Heart FailureNCT01484288
Baroreflex Activation Therapy in Heart Failure
A study testing Barostim Neo System in people with Heart Failure, run by CVRx, Inc. at 1 site in Italy.
Trial summary
The purpose of this clinical investigation is to evaluate the efficacy and safety of the CVRx Barostim Neo System in the treatment of patients with heart failure. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Barostim Neo System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2011to Mar 2015
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age at least 21 years
- Symptomatic heart failure despite optimal, stable pharmacological therapy for at least 4 weeks
Who cannot join
- Significant carotid plaque or stenosis
- Known or suspected baroreflex failure or autonomic neuropathy
- Myocardial infarction, unstable angina, syncope, cerebral vascular accident, SCD, or received defibrillation therapy within the past 3 months
- Heart failure secondary to a reversible condition
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this clinical investigation is to evaluate the efficacy and safety of the CVRx Barostim Neo System in the treatment of patients with heart failure.
- Conditions
- Heart Failure
- Being tested
- Barostim Neo System
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barostim Neo SystemDevice
Also called XR-1 System, Neo system
Baroreflex Activation Therapy using the Barostim Neo System
| Study group | Role | What they receive |
|---|---|---|
| Device group | Experimental | Barostim Neo system Receives: Device: Barostim Neo System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Sympathetic Nervous System Activity (MSNA Bursts/Min)
Change in muscle sympathetic nerve activity (MSNA) in bursts/min at 6 months compared to baseline
Measured: 6 months
Changes in Sympathetic Nervous System Activity (MSNA Bursts/100 Heartbeats)
Changes in Muscle Sympathetic Nerve Activity (bursts/100 heartbeats) at 6 months compared to baseline
Measured: 6 months
Secondary outcomes (7)
Change in Systolic Blood Pressure
Change in systolic blood pressure at 6 months compared to baseline
Measured: 6 months
Change in Diastolic Blood Pressure
Change in diastolic blood pressure at 6 months compared to baseline
Measured: 6 months
Change in Heart Rate
Change in heart rate at 6 months compared to baseline
Measured: 6 months
Change in Six-Minute Hall Walk
Change in six-minute hall walk distance at 6 months compared to baseline. The 6-Minute Hall Walk test is a measure of physical function by measuring the distance a patient can walk in a 6-minute time period.
Measured: 6 months
New York Heart Association (NYHA) Class
Number of patients with NYHA Class I-IV at 6 months. NYHA classification places patients in one of four categories based on how much they are limited during physical activity, where Class I indicates no limitation of physical activity and Class IV indicates the patient is unable to carry on any physical activity without discomfort. The patient has symptoms of heart failure at rest, and if any physical activity is undertaken, discomfort increases.
Measured: Six months
Change in Quality of Life (Minnesota Living With Heart Failure Questionnaire)
Change in Quality of Life as measured by the Minnesota Living with Heart Failure Questionnaire at 6 months compared to baseline.
The Minnesota Living with Heart Failure Questionnaire is a 21-item questionnaire designed as a measure of heart failure, as indicated by its adverse effects on patients' lives. Each item is scored in a 6-point Likert Scale (0 to 5); therefore, the total score could range from 0 to 105, with higher scores indicating more significant impairment in health-related quality of life.
Measured: Six months
Change in Left Ventricular Ejection Fraction (LVEF)
Change in LVEF at 6 months compared to baseline
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionJul 2013
- Study completionMar 2015
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.
- Other trials for Heart FailureStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- CVRx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edoardo G Gronda, MD, FESC, Principal investigator, MultiMedica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01484288
- Sponsor's protocol ID
- 360025
- Status last verified
- Aug 2021
- First submitted
- 29 Nov 2011
- Last updated
- 26 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baroreflex Activation Therapy in Heart Failure
- ClinicalTrials.gov ID
- NCT01484288
- Acronym / sponsor ID
- 360025
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- CVRx, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 2 Dec 2011 (estimated)
- Results
- Posted 26 Aug 2021
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 this clinical investigation is to evaluate the efficacy and safety of the CVRx Barostim Neo System in the treatment of patients with heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device group | Experimental | Device: Barostim Neo SystemBarostim Neo system |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age at least 21 years
- Symptomatic heart failure despite optimal, stable pharmacological therapy for at least 4 weeks
Key exclusion criteria (4 listed)
- Significant carotid plaque or stenosis
- Known or suspected baroreflex failure or autonomic neuropathy
- Myocardial infarction, unstable angina, syncope, cerebral vascular accident, SCD, or received defibrillation therapy within the past 3 months
- Heart failure secondary to a reversible condition
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 |
|---|---|---|
| Barostim Neo SystemAlso: XR-1 System, Neo systemBaroreflex Activation Therapy using the Barostim Neo System | Device | Device group |
Primary outcome
Changes in Sympathetic Nervous System Activity (MSNA Bursts/Min)
Time frame: 6 months
Change in muscle sympathetic nerve activity (MSNA) in bursts/min at 6 months compared to baseline
Changes in Sympathetic Nervous System Activity (MSNA Bursts/100 Heartbeats)
Time frame: 6 months
Changes in Muscle Sympathetic Nerve Activity (bursts/100 heartbeats) at 6 months compared to baseline
7 secondary outcomes
Change in Systolic Blood Pressure
Time frame: 6 months
Change in Diastolic Blood Pressure
Time frame: 6 months
Change in Heart Rate
Time frame: 6 months
Change in Six-Minute Hall Walk
Time frame: 6 months
New York Heart Association (NYHA) Class
Time frame: Six months
Change in Quality of Life (Minnesota Living With Heart Failure Questionnaire)
Time frame: Six months
Change in Left Ventricular Ejection Fraction (LVEF)
Time frame: Six months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Edoardo G Gronda, MD, FESC principal investigator
MultiMedica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Barostim Neo System in people with Heart Failure, run by CVRx, Inc. at 1 site in Italy.
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 2 inclusion and 4 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 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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 26 Aug 2021). 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?
Changes in Sympathetic Nervous System Activity (MSNA Bursts/Min) (time frame: 6 months). The study lists 2 primary outcomes in all. 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 26 Aug 2021.