Heart FailureNCT04502316
Real-World Experience - Barostim™ Advancing the Level of Clinical Evidence (REBALANCE Registry)
An observational study of Heart Failure, run by CVRx, Inc. at 46 sites in United States.
Trial summary
The purpose of this registry is to develop valid scientific evidence of the safety and benefit of Barostim Therapy in the commercial setting in patients with heart failure with reduced ejection fraction (HFrEF) that were recently implanted with the Barostim System. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- What is being tested?
- Barostim™ System
- Type of treatment
- Medical device
- How many people
- 435 participants
- Where
- 46 sitesUnited States
- Study dates
- 26 Jun 2020to 30 Jun 2026
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients can be included in the registry if they were implanted with a de novo Barostim System.
Who may be able to join
- Patients can be included in the registry if they were implanted with a de novo Barostim System. Patients must sign an informed consent form after implantation with the Barostim System in order to participate in the registry.
- Indications:
- The Barostim System is indicated for the improvement of symptoms of heart failure - quality of life, six-minute hall walk and functional status - for patients who remain symptomatic despite treatment with guideline-directed medical therapy, are NYHA Class III or Class II (who had a recent history of Class III), have a left ventricular ejection fraction ≤ 35%, a NT-proBNP < 1600 pg/ml and excluding patients indicated for Cardiac Resynchronization Therapy (CRT) according to AHA/ACC/ESC guidelines.
- Contraindications:
- Bilateral carotid bifurcations located above the level of the mandible
- Baroreflex failure or autonomic neuropathy
Show all 10Show fewer
- Uncontrolled, symptomatic cardiac bradyarrhythmias
- Carotid atherosclerosis that is determined by ultrasound or angiographic evaluation greater than 50%
- Ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation
- Known allergy to silicone or titanium
Who cannot join
None listed.
Trial locations and contacts
46 sites in 1 country.
46 sites in 1 country
United States46 sites
Capital Cardiology
Albany, New York, 12211
Orlando Cardiac & Vascular Specialists
Altamonte Springs, Florida, 32701
Orlando Heart and Vascular Institute
Altamonte Springs, Florida, 32714
Aurora Denver Cardiology Associates
Aurora, Colorado, 80012
Austin Heart
Austin, Texas, 78756
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Grandview Medical Center
Birmingham, Alabama, 35243
Lakewood Cardiovascular
Bradenton, Florida, 34202
AMA Heart and Vascular
Bradenton, Florida, 34208
Cardiovascular Solutions Institute
Bradenton, Florida, 34209
Cardiac Care Group
Cape Coral, Florida, 33914
University of Chicago
Chicago, Illinois, 60637
Baylor Scott & White Research Institute
Dallas, Texas, 75246
Daytona Heart Group
Daytona Beach, Florida, 32114
Florida Heart Rhythm Specialists
Fort Lauderdale, Florida, 33308
Stern Cardiovascular
Germantown, Tennessee, 38138
DeGregorio Cardiology
Glen Ridge, New Jersey, 07028
Cone Health
Greensboro, North Carolina, 27401
HeartPlus Diagnostic Center
Jackson, Mississippi, 39296
First Coast Cardiovascular Institute
Jacksonville, Florida, 32256
Marian David, M.D., P.C
Kew Gardens, New York, 11415
Capitol Cardiology Associates
Lanham, Maryland, 20706
South Denver Cardiology Associates, P.C.
Littleton, Colorado, 80120
Centra Heart & Vascular Institute
Lynchburg, Virginia, 24501
Premier Cardiology & Vascular Associates
Maitland, Florida, 32751
Carient Heart & Vascular
Manassas, Virginia, 20109
Adam Budzikowski PC
Maspeth, New York, 11378
Chan Heart Rhythm Institute
Mesa, Arizona, 85206
University of Miami
Miami, Florida, 33136
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Cardiovascular Medicine
Moline, Illinois, 61265
Naples Heart Rhythm Specialists, PA
Naples, Florida, 34119
AdventHealth Orlando
Orlando, Florida, 32803
Cabrillo Cardiology Research Group
Oxnard, California, 93030
Advanced Cardiac Care
Ozone Park, New York, 11416
Akil Loli Consulting LLC
Phoenix, Arizona, 85016
Valley Hospital
Ridgewood, New Jersey, 07450
Sarasota Memorial Research Institute (Sarasota Memorial Hospital)
Sarasota, Florida, 34239
Cardio Vascular Health Associates
South River, New Jersey, 08882
University of South Florida
Tampa, Florida, 33609
COR Healthcare Medical Associates
Torrance, California, 90505
Howard T. Tee, M.D., F.A.C.C., F.A.C.P.
