HypertensionCALM-STARTNCT02804087
Controlling And Lowering Blood Pressure With the MobiusHDTM Device
A study testing MobiusHD in people with Hypertension, run by Vascular Dynamics, Inc. at 4 sites in Netherlands.
Trial summary
To evaluate the safety and performance of the MobiusHD system in subjects with resistant hypertension. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- MobiusHD
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 4 sitesNetherlands
- Study dates
- 24 Aug 2017to 21 Jul 2021
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-70 years;
- Diagnosed with resistant hypertension;
- A mean systolic 24-hour ABP of 135-170 mmHg following at least 30 days on a stable antihypertensive medication regimen (no changes in medications or dose).
- A mean systolic 24-hour ABP of 135-170 mmHg after washout of all antihypertensive medications.
Who cannot join
- Known or clinically suspected baroreflex failure or autonomic neuropathy
- Treatable cause of resistant hypertension
- Hypertension secondary to an identifiable and treatable cause other than sleep apnea
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
Maastricht UMC+
Maastricht, 6229
St. Antonius Ziekenhuis
Nieuwegein, 3435 CM
HagaZiekenhuis
The Hague, AA, 2545
UMCU
Utrecht, 3508 GA
About this study
Official title: CALM-START - Controlling And Lowering Blood Pressure With the MobiusHDTM Device: STudying Effects in A Randomized Trial
To evaluate the safety and performance of the MobiusHD system in subjects with resistant hypertension.
Read the detailed description
This is a prospective, randomized, double-blind, sham-controlled, multi-center post market study investigating the efficacy and safety of MobiusHD System, and the efficacy of the MobiusHD device in lowering mean systolic 24-hour ABP in subjects with resistant hypertension.
- Conditions
- Hypertension
- Being tested
- MobiusHD, Sham Implantation
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MobiusHDDevice
The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter.
Sham ImplantationOther
Sham Implantation
| Study group | Role | What they receive |
|---|---|---|
| MobiusHD Implantation | Experimental | Not described Receives: Device: MobiusHD |
| Sham Implantation | Sham comparator | Sham Receives: Other: Sham Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in mean systolic 24-hour ABP from baseline to 90 days post-randomization, between the treatment arm and the sham arm.
Reduction in mean systolic 24-hour ABP
Measured: From Baseline to 90 days post-randomization
Secondary outcomes (1)
Major adverse clinical events, including death, stroke, carotid interventions, and myocardial infarction, from baseline to 30 days post-randomization, between the treatment arm and the sham arm.
Adverse Events
Measured: From Baseline to 30 days post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study start24 Aug 2017
- Primary completion30 Jun 2021
- Study completion21 Jul 2021
Why it stopped: Due to the rigorous nature of the trial and enrollment interruptions caused by COVID-19, the study enrolled only 4 of the planned 110 subjects. Due to the lack of enrollment, the study was closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vascular Dynamics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wilko Spiering, MD, Principal investigator, UMC UtrechtJan Van der Heyden, MD, Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804087
- Sponsor's protocol ID
- CRD0339
- Acronym
- CALM-START
- Status last verified
- Oct 2023
- First submitted
- 14 Jun 2016
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CALM-START - Controlling And Lowering Blood Pressure With the MobiusHDTM Device: STudying Effects in A Randomized Trial
- ClinicalTrials.gov ID
- NCT02804087
- Acronym / sponsor ID
- CALM-START / CRD0339
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the rigorous nature of the trial and enrollment interruptions caused by COVID-19, the study enrolled only 4 of the planned 110 subjects. Due to the lack of enrollment, the study was closed.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Vascular Dynamics, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Aug 2017 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 21 Jul 2021 (actual)
- First posted
- 17 Jun 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.
To evaluate the safety and performance of the MobiusHD system in subjects with resistant hypertension.
Detailed description
This is a prospective, randomized, double-blind, sham-controlled, multi-center post market study investigating the efficacy and safety of MobiusHD System, and the efficacy of the MobiusHD device in lowering mean systolic 24-hour ABP in subjects with resistant hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MobiusHD Implantation | Experimental | Device: MobiusHD |
| Sham Implantation | Sham comparator | Other: Sham ImplantationSham |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18-70 years;
- Diagnosed with resistant hypertension;
- A mean systolic 24-hour ABP of 135-170 mmHg following at least 30 days on a stable antihypertensive medication regimen (no changes in medications or dose).
- A mean systolic 24-hour ABP of 135-170 mmHg after washout of all antihypertensive medications.
Key exclusion criteria (3 listed)
- Known or clinically suspected baroreflex failure or autonomic neuropathy
- Treatable cause of resistant hypertension
- Hypertension secondary to an identifiable and treatable cause other than sleep apnea
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 |
|---|---|---|
| MobiusHDThe MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter. | Device | MobiusHD Implantation |
| Sham ImplantationSham Implantation | Other | Sham Implantation |
Primary outcome
The change in mean systolic 24-hour ABP from baseline to 90 days post-randomization, between the treatment arm and the sham arm.
Time frame: From Baseline to 90 days post-randomization
Reduction in mean systolic 24-hour ABP
1 secondary outcome
Major adverse clinical events, including death, stroke, carotid interventions, and myocardial infarction, from baseline to 30 days post-randomization, between the treatment arm and the sham arm.
Time frame: From Baseline to 30 days post-randomization
Results and safety
The study was stopped early (reason given: Due to the rigorous nature of the trial and enrollment interruptions caused by COVID-19, the study enrolled only 4 of the planned 110 subjects. Due to the lack of enrollment, the study was closed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- 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.
Wilko Spiering, MD principal investigator
UMC Utrecht
Jan Van der Heyden, MD principal investigator
St. Antonius Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MobiusHD in people with Hypertension, run by Vascular Dynamics, Inc. at 4 sites in Netherlands.
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 3 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 10 Oct 2023. 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 Netherlands. 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. Some participants in this study may receive a placebo. 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: Due to the rigorous nature of the trial and enrollment interruptions caused by COVID-19, the study enrolled only 4 of the planned 110 subjects. Due to the lack of enrollment, the study was closed.). 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?
The change in mean systolic 24-hour ABP from baseline to 90 days post-randomization, between the treatment arm and the sham arm. (time frame: From Baseline to 90 days post-randomization). 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 10 Oct 2023.