Heart FailureNCT01471860
BAROSTIM NEO System in the Treatment of Heart Failure
A study testing BAROSTIM NEO System and Medical Management in people with Heart Failure, run by CVRx, Inc. at 30 sites in 4 countries.
Trial summary
The purpose of this portion of study NCT01471860 is to assess the long-term safety and efficacy of the BAROSTIM NEO System in Canadian study participants implanted with the device. 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 and Medical Management
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 30 sitesin 4 countries
- Study dates
- Aug 2011to 11 Aug 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Actively participating in the Neo Randomized Heart Failure Study.
- Have signed a revised approved informed consent form for continued participation in this study.
Who cannot join
- Treating physician decision that the subject should not continue with therapy.
Trial locations and contacts
30 sites in 4 countries.
30 sites in 4 countries
Germany17 sites
Vivantes Hospital Berlin
Berlin, 10967
Immanuel Hospital Bernau-Heart Center Brandenburg
Bernau, 16321
University Hospital Cologne
Cologne, 50937
University Hospital Essen
Essen, 45122
CVC Frankfurt
Frankfurt, 60389
University Hospital Giessen
Giessen, 35392
Georg August University - Goettingen
Göttingen, 37075
Klinik St. Georg, Hamburg
Hamburg, 20099
University Heart Center Hamburg
Hamburg, 20246
Medizinische Hochschule Hannover
Hanover, 30625
University Hospital of Schleswig-Holstein, Kiel Campus
Kiel, 24105
Klinikum St. Georg Leipzig
Leipzig, 04129
Klinikum Ludenscheid
Lüdenscheid, 58515
University Hospital Mannheim
Mannheim, 68167
Lukas Hospital Neuss
Neuss, 41464
Oldenburg Hospital
Oldenburg, 26133
Reinbek Hospital, St. Adolf-Stift
Reinbek, 21465
Canada5 sites
University of Calgary
Calgary, Alberta, T2N 4Z6
University of Alberta - Edmonton
Edmonton, Alberta, T6G 2B7
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
University of British Columbia
Vancouver, British Columbia, V6Z 1Y6
St. Boniface Hospital
Winnipeg, Manitoba, R2H 2A6
Italy5 sites
Azienda Ospedaliero Universitaria Opedali
Ancona, 60126
Azienda Ospedaliera Spedali Riuniti Di Bergamo
Bergamo, 24128
Azienda Ospedaliero - Universitaria Careggi
Florence, 50134
Istituto Scientifico San Luca
Milan, 20149
Istituto Clinico Humanitas
Rozzano, Milano, 20089
France3 sites
CHRU de Lille
Lille, 590347
CHU de Rennes
Rennes, 35033
CHU de Toulouse
Toulouse, 31073
About this study
Official title: Neo Randomized Heart Failure Study
The purpose of this portion of study NCT01471860 is to assess the long-term safety and efficacy of the BAROSTIM NEO System in Canadian study participants implanted with the device.
Read the detailed description
The Neo Randomized Heart Failure Study is a prospective, randomized, study describing the safety and efficacy of the BAROSTIM NEO System in the heart failure participants with a left ventricular ejection fraction ≤ 35%.
During long-term follow-up, all participants are required to have at least one annual visit.
Parameters assessed during long-term follow-up visits:
- Physical Assessment
- Subject Medications
- Serious adverse events
- Conditions
- Heart Failure
- Being tested
- BAROSTIM NEO System, Medical Management
- 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
Medical ManagementDrug
| Study group | Role | What they receive |
|---|---|---|
| Device and Medical Management | Experimental | Medical Management, to be determined by the participant's physician, described as:
* Optimal pharmacological therapy: Prescribed to a beta blocker, a diuretic, and an ACE (Angiotensin-converting-enzyme) inhibitor or ARB (Angiotensin Receptor Blocker) unless contraindicated or not tolerated. These drugs must be used in a manner consistent with their labeling.
* Stable pharmacological therapy: No more than a 50% increase or a 50% decrease of the dosage of any one medication, and post titration of all heart failure medications.
Participants should remain on their prescribed heart failure medications and same dosing schedule for the duration of the study unless investigators determine medically necessary changes are needed. Additionally, every effort should be made to maintain adequate rate control for subjects with atrial fibrillation throughout the duration of the study. Receives: Device: BAROSTIM NEO System; Drug: Medical Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess long-term adverse events in Canadian participants implanted with the BAROSTIM NEO System
Ascertain the type, frequency, severity and timing of long-term adverse events in participants implanted with the device, while providing a viable treatment option to participants currently implanted with the BAROSTIM NEO System.
Measured: For the duration of the study, up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startAug 2011
- Primary completionSep 2014
- Study completion11 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- CVRx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Uta Hoppe, MD, Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471860
- Sponsor's protocol ID
- 360029
- Status last verified
- Oct 2019
- First submitted
- 9 Nov 2011
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Abraham WT, Zile MR, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Muller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Little WC. Baroreflex Activation Therapy for the Treatment of Heart Failure With a Reduced Ejection Fraction. JACC Heart Fail. 2015 Jun;3(6):487-496. doi: 10.1016/j.jchf.2015.02.006. Epub 2015 May 14.
