HypertensionCALM-2NCT03179800
CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD™
A study testing MobiusHD in people with Hypertension and Resistant Hypertension, run by Vascular Dynamics, Inc. at 6 sites in 2 countries.
Trial summary
The objective of this study is to evaluate the safety and effectiveness of the MobiusHD System in a prospective, randomized, double-blind, sham-controlled multi-center pivotal study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension, Resistant 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
- 300 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 19 Oct 2017to May 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mean 24 hour ambulatory systolic blood pressure ≥145 mmHg and ≤200 mmHg and stable for at least 8 weeks on a maximally tolerated guideline directed, (JNC8) or their equivalent when those listed are not available dosing regimen consisting of up to 5 antihypertensive medications, with a minimum required dosing regimen of an "A+C+D" antihypertensive medication regimen, where "A" is an angiotensin-converting enzyme Inhibitor or an angiotensin receptor blocker, "C" is a calcium channel blocker, and "D" is a diuretic.
Who cannot join
- Inadequacy of the carotid anatomy for treatment with the MobiusHD based on carotid angiography.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Emory University Hospital Midtown
Atlanta, Georgia, 30308
The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital
Cincinnati, Ohio, 45219
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, 46290
Ochsner Medical Center
New Orleans, Louisiana, 70121
Southern Illinois University
Springfield, Illinois, 62702
About this study
The objective of this study is to evaluate the safety and effectiveness of the MobiusHD System in a prospective, randomized, double-blind, sham-controlled multi-center pivotal study.
Read the detailed description
The objective of this study is to evaluate the safety and effectiveness of the MobiusHD System in a prospective, randomized, double-blind, sham-controlled multi-center pivotal study. Patients with resistant hypertension who remain uncontrolled despite pharmacologic treatment with maximum tolerated, guideline-directed anti-hypertensive pharmacologic therapy will be evaluated.
- Conditions
- Hypertension, Resistant Hypertension
- Being tested
- MobiusHD, Sham Implantation
- Keywords
- Hypertension, Resistant Hypertension, Baroreceptor, BAT
- 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 | MobiusHD Implantation Receives: Device: MobiusHD |
| Sham Implantation | Sham comparator | Sham Implantation Receives: Other: Sham Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Endpoint - Change in mean 24-hr sABP from baseline to 180-day
The primary effectiveness endpoint is change in mean 24-hr ambulatory systolic blood pressure (24hr sABP) from baseline to the 180-day visit.
Measured: 180-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start19 Oct 2017
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vascular Dynamics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bryan Williams, MD, Study chair, University College, LondonGregg Stone, MD, Study chair, Cardiovascular Research and Education Columbia University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03179800
- Sponsor's protocol ID
- CRD0447
- Acronym
- CALM-2
- Status last verified
- Jul 2024
- First submitted
- 30 May 2017
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Calhoun DA, Schiffrin EL, Flack JM. Resistant Hypertension: An Update. Am J Hypertens. 2019 Jan 1;32(1):1-3. doi: 10.1093/ajh/hpy156. No abstract available.
PubMed 30407514
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD™
- ClinicalTrials.gov ID
- NCT03179800
- Acronym / sponsor ID
- CALM-2 / CRD0447
- Conditions
- Hypertension, Resistant Hypertension
- Keywords
- Hypertension, Resistant Hypertension, Baroreceptor, BAT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Vascular Dynamics, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Oct 2017 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 7 Jun 2017 (actual)
- 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 objective of this study is to evaluate the safety and effectiveness of the MobiusHD System in a prospective, randomized, double-blind, sham-controlled multi-center pivotal study.
Detailed description
The objective of this study is to evaluate the safety and effectiveness of the MobiusHD System in a prospective, randomized, double-blind, sham-controlled multi-center pivotal study. Patients with resistant hypertension who remain uncontrolled despite pharmacologic treatment with maximum tolerated, guideline-directed anti-hypertensive pharmacologic therapy will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MobiusHD Implantation | Experimental | Device: MobiusHDMobiusHD Implantation |
| Sham Implantation | Sham comparator | Other: Sham ImplantationSham Implantation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mean 24 hour ambulatory systolic blood pressure ≥145 mmHg and ≤200 mmHg and stable for at least 8 weeks on a maximally tolerated guideline directed, (JNC8) or their equivalent when those listed are not available dosing regimen consisting of up to 5 antihypertensive medications, with a minimum required dosing regimen of an "A+C+D" antihypertensive medication regimen, where "A" is an angiotensin-converting enzyme Inhibitor or an angiotensin receptor blocker, "C" is a calcium channel blocker, and "D" is a diuretic.
Key exclusion criteria (1 listed)
- Inadequacy of the carotid anatomy for treatment with the MobiusHD based on carotid angiography.
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
Primary Effectiveness Endpoint - Change in mean 24-hr sABP from baseline to 180-day
Time frame: 180-day
The primary effectiveness endpoint is change in mean 24-hr ambulatory systolic blood pressure (24hr sABP) from baseline to the 180-day visit.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Derived from this study: PubMed 30407514Calhoun DA, Schiffrin EL, Flack JM. Resistant Hypertension: An Update. Am J Hypertens. 2019 Jan 1;32(1):1-3. doi: 10.1093/ajh/hpy156. No abstract available.
- Related InfoLink provided by the sponsor.
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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.
Bryan Williams, MD study chair
University College, London
Gregg Stone, MD study chair
Cardiovascular Research and Education Columbia University Medical Center
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MobiusHD in people with Hypertension and Resistant Hypertension, run by Vascular Dynamics, Inc. at 6 sites in 2 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 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: status not confirmed, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, France. 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?
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?
Primary Effectiveness Endpoint - Change in mean 24-hr sABP from baseline to 180-day (time frame: 180-day). 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 NCT03179800, 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 18 Jul 2024.