HFrEF - Heart Failure With Reduced Ejection FractionBREATHE-HFNCT07335510
Impact of Barostimulation on Hemodynamics in Adults With Heart Failure
A study testing Baroreflex Activation Therapy in people with HFrEF - Heart Failure With Reduced Ejection Fraction, run by Columbia University at 7 sites in United States.
Trial summary
This study evaluates the effects of the implantation and adjustment of the CVRx Barostim device in adult patients with heart failure with reduced ejection fraction who are receiving maximally tolerated doses of guideline directed medical and device therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HFrEF - Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Baroreflex Activation Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 7 sitesUnited States
- Study dates
- 30 Mar 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of heart failure with reduced ejection fraction (defined as ejection fraction ≤ 35% for the purposes of this study) (should be within 12 months of screen)
- Symptoms consistent with one of:
- current New York Heart Association (NYHA) Class III or
- current NYHA Class II and historical NYHA Class III
- Laboratories with last N-terminal pro-B-type natriuretic peptide (NT-proBNP) < 1600 pg/ml (should be within 3 months of screen)
- Management with maximally-tolerated GDMT medications and devices
- Age >= 18 years
Who cannot join
- Age < 18 years
- Myocardial infarction (MI), syncope, cerebrovascular accident (CVA), aborted sudden cardiac death (SCD) (and implantable cardioverter defibrillator (ICD) therapy) within 3 months of screening
- Bilateral carotid bifurcations located above the level of the mandible
- Carotid artery stenosis greater than 50% caused by atherosclerosis
- Ulcerative plaques in the carotid artery
- Baroreflex failure or autonomic neuropathy
Show all 18Show fewer
- Symptomatic un-controlled bradyarrhythmias
- Severe chronic lung disease
- Current treatment with inotropes
- Pacemaker or ICD within 3 months of screening
- Cardiac resynchronization therapy (CRT) devices within 6 months of screening or anticipated to be placed in the next 90 days following screening
- Prior surgery, radiation, endovascular stent in the carotid sinus
- History or consideration of solid organ transplantation
- History or consideration of left ventricular assist device (LVAD)
- Life expectancy <1 year from time of screening
- Non-cardiovascular conditions interfering with 6MWT distance assessment
- Inability to fulfill protocol requirements
- Known allergy to silicone or titanium
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Not yet recruiting
Medical University of South Carolina Health
Charleston, South Carolina, 29425
Ryan J. Tedford, MD, 843-792-1952, tedfordr@musc.edu
Ryan J. Tedford, MD
- Not yet recruiting
University of Chicago Medical Center
Chicago, Illinois, 15212
Manreet Kanwar, MD, 773-702-9461, manreetkanwar@uchicago.edu
Manreet Kanwar, MD
- Not yet recruiting
Weill Cornell Medicine
New York, New York, 10021
Maria Karas, MD, 646-962-5555, mgk2002@med.cornell.edu
Maria Karas, MD
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Gabriel T. Sayer, MD, 212-342-3259, gts2102@cumc.columbia.edu
Nir Uriel, MD
- Not yet recruiting
Montefiore Medical Center
New York, New York, 10461
Ulrich P. Jorde, MD, 718-920-2626, ujorde@montefiore.org
Ulrich P. Jorde, MD
- Not yet recruiting
University of California San Francisco Health
San Francisco, California, 94143
Liviu Klein, MD, 415-353-2873, liviu.klein@ucsf.edu
Liviu Klein, MD
- Not yet recruiting
MedStar Health
Washington D.C., District of Columbia, 20010
Farooq H. Sheikh, MD, 202-877-4698, farooq.h.sheikh@medstar.net
Farooq H. Sheikh, MD
About this study
Official title: Impact of Barostimulation in Cardiac Hemodynamics and Clinical Outcomes Through Use of the Barostim™ CVRx Device
This study evaluates the effects of the implantation and adjustment of the CVRx Barostim device in adult patients with heart failure with reduced ejection fraction who are receiving maximally tolerated doses of guideline directed medical and device therapies. The study aims to assess how therapy using this device affects heart function, symptoms, and exercise capacity, with particular focus on how the device affects blood flow and heart pressures during exercise. Information from this study may help inform patient selection and device management in patients with heart failure.
Read the detailed description
Heart failure with reduced ejection fraction (HFrEF) remains a major public health concern, associated with high rates of morbidity, hospitalizations, and mortality. Despite advances in medication, as well as device therapies such as implantable devices, a significant proportion of patients continue to experience debilitating symptoms, exercise intolerance, and reduced quality of life.
