HypertensionPhase 2NCT01077180
Rheos Feasibility Trial
A Phase 2 study testing Implantation of the Rheos System in people with Hypertension, run by CVRx, Inc..
Trial summary
The Rheos Feasibility Trial is designed to assess safety, device performance, and protocol parameters of the CVRx Rheos Baroreflex Therapy in patients with severe hypertension that are refractory to full drug therapy. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Implantation of the Rheos System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Oct 2010
- Phase
- Phase 2
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 21 years of age.
- Have been assessed to have bilateral carotid bifurcations located at or below C3-C4.
- Have an office cuff systolic blood pressure greater than or equal to 160 mmHg and a 24-hour ambulatory systolic blood pressure greater than or equal to 150 mmHg despite at least one month of full therapy with at least three (3) anti-hypertensive medications, of which at least one (1) must be a diuretic.
- Must be certified by the investigator hypertension specialist as compliant with taking full doses of medication.
- Have signed a CVRx approved informed consent for participation in this study.
Who cannot join
- Have been diagnosed with:
- Baroreflex failure
- Cardiac bradyarrhythmias
- Chronic atrial fibrillation
- Had a heart transplant
- Have carotid atherosclerosis producing a 50% or greater reduction in linear diameter as determined by ultrasound or angiographic evaluation as determined within six months of enrollment in the trial.
Show all 17Show fewer
- Have Grade C ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation.
- Have prior surgery or radiation in either carotid sinus region.
- Currently have implanted electrical medical devices such as cardiac pacing, defibrillation or neurologic stimulation systems.
- Are pregnant or contemplating pregnancy during the 13-month follow-up period.
- Currently undergoing dialysis.
- Have hypertension secondary to a treatable cause.
- Have clinically significant cardiac valvular disease.
- Are unable or unwilling to fulfill the protocol medication compliance and follow-up requirements.
- Are unlikely to survive the protocol follow-up period.
- Are enrolled in another concurrent clinical trial.
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About this study
Official title: Rheos Feasibility Trial- A Study of Baroreflex Hypertension TherapyTM in Refractory Hypertension
The Rheos Feasibility Trial is designed to assess safety, device performance, and protocol parameters of the CVRx Rheos Baroreflex Therapy in patients with severe hypertension that are refractory to full drug therapy.
- Conditions
- Hypertension
- Being tested
- Implantation of the Rheos System, Standard of care medical management
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of the Rheos SystemDevice
Open label
Standard of care medical managementOther
Patients will continue with medical therapy for standard of care of their hypertension.
| Study group | Role | What they receive |
|---|---|---|
| Rheos Device | Experimental | Not described Receives: Device: Implantation of the Rheos System |
| Medical Management | Active comparator | Not described Receives: Other: Standard of care medical management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rheos Feasibility Study
To summarize the efficacy of the Rheos System by estimating the reduction of systolic blood pressure associated with activation of the Rheos System at 4 and 13 months post implant when compared to baseline (1-month post implant).
To describe the safety of the Rheos System by summarizing all system related adverse events and estimating the serious sytem related event-free rate through 4 and 13 months post-implant.
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2010 (estimated)
- Study startJan 2005
- Primary completionDec 2007
- Study completionOct 2010
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- CVRx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01077180
- Sponsor's protocol ID
- 360005-001
- Status last verified
- Oct 2016
- First submitted
- 25 Feb 2010
- Last updated
- 2 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rheos Feasibility Trial- A Study of Baroreflex Hypertension TherapyTM in Refractory Hypertension
- ClinicalTrials.gov ID
- NCT01077180
- Acronym / sponsor ID
- 360005-001
- Conditions
- Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- CVRx, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 26 Feb 2010 (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.
The Rheos Feasibility Trial is designed to assess safety, device performance, and protocol parameters of the CVRx Rheos Baroreflex Therapy in patients with severe hypertension that are refractory to full drug therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rheos Device | Experimental | Device: Implantation of the Rheos System |
| Medical Management | Active comparator | Other: Standard of care medical management |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be at least 21 years of age.
- Have been assessed to have bilateral carotid bifurcations located at or below C3-C4.
- Have an office cuff systolic blood pressure greater than or equal to 160 mmHg and a 24-hour ambulatory systolic blood pressure greater than or equal to 150 mmHg despite at least one month of full therapy with at least three (3) anti-hypertensive medications, of which at least one (1) must be a diuretic.
- Must be certified by the investigator hypertension specialist as compliant with taking full doses of medication.
- Have signed a CVRx approved informed consent for participation in this study.
Key exclusion criteria (17 listed)
- Have been diagnosed with:
- Had a heart transplant
- Have carotid atherosclerosis producing a 50% or greater reduction in linear diameter as determined by ultrasound or angiographic evaluation as determined within six months of enrollment in the trial.
- Have Grade C ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation.
- Have prior surgery or radiation in either carotid sinus region.
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 |
|---|---|---|
| Implantation of the Rheos SystemOpen label | Device | Rheos Device |
| Standard of care medical managementPatients will continue with medical therapy for standard of care of their hypertension. | Other | Medical Management |
Primary outcome
Rheos Feasibility Study
Time frame: 13 months
To summarize the efficacy of the Rheos System by estimating the reduction of systolic blood pressure associated with activation of the Rheos System at 4 and 13 months post implant when compared to baseline (1-month post implant). To describe the safety of the Rheos System by summarizing all system related adverse events and estimating the serious sytem related event-free rate through 4 and 13 months post-implant.
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 2 Jul 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?
A Phase 2 study testing Implantation of the Rheos System in people with Hypertension, run by CVRx, 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 5 inclusion and 17 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 2 Jul 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Rheos Feasibility Study (time frame: 13 months). 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 2 Jul 2019.