PubMed 25982108Halbach M, Abraham WT, Butter C, Ducharme A, Klug D, Little WC, Reuter H, Schafer JE, Senni M, Swarup V, Wachter R, Weaver FA, Wilks SJ, Zile MR, Muller-Ehmsen J. Baroreflex activation therapy for the treatment of heart failure with reduced ejection fraction in patients with and without coronary artery disease. Int J Cardiol. 2018 Sep 1;266:187-192. doi: 10.1016/j.ijcard.2018.04.075. Epub 2018 Apr 21.
PubMed 29705650Zile MR, Abraham WT, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Muller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Little WC. Baroreflex activation therapy for the treatment of heart failure with a reduced ejection fraction: safety and efficacy in patients with and without cardiac resynchronization therapy. Eur J Heart Fail. 2015 Oct;17(10):1066-74. doi: 10.1002/ejhf.299. Epub 2015 Jun 10.
PubMed 26011593
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neo Randomized Heart Failure Study
- ClinicalTrials.gov ID
- NCT01471860
- Acronym / sponsor ID
- 360029
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (actual)
- Lead sponsor
- CVRx, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2011 (actual)
- Primary completion
- Sep 2014 (actual)
- Study completion
- 11 Aug 2021 (estimated)
- First posted
- 16 Nov 2011 (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 purpose of this portion of study NCT01471860 is to assess the long-term safety and efficacy of the BAROSTIM NEO System in Canadian study participants implanted with the device.
Detailed description
The Neo Randomized Heart Failure Study is a prospective, randomized, study describing the safety and efficacy of the BAROSTIM NEO System in the heart failure participants with a left ventricular ejection fraction ≤ 35%.
During long-term follow-up, all participants are required to have at least one annual visit.
Parameters assessed during long-term follow-up visits:
- Physical Assessment
- Subject Medications
- Serious adverse events
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device and Medical Management | Experimental | Device: BAROSTIM NEO System, Drug: Medical ManagementMedical Management, to be determined by the participant's physician, described as: * Optimal pharmacological therapy: Prescribed to a beta blocker, a diuretic, and an ACE (Angiotensin-converting-enzyme) inhibitor or ARB (Angiotensin Receptor Blocker) unless contraindicated or not tolerated. These drugs must be used in a manner consistent with their labeling. * Stable pharmacological therapy: No more than a 50% increase or a 50% decrease of the dosage of any one medication, and post titration of all heart failure medications. Participants should remain on their prescribed heart failure medications and same dosing schedule for the duration of the study unless investigators determine medically necessary changes are needed. Additionally, every effort should be made to maintain adequate rate control for subjects with atrial fibrillation throughout the duration of the study. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Actively participating in the Neo Randomized Heart Failure Study.
- Have signed a revised approved informed consent form for continued participation in this study.
Key exclusion criteria (1 listed)
- Treating physician decision that the subject should not continue with therapy.
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 System | Device | Device and Medical Management |
| Medical Management | Drug | Device and Medical Management |
Primary outcome
To assess long-term adverse events in Canadian participants implanted with the BAROSTIM NEO System
Time frame: For the duration of the study, up to 5 years.
Ascertain the type, frequency, severity and timing of long-term adverse events in participants implanted with the device, while providing a viable treatment option to participants currently implanted with the BAROSTIM NEO System.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
- Results publication: PubMed 25982108Abraham WT, Zile MR, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Muller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Little WC. Baroreflex Activation Therapy for the Treatment of Heart Failure With a Reduced Ejection Fraction. JACC Heart Fail. 2015 Jun;3(6):487-496. doi: 10.1016/j.jchf.2015.02.006. Epub 2015 May 14.
- Derived from this study: PubMed 29705650Halbach M, Abraham WT, Butter C, Ducharme A, Klug D, Little WC, Reuter H, Schafer JE, Senni M, Swarup V, Wachter R, Weaver FA, Wilks SJ, Zile MR, Muller-Ehmsen J. Baroreflex activation therapy for the treatment of heart failure with reduced ejection fraction in patients with and without coronary artery disease. Int J Cardiol. 2018 Sep 1;266:187-192. doi: 10.1016/j.ijcard.2018.04.075. Epub 2018 Apr 21.
- Derived from this study: PubMed 26011593Zile MR, Abraham WT, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Muller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Little WC. Baroreflex activation therapy for the treatment of heart failure with a reduced ejection fraction: safety and efficacy in patients with and without cardiac resynchronization therapy. Eur J Heart Fail. 2015 Oct;17(10):1066-74. doi: 10.1002/ejhf.299. Epub 2015 Jun 10.
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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.
Uta Hoppe, MD principal investigator
University of Cologne
30 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BAROSTIM NEO System and Medical Management in people with Heart Failure, run by CVRx, Inc. at 30 sites in 4 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 2 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 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Germany, Canada, Italy, 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. 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?
To assess long-term adverse events in Canadian participants implanted with the BAROSTIM NEO System (time frame: For the duration of the study, up to 5 years.). 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 NCT01471860, which also lists 3 linked publications.
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 4 Nov 2019.