Mitral RegurgitationVELOCITYNCT02858245
A Feasibility Registry of Actigraphy Monitoring in Degenerative Mitral Regurgitation Subjects Receiving the MitraClip® Device
An observational study of Mitral Regurgitation, run by Abbott Medical Devices at 8 sites in United States.
Trial summary
A prospective, open-label, and multi-centered feasibility registry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation
- How many people
- 30 participants
- Where
- 8 sitesUnited States
- Study dates
- Nov 2016to Dec 2017
- 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: Prohibitive risk degenerative mitral regurgitation (DMR) patients who receive at least 1 commercial MitraClip
Who may be able to join
- Subject must consent to receiving the MitraClip device
- Subject must consent, be able, and commit to wearing the Actiwatch continuously for approximately 7 months
- Subject must consent to use of their data from this registry for purposes of exploratory research and publication and presentation
Who cannot join
- Subject is not a member of vulnerable population
- Subject must not have any disabilities that preclude reliable data collection from the Actiwatch, e.g., epilepsy with uncontrolled recurring episodes, serious stage degenerative/disabling disease (e.g. Parkinson's disease), inability to walk or will require walking aids, etc.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Colorado Hospital
Aurora, Colorado, 80045
Carolinas Medical Center
Charlotte, North Carolina, 28203
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Baptist Hospital of Miami
Miami, Florida, 33176
Banner University Medical Center
Phoenix, Arizona, 85006
Bon Secours St Mary's Hospital
Richmond, Virginia, 23226
Mayo Foundation for Medical Education and Research
Rochester, Minnesota, 55905
About this study
Official title: A Feasibility Registry on Use of Actigraphy Monitoring in Degenerative Mitral Regurgitation (DMR) Subjects Receiving the MitraClip® Device
A prospective, open-label, and multi-centered feasibility registry.
Read the detailed description
This is a prospective, open-label, and multi-centered feasibility registry (single arm study). Approximately 36 subjects with prohibitive risk degenerative mitral regurgitation (DMR) who receive at least 1 commercial MitraClip will be registered at up to 10 US sites.
- Conditions
- Mitral Regurgitation
- Being tested
- No intervention - registry
- Keywords
- MitraClip, Structural Heart Failure, Degenerative Mitral Regurgitation (DMR), Actigraphy
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention - registryOther
| Study group | Role | What they receive |
|---|---|---|
| Commercial MitraClip® patients | Patients with Degenerative Mitral Regurgitation receiving MitraClip® Device Receives: Other: No intervention - registry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observational change in daily reported activity levels (counts/min) as assessed by actigraphy, from baseline to 30 days post MitraClip implantation
Phillips Actiwatch Spectrum PRO is the device being used to capture the primary outcome measure
Measured: At 30 days
Secondary outcomes (20)
Levels of daily and weekly activity as assessed by actigraphy
Measured: Pre-procedure (on day 0)
Levels of daily and weekly activity as assessed by actigraphy
Measured: Post-procedure (≤ 7 days)
Levels of daily and weekly activity as assessed by actigraphy
Measured: At 30 days
Levels of daily and weekly activity as assessed by actigraphy
Measured: At 2 months
Levels of daily and weekly activity as assessed by actigraphy
Measured: At 3 months
Levels of daily and weekly activity as assessed by actigraphy
Measured: At 4 months
Levels of daily and weekly activity as assessed by actigraphy
Measured: At 5 months
Patterns of daily Sleep/Wake by actigraphy
Measured: At 6 months
NYHA Functional Class
Measured: At Baseline
NYHA Functional Class
Measured: At 30 days
Mitral Regurgitation severity
Measured: At Baseline
Mitral Regurgitation severity
Measured: Post-procedure (≤ 7 days)
Mitral Regurgitation severity
Measured: At 30 days
Echocardiographic assessment
Measured: At Baseline
Echocardiographic assessment
Measured: Post-procedure (≤ 7 days)
Echocardiographic assessment
Measured: At 30 days
Distance walked 6 minute walk test (6MWT)
Measured: At Baseline
Distance walked 6 minute walk test (6MWT)
Measured: At 30 days
Health-related quality of life (QoL)
Measured: At Baseline
Health-related quality of life (QoL)
Measured: At 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2017
- Study completionDec 2017
Why it stopped: Study has been terminated due to small sample size
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Staehr, MD, Study director, Abbott Medical Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02858245
- Sponsor's protocol ID
- 16-6001
- Acronym
- VELOCITY
- Status last verified
- May 2017
- First submitted
- 20 Jul 2016
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Registry on Use of Actigraphy Monitoring in Degenerative Mitral Regurgitation (DMR) Subjects Receiving the MitraClip® Device
- ClinicalTrials.gov ID
- NCT02858245
- Acronym / sponsor ID
- VELOCITY / 16-6001
- Conditions
- Mitral Regurgitation
- Keywords
- MitraClip, Structural Heart Failure, Degenerative Mitral Regurgitation (DMR), Actigraphy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study has been terminated due to small sample size
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Nov 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 8 Aug 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.
