes (2)
Workflow compliance following MR exposure
Proportion of subjects with appropriate restoration of tachycardia detection and ICD therapy post-MRI.
Measured: Up to 5 years post-approval
Left ventricular sensing attenuation
Proportion of subjects who experience left ventricular sensing amplitude attenuation >50% between pre-MRI and 30 days post-MRI.
Measured: Up to 5 years post-approval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study startAug 2016
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TachyarrhythmiaStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 24,249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02933619
- Sponsor's protocol ID
- ProMRI PAS
- Status last verified
- Oct 2019
- First submitted
- 10 Oct 2016
- Last updated
- 22 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ProMRI ICD/CRT-D Post Approval Study
- ClinicalTrials.gov ID
- NCT02933619
- Acronym / sponsor ID
- ProMRI PAS
- Conditions
- Tachyarrhythmia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24,249 participants (actual)
- Lead sponsor
- Biotronik, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 14 Oct 2016 (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.
Following product approval, confirmation of appropriate VF episode detection after MRI exposure of the ProMRI ICD/CRT-D systems and to evaluate left ventricular pacing threshold changes post-MRI.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- ProMRI ICD/CRT-D system enabled with BIOTRONIK Home Monitoring.
Key inclusion criteria (1 listed)
- ProMRI ICD/CRT-D system enabled with BIOTRONIK Home Monitoring.
Key exclusion criteria (1 listed)
- None
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
Proportion of ICD/CRT-D subjects with a ≥ 5 second delay in post-MRI VF detection.
Time frame: Up to 5 years post-approval
Primary objectives will be analyzed once 25 subjects implanted with the ProMRI ICD system have been identified with a documented true VF episode post-MRI.
Proportion of LV pacing leads with a LV pacing threshold increase > 1V between pre-MRI and one-month post-MRI.
Time frame: Up to 5 years post-approval
2 secondary outcomes
Workflow compliance following MR exposure
Time frame: Up to 5 years post-approval
Left ventricular sensing attenuation
Time frame: Up to 5 years post-approval
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 22 Oct 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.
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 Tachyarrhythmia, run by Biotronik, Inc..
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 1 inclusion and 1 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 22 Oct 2019. 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?
Proportion of ICD/CRT-D subjects with a ≥ 5 second delay in post-MRI VF detection. (time frame: Up to 5 years post-approval). The study lists 2 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 22 Oct 2019.