BradyarrhythmiaMASS2NCT02930980
Micra Accelerometer Sensor Study 2
A study testing Investigational Software loaded on Micra device in people with Bradyarrhythmia, run by Medtronic Cardiac Rhythm and Heart Failure at 4 sites in 3 countries.
Trial summary
The purpose of the MASS2 is to characterize accelerometer signals of Micra implantable device during different postures and activities and to understand the source of the sensed motion, in order to test feasibility for future enhancements in device functionalities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradyarrhythmia
- What is being tested?
- Investigational Software loaded on Micra device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 14 Oct 2016to 25 Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subject is ≥ 18 years old
- Subject is implanted with a Micra device
- Subject or witness (if applicable as per local regulation) is able and willing to provide Informed Consent
Who cannot join
- Subject is in atrial fibrillation
- Subject is not able to perform study requirements
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
France2 sites
Hôpital cardiologique du Haut-Lévêque
Pessac
CHRU Tours - Hopital Trousseau
Tours
About this study
The purpose of the MASS2 is to characterize accelerometer signals of Micra implantable device during different postures and activities and to understand the source of the sensed motion, in order to test feasibility for future enhancements in device functionalities.
- Conditions
- Bradyarrhythmia
- Being tested
- Investigational Software loaded on Micra device
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Software loaded on Micra deviceDevice
Subject will receive an investigational software loaded on subject's Micra device
| Study group | Role | What they receive |
|---|---|---|
| Investigational Software | Experimental | Investigational Software loaded on Micra device Receives: Device: Investigational Software loaded on Micra device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waveform and Components of Accelerometer Signal
Accelerometer signal was measured using the 3 axis Micra accelerometer (Vector 1 was labelled as V1, Vector 2 as V2, Vector 3 as V3).
Components of the accelerometer signals (unit (g) represent acceleration)were identified and labelled as A1 (acceleration associated with ventricular systole), A2 (ventricular diastole), A3 (early passive filling), and A4 (active filling). The A4 signal is associated with atrial contraction and active filling.
Measured: For approximately two hours after software download
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study start14 Oct 2016
- Primary completion25 Apr 2017
- Study completion25 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BradyarrhythmiaStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02930980
- Sponsor's protocol ID
- MDT16023
- Acronym
- MASS2
- Status last verified
- Nov 2018
- First submitted
- 6 Oct 2016
- Last updated
- 11 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chinitz L, Ritter P, Khelae SK, Iacopino S, Garweg C, Grazia-Bongiorni M, Neuzil P, Johansen JB, Mont L, Gonzalez E, Sagi V, Duray GZ, Clementy N, Sheldon T, Splett V, Stromberg K, Wood N, Steinwender C. Accelerometer-based atrioventricular synchronous pacing with a ventricular leadless pacemaker: Results from the Micra atrioventricular feasibility studies. Heart Rhythm. 2018 Sep;15(9):1363-1371. doi: 10.1016/j.hrthm.2018.05.004. Epub 2018 May 11.
PubMed 29758405
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micra Accelerometer Sensor Study 2
- ClinicalTrials.gov ID
- NCT02930980
- Acronym / sponsor ID
- MASS2 / MDT16023
- Conditions
- Bradyarrhythmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2016 (actual)
- Primary completion
- 25 Apr 2017 (actual)
- Study completion
- 25 Apr 2017 (actual)
- First posted
- 12 Oct 2016 (estimated)
- Results
- Posted 11 Mar 2019
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 the MASS2 is to characterize accelerometer signals of Micra implantable device during different postures and activities and to understand the source of the sensed motion, in order to test feasibility for future enhancements in device functionalities.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational Software | Experimental | Device: Investigational Software loaded on Micra deviceInvestigational Software loaded on Micra device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is ≥ 18 years old
- Subject is implanted with a Micra device
- Subject or witness (if applicable as per local regulation) is able and willing to provide Informed Consent
Key exclusion criteria (2 listed)
- Subject is in atrial fibrillation
- Subject is not able to perform study requirements
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 |
|---|---|---|
| Investigational Software loaded on Micra deviceSubject will receive an investigational software loaded on subject's Micra device | Device | Investigational Software |
Primary outcome
Waveform and Components of Accelerometer Signal
Time frame: For approximately two hours after software download
Accelerometer signal was measured using the 3 axis Micra accelerometer (Vector 1 was labelled as V1, Vector 2 as V2, Vector 3 as V3). Components of the accelerometer signals (unit (g) represent acceleration)were identified and labelled as A1 (acceleration associated with ventricular systole), A2 (ventricular diastole), A3 (early passive filling), and A4 (active filling). The A4 signal is associated with atrial contraction and active filling.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29758405Chinitz L, Ritter P, Khelae SK, Iacopino S, Garweg C, Grazia-Bongiorni M, Neuzil P, Johansen JB, Mont L, Gonzalez E, Sagi V, Duray GZ, Clementy N, Sheldon T, Splett V, Stromberg K, Wood N, Steinwender C. Accelerometer-based atrioventricular synchronous pacing with a ventricular leadless pacemaker: Results from the Micra atrioventricular feasibility studies. Heart Rhythm. 2018 Sep;15(9):1363-1371. doi: 10.1016/j.hrthm.2018.05.004. Epub 2018 May 11.
- Individual participant dataSharing planned: Undecided
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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.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational Software loaded on Micra device in people with Bradyarrhythmia, run by Medtronic Cardiac Rhythm and Heart Failure at 4 sites in 3 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 3 inclusion and 2 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 11 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Austria, Spain. 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?
Yes. Results are posted in the registry (first posted 11 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Waveform and Components of Accelerometer Signal (time frame: For approximately two hours after software download). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02930980, which also lists 1 linked publication.
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 11 Mar 2019.