An important feature of HFrEF is autonomic imbalance, which contributes to disease progression and adverse outcomes. While current therapies indirectly try to affect this imbalance, the Barostim™ device (CVRx) is the first to specifically target the autonomic nervous system in this population. This device offers a novel mechanistic approach by directly stimulating the carotid baroreceptors to reduce sympathetic activity and restore autonomic balance. This prospective, multicenter study aims to evaluate the effects of the Barostim device on invasive hemodynamics through right heart catheterization (RHC), exercise capacity, and tolerance to medical therapy in HFrEF patients who remain symptomatic despite maximal guideline-directed medical therapy (GDMT). The study seeks to address key knowledge gaps in the mechanistic and clinical response to baroreflex activation therapy (BAT) and inform future integration of this therapy into standard heart failure care.
- Being tested
- Baroreflex Activation Therapy
- Keywords
- Baroreflex activation therapy, Exercise hemodynamics, Barostim, Cardiopulmonary exercise testing, Neuromodulation, Functional capacity, Heart failure with reduced ejection fraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baroreflex Activation TherapyDevice
Barostim™ device (CVRx Inc.), a commercially available, FDA-approved device for autonomic modulation in HFrEF. The device system includes an implantable pulse generator, carotid sinus lead, and programmer system. No investigational modifications will be made. The device will be implanted per standard labeling and programming guidelines, and therapy titration will follow manufacturer recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Barostim™ Therapy | Experimental | Participants will undergo implantation of the Barostim™ system, followed by device programming and titration according to standard clinical practice for up to three months after implantation. Receives: Device: Baroreflex Activation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peak exercise PCWP at 6 months post-titration
Exercise pulmonary capillary wedge pressure (PCWP) will be measured at peak exercise at approximately six months post-Barostim titration and compared with peak exercise PCWP measured during the pre-implantation phase. Change from baseline will be calculated.
Measured: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).
Secondary outcomes (18)
Change in peak exercise load-adjusted PCWP at 6 months post-titration
Exercise pulmonary capillary wedge pressure (PCWP) will be measured at peak exercise at approximately six months post-Barostim titration and compared with peak exercise PCWP measured during the pre-implantation phase. PCWP measurements will be normalized to maximal exercise load at each time point. Change from baseline will be calculated.
Measured: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).
Change in peak exercise output-adjusted PCWP at 6 months post-titration
Exercise pulmonary capillary wedge pressure (PCWP) will be measured at peak exercise at approximately six months post-Barostim titration and compared with peak exercise PCWP measured during the pre-implantation phase. PCWP measurements will be normalized to cardiac output at each time point. Change from baseline will be calculated.
Measured: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).
Change in peak exercise cardiac output at 6 months post-titration
Exercise cardiac output (CO) will be measured at peak exercise at approximately six months post-Barostim titration and compared with peak exercise CO measured during the pre-implantation phase. Change from baseline will be calculated.
Measured: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).
Proportion of participants with significant reduction in PCWP at 6 months post-titration
Exercise pulmonary capillary wedge pressure (PCWP) will be measured at peak exercise at approximately six months post-Barostim titration and compared with peak exercise PCWP measured during the pre-implantation phase. Patients will be categorized into "responders" who demonstrate either a 10% reduction in PCWP or a 3 mmHg reduction in PCWP or "non-responders" who do not demonstrate at least this degree of percent or absolute change. The proportion of participants that are considered "responders" by this metric will be collected and assessed.
Measured: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).
Change in peak exercise mean PA pressures at 6 months post-titration
Exercise mean pulmonary arterial pressure (PAP) will be measured at peak exercise at approximately six months post-Barostim titration and compared with peak exercise mean PAP measured during the pre-implantation phase. Change from baseline will be calculated.
Measured: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).
Change in peak VO2 at 6 months post-titration
Exercise peak VO2 will be measured via cardiopulmonary exercise testing (CPET) at approximately six months post-Barostim titration and compared with peak VO2 measured via CPET during the pre-implantation phase. Change from baseline will be calculated.
Measured: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).
Change in average daily step count
Average daily step counts will be measured via study-provided Fitbit Inspire 3 fitness trackers. Absolute change and trends will be assessed from baseline to monthly time points in the post-implantation phase.