A prospective, open-label, and multi-centered feasibility registry.
Detailed description
This is a prospective, open-label, and multi-centered feasibility registry (single arm study). Approximately 36 subjects with prohibitive risk degenerative mitral regurgitation (DMR) who receive at least 1 commercial MitraClip will be registered at up to 10 US sites.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Commercial MitraClip® patients | – | Other: No intervention - registryPatients with Degenerative Mitral Regurgitation receiving MitraClip® Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prohibitive risk degenerative mitral regurgitation (DMR) patients who receive at least 1 commercial MitraClip
Key inclusion criteria (3 listed)
- Subject must consent to receiving the MitraClip device
- Subject must consent, be able, and commit to wearing the Actiwatch continuously for approximately 7 months
- Subject must consent to use of their data from this registry for purposes of exploratory research and publication and presentation
Key exclusion criteria (2 listed)
- Subject is not a member of vulnerable population
- Subject must not have any disabilities that preclude reliable data collection from the Actiwatch, e.g., epilepsy with uncontrolled recurring episodes, serious stage degenerative/disabling disease (e.g. Parkinson's disease), inability to walk or will require walking aids, etc.
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 |
|---|---|---|
| No intervention - registry | Other | Commercial MitraClip® patients |
Primary outcome
Observational change in daily reported activity levels (counts/min) as assessed by actigraphy, from baseline to 30 days post MitraClip implantation
Time frame: At 30 days
Phillips Actiwatch Spectrum PRO is the device being used to capture the primary outcome measure
20 secondary outcomes
Levels of daily and weekly activity as assessed by actigraphy
Time frame: Pre-procedure (on day 0)
Levels of daily and weekly activity as assessed by actigraphy
Time frame: Post-procedure (≤ 7 days)
Levels of daily and weekly activity as assessed by actigraphy
Time frame: At 30 days
Levels of daily and weekly activity as assessed by actigraphy
Time frame: At 2 months
Levels of daily and weekly activity as assessed by actigraphy
Time frame: At 3 months
Levels of daily and weekly activity as assessed by actigraphy
Time frame: At 4 months
Levels of daily and weekly activity as assessed by actigraphy
Time frame: At 5 months
Patterns of daily Sleep/Wake by actigraphy
Time frame: At 6 months
NYHA Functional Class
Time frame: At Baseline
NYHA Functional Class
Time frame: At 30 days
Mitral Regurgitation severity
Time frame: At Baseline
Mitral Regurgitation severity
Time frame: Post-procedure (≤ 7 days)
Mitral Regurgitation severity
Time frame: At 30 days
Echocardiographic assessment
Time frame: At Baseline
Echocardiographic assessment
Time frame: Post-procedure (≤ 7 days)
Echocardiographic assessment
Time frame: At 30 days
Distance walked 6 minute walk test (6MWT)
Time frame: At Baseline
Distance walked 6 minute walk test (6MWT)
Time frame: At 30 days
Health-related quality of life (QoL)
Time frame: At Baseline
Health-related quality of life (QoL)
Time frame: At 30 days
Results and safety
The study was stopped early (reason given: Study has been terminated due to small sample size). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
- Individual participant dataSharing planned: No
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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.
Peter Staehr, MD study director
Abbott Medical Devices
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Regurgitation, run by Abbott Medical Devices at 8 sites in United States.
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: stopped early, as of the sponsor's last update on 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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 was stopped early (reason given: Study has been terminated due to small sample size). Results are not available in the source record.
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?
Observational change in daily reported activity levels (counts/min) as assessed by actigraphy, from baseline to 30 days post MitraClip implantation (time frame: At 30 days). 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 May 2018.