Vero Beach, Florida, 32960
Medstar Health Research Insitutute
Washington D.C., District of Columbia, 20010
The George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, 20037
Marshfield Medical Center - Weston
Weston, Wisconsin, 54479
Florida Cardiology (Guardian Research Organization, LLC)
Winter Park, Florida, 32792
About this study
Official title: Real-World Experience -- Barostim™ Advancing the Level of Clinical Evidence (REBALANCE Registry) A Post-Market Registry With the Barostim™ System
The purpose of this registry is to develop valid scientific evidence of the safety and benefit of Barostim Therapy in the commercial setting in patients with heart failure with reduced ejection fraction (HFrEF) that were recently implanted with the Barostim System.
Read the detailed description
Summary:
The CVRx REBALANCE Registry includes patients who have been implanted with the Barostim System. Up to 5,000 patients will be enrolled. Data should be obtained from evaluations taken prior to implant, at implant, and every six months after device implant, up to the 36-month visit at which time each patient will be exited from the registry.
Enrollment data are collected retrospectively after consent and Barostim implant; post-enrollment data are collected prospectively from standard of care follow-up.
- Conditions
- Heart Failure
- Being tested
- Barostim™ 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™ SystemDevice
Implantation of the Barostim™ System
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this post-market registry is to develop valid scientific evidence of the safety and benefit of Barostim Therapy in the commercial setting in patients that were recently implanted with the Barostim System.
Measured: 36 months post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start26 Jun 2020
- Primary completion14 May 2026
- Study completion30 Jun 2026
Why it stopped: Participant follow-up through 12 months post-Barostim Implant sufficient for data collection and analysis purposes.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 435 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
- NCT04502316
- Sponsor's protocol ID
- 360059-001
- Status last verified
- Sep 2026
- First submitted
- 30 Jul 2020
- Last updated
- 17 Sep 2026
- Results posted
- No
- 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 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Experience -- Barostim™ Advancing the Level of Clinical Evidence (REBALANCE Registry) A Post-Market Registry With the Barostim™ System
- ClinicalTrials.gov ID
- NCT04502316
- Acronym / sponsor ID
- 360059-001
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Participant follow-up through 12 months post-Barostim Implant sufficient for data collection and analysis purposes.
- Enrolment
- 435 participants (actual)
- Lead sponsor
- CVRx, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Jun 2020 (actual)
- Primary completion
- 14 May 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 6 Aug 2020 (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 purpose of this registry is to develop valid scientific evidence of the safety and benefit of Barostim Therapy in the commercial setting in patients with heart failure with reduced ejection fraction (HFrEF) that were recently implanted with the Barostim System.
Detailed description
Summary:
The CVRx REBALANCE Registry includes patients who have been implanted with the Barostim System. Up to 5,000 patients will be enrolled. Data should be obtained from evaluations taken prior to implant, at implant, and every six months after device implant, up to the 36-month visit at which time each patient will be exited from the registry.
Enrollment data are collected retrospectively after consent and Barostim implant; post-enrollment data are collected prospectively from standard of care follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients can be included in the registry if they were implanted with a de novo Barostim System.
Key inclusion criteria (10 listed)
- Patients can be included in the registry if they were implanted with a de novo Barostim System. Patients must sign an informed consent form after implantation with the Barostim System in order to participate in the registry.
- The Barostim System is indicated for the improvement of symptoms of heart failure - quality of life, six-minute hall walk and functional status - for patients who remain symptomatic despite treatment with guideline-directed medical therapy, are NYHA Class III or Class II (who had a recent history of Class III), have a left ventricular ejection fraction ≤ 35%, a NT-proBNP < 1600 pg/ml and excluding patients indicated for Cardiac Resynchronization Therapy (CRT) according to AHA/ACC/ESC guidelines.
- Bilateral carotid bifurcations located above the level of the mandible
- Baroreflex failure or autonomic neuropathy
- Uncontrolled, symptomatic cardiac bradyarrhythmias
Key exclusion criteria (0 listed)
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™ SystemImplantation of the Barostim™ System | Device | – |
Primary outcome
The primary objective of this post-market registry is to develop valid scientific evidence of the safety and benefit of Barostim Therapy in the commercial setting in patients that were recently implanted with the Barostim System.
Time frame: 36 months post-implant
Results and safety
The study was stopped early (reason given: Participant follow-up through 12 months post-Barostim Implant sufficient for data collection and analysis purposes.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
46 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by CVRx, Inc. at 46 sites in United States.
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 10 inclusion and 0 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 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States. 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?
The study was stopped early (reason given: Participant follow-up through 12 months post-Barostim Implant sufficient for data collection and analysis purposes.). 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 primary objective of this post-market registry is to develop valid scientific evidence of the safety and benefit of Barostim Therapy in the commercial setting in patients that were recently implanted with the Barostim System. (time frame: 36 months post-implant). 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 17 Sep 2026.