Measured: Pre-implantation phase (baseline, 0-2 months) and post-implantation phase monthly (approximately 0-9 months post-implantation).
Change in average daily step count at 6 months post-titration
The most recent 30-day period of daily step counts will be measured via study-provided Fitbit Inspire 3 fitness trackers and evaluated for the average daily step count. This will be assessed at approximately six months post-Barostim titration and compared with the average of the last 30-day period of daily step counts prior to the end of the pre-implantation phase. Change from baseline will be calculated.
Measured: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).
Change in highest daily step count at 6 months post-titration
The most recent 30-day period of daily step counts will be measured via study-provided Fitbit Inspire 3 fitness trackers and evaluated for the maximum daily step count. This will be assessed at approximately six months post-Barostim titration and compared with the maximum of the last 30-day period of daily step counts prior to the end of the pre-implantation phase. Change from baseline will be calculated.
Measured: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).
Change in estimated peak VO2 at 6 months post-titration
The most recent Fitbit cardio fitness score (estimated peak VO2) will be measured via study-provided Fitbit Inspire 3 fitness trackers. This will be assessed at approximately six months post-Barostim titration and compared with the most recent Fitbit cardio fitness score prior to the end of the pre-implantation phase. Change from baseline will be calculated.
Measured: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).
Change in heart rate variability at 6 months post-titration
The most recent 30-day average of heart rate variability will be measured via study-provided Fitbit Inspire 3 fitness trackers. This will be assessed at approximately six months post-Barostim titration and compared with the average of the last 30-day period prior to the end of the pre-implantation phase. Change from baseline will be calculated.
Measured: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).
Change in proportion of exercise days per month at 6 months post-titration
The most recent 30-day proportion of exercise days will be measured via study-provided Fitbit Inspire 3 fitness trackers. This will be assessed at approximately six months post-Barostim titration and compared with the proportion of exercise days of the last 30-day period prior to the end of the pre-implantation phase. Change from baseline will be calculated.
Measured: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).
Change in six-minute walk test at 6 months post-titration
A six-minute walk test (6MWT) will be performed, and distances will be measured. This will be assessed at approximately six months post-Barostim titration and compared with the 6MWT performed during the pre-implantation phase. Change from baseline will be calculated.
Measured: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ)-12 at 6 months post-titration
The KCCQ in its 12-question version will be performed to assess quality of life, and each question has 5-7 Likert-style response options. Responses are grouped according to domain for domain-specific scores. Overall and domain-specific scores are transformed and standardized and final scores are reported from 0-100, where higher scores reflect less functional limitation and better quality of life (better outcome). This will be assessed at approximately six months post-Barostim titration and compared with the KCCQ scores obtained during the pre-implantation phase. Change from baseline will be calculated.
Measured: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).
Change in heart failure medication score at 6 months post-titration
A heart failure medication score (0-9 points) will be calculated based upon participants' current heart failure medications, with 9 indicating a better outcome. Scored are allocated in the following manner: 2 points for being on a mineralocorticoid receptor antagonist or a sodium-glucose cotransporter 2 inhibitor; 2 points for being on a heart failure-specific beta blocker (carvedilol, metoprolol succinate, or bisoprolol; 2 points for >= 50% max guideline-directed dose, 1 point for <50% dose, 0 points if not); and 3 points for being on a renin-angiotensin-aldosterone system inhibitor (3 points for an angiotensin receptor-neprilysin inhibitor, or 1-2 points for either an angiotensin-converting-enzyme inhibitor or an angiotensin receptor blocker at <50% or >=50% max guideline-directed dose). This will be assessed at approximately six months post-Barostim titration and compared with the medication scores obtained during the pre-implantation phase. Change from baseline will be calculated.
Measured: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).
Change in N-terminal prohormone of brain natriuretic peptide at 6 months post-titration
Participants' levels of N-terminal prohormone of brain natriuretic peptide (NT-proBNP) will be obtained via blood draw. This will be assessed at approximately six months post-Barostim titration and compared with the NT-proBNP levels obtained during the pre-implantation phase. Change from baseline will be calculated.
Measured: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).
Change in sleep score at 6 months post-titration
The most recent 30-day average of sleep scores will be measured via study-provided Fitbit Inspire 3 fitness trackers. This sleep score is calculated by Fitbit as a proprietary algorithm to assess sleep quality based upon time asleep, time in sleep stages, movement during sleep, and sleeping heart rate, derived from measurements obtained by the fitness tracker. It is a score graded from 0-100, with 100 being the best score. This will be assessed at approximately six months post-Barostim titration and compared with the proportion of exercise days of the last 30-day period prior to the end of the pre-implantation phase. Change from baseline will be calculated.
Measured: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).
Change in heart failure admissions at 6 months post-titration
Participants' heart failure-related hospital admission counts will be obtained for the preceding six months at each time point. This will be calculated at approximately six months post-Barostim titration and compared with the same calculation of admissions at the time of study intake. Change from baseline will be calculated.
Measured: Pre-implantation phase (baseline, approximately 0 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start30 Mar 2026
- Primary completionDec 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HFrEF - Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Model description
- This is a single-group, self-controlled study in which all enrolled participants receive the same intervention. Outcomes are evaluated within participants using pre- and post-implantation assessments following Barostim device implantation and titration.
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- CVRx, Inc.
- Responsible party
- Principal investigator, Nir Uriel, Columbia University
- Investigators
- Nir Uriel, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335510
- Sponsor's protocol ID
- AAAV9622
- Acronym
- BREATHE-HF
- Status last verified
- Jun 2026
- First submitted
- 5 Jan 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Deidentified individual participant data underlying the results reported in publications may be shared with qualified researchers upon reasonable request, following publication of the primary study results. Requests will be reviewed by the study investigators and, if approved, data will be shared under a data use agreement and in accordance with applicable institutional and regulatory requirements.
Publications
Zile MR, Lindenfeld J, Weaver FA, Zannad F, Galle E, Rogers T, Abraham WT. Baroreflex Activation Therapy in Patients With Heart Failure With Reduced Ejection Fraction. J Am Coll Cardiol. 2020 Jul 7;76(1):1-13. doi: 10.1016/j.jacc.2020.05.015.
PubMed 32616150Coats AJS, Abraham WT, Zile MR, Lindenfeld JA, Weaver FA, Fudim M, Bauersachs J, Duval S, Galle E, Zannad F. Baroreflex activation therapy with the Barostim device in patients with heart failure with reduced ejection fraction: a patient level meta-analysis of randomized controlled trials. Eur J Heart Fail. 2022 Sep;24(9):1665-1673. doi: 10.1002/ejhf.2573. Epub 2022 Jul 3.
PubMed 35713888
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Barostimulation in Cardiac Hemodynamics and Clinical Outcomes Through Use of the Barostim™ CVRx Device
- ClinicalTrials.gov ID
- NCT07335510
- Acronym / sponsor ID
- BREATHE-HF / AAAV9622
- Keywords
- Baroreflex activation therapy, Exercise hemodynamics, Barostim, Cardiopulmonary exercise testing, Neuromodulation, Functional capacity, Heart failure with reduced ejection fraction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- CVRx, Inc.
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 13 Jan 2026 (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.
This study evaluates the effects of the implantation and adjustment of the CVRx Barostim device in adult patients with heart failure with reduced ejection fraction who are receiving maximally tolerated doses of guideline directed medical and device therapies. The study aims to assess how therapy using this device affects heart function, symptoms, and exercise capacity, with particular focus on how the device affects blood flow and heart pressures during exercise. Information from this study may help inform patient selection and device management in patients with heart failure.
Detailed description
Heart failure with reduced ejection fraction (HFrEF) remains a major public health concern, associated with high rates of morbidity, hospitalizations, and mortality. Despite advances in medication, as well as device therapies such as implantable devices, a significant proportion of patients continue to experience debilitating symptoms, exercise intolerance, and reduced quality of life.
An important feature of HFrEF is autonomic imbalance, which contributes to disease progression and adverse outcomes. While current therapies indirectly try to affect this imbalance, the Barostim™ device (CVRx) is the first to specifically target the autonomic nervous system in this population. This device offers a novel mechanistic approach by directly stimulating the carotid baroreceptors to reduce sympathetic activity and restore autonomic balance. This prospective, multicenter study aims to evaluate the effects of the Barostim device on invasive hemodynamics through right heart catheterization (RHC), exercise capacity, and tolerance to medical therapy in HFrEF patients who remain symptomatic despite maximal guideline-directed medical therapy (GDMT). The study seeks to address key knowledge gaps in the mechanistic and clinical response to baroreflex activation therapy (BAT) and inform future integration of this therapy into standard heart failure care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-group, self-controlled study in which all enrolled participants receive the same intervention. Outcomes are evaluated within participants using pre- and post-implantation assessments following Barostim device implantation and titration.
| Arm | Type | Receives |
|---|---|---|
| Barostim™ Therapy | Experimental | Device: Baroreflex Activation TherapyParticipants will undergo implantation of the Barostim™ system, followed by device programming and titration according to standard clinical practice for up to three months after implantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of heart failure with reduced ejection fraction (defined as ejection fraction ≤ 35% for the purposes of this study) (should be within 12 months of screen)
- Symptoms consistent with one of:
- Laboratories with last N-terminal pro-B-type natriuretic peptide (NT-proBNP) < 1600 pg/ml (should be within 3 months of screen)
- Management with maximally-tolerated GDMT medications and devices
- Age >= 18 years
Key exclusion criteria (18 listed)
- Age < 18 years
- Myocardial infarction (MI), syncope, cerebrovascular accident (CVA), aborted sudden cardiac death (SCD) (and implantable cardioverter defibrillator (ICD) therapy) within 3 months of screening
- Bilateral carotid bifurcations located above the level of the mandible
- Carotid artery stenosis greater than 50% caused by atherosclerosis
- Ulcerative plaques in the carotid artery
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 |
|---|---|---|
| Baroreflex Activation TherapyBarostim™ device (CVRx Inc.), a commercially available, FDA-approved device for autonomic modulation in HFrEF. The device system includes an implantable pulse generator, carotid sinus lead, and programmer system. No investigational modifications will be made. The device will be implanted per standard labeling and programming guidelines, and therapy titration will follow manufacturer recommendations. | Device | Barostim™ Therapy |
Primary outcome
Change in peak exercise PCWP at 6 months post-titration
Time frame: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).
Exercise pulmonary capillary wedge pressure (PCWP) will be measured at peak exercise at approximately six months post-Barostim titration and compared with peak exercise PCWP measured during the pre-implantation phase. Change from baseline will be calculated.
18 secondary outcomes
Change in peak exercise load-adjusted PCWP at 6 months post-titration
Time frame: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).
Change in peak exercise output-adjusted PCWP at 6 months post-titration
Time frame: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).
Change in peak exercise cardiac output at 6 months post-titration
Time frame: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).
Proportion of participants with significant reduction in PCWP at 6 months post-titration
Time frame: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).
Change in peak exercise mean PA pressures at 6 months post-titration
Time frame: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).
Change in peak VO2 at 6 months post-titration
Time frame: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).
Change in average daily step count
Time frame: Pre-implantation phase (baseline, 0-2 months) and post-implantation phase monthly (approximately 0-9 months post-implantation).
Change in average daily step count at 6 months post-titration
Time frame: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).
Change in highest daily step count at 6 months post-titration
Time frame: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).
Change in estimated peak VO2 at 6 months post-titration
Time frame: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).
Change in heart rate variability at 6 months post-titration
Time frame: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).
Change in proportion of exercise days per month at 6 months post-titration
Time frame: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).
Change in six-minute walk test at 6 months post-titration
Time frame: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ)-12 at 6 months post-titration
Time frame: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).
Change in heart failure medication score at 6 months post-titration
Time frame: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).
Change in N-terminal prohormone of brain natriuretic peptide at 6 months post-titration
Time frame: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).
Change in sleep score at 6 months post-titration
Time frame: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).
Change in heart failure admissions at 6 months post-titration
Time frame: Pre-implantation phase (baseline, approximately 0 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Background: PubMed 32616150Zile MR, Lindenfeld J, Weaver FA, Zannad F, Galle E, Rogers T, Abraham WT. Baroreflex Activation Therapy in Patients With Heart Failure With Reduced Ejection Fraction. J Am Coll Cardiol. 2020 Jul 7;76(1):1-13. doi: 10.1016/j.jacc.2020.05.015.
- Background: PubMed 35713888Coats AJS, Abraham WT, Zile MR, Lindenfeld JA, Weaver FA, Fudim M, Bauersachs J, Duval S, Galle E, Zannad F. Baroreflex activation therapy with the Barostim device in patients with heart failure with reduced ejection fraction: a patient level meta-analysis of randomized controlled trials. Eur J Heart Fail. 2022 Sep;24(9):1665-1673. doi: 10.1002/ejhf.2573. Epub 2022 Jul 3.
- Summary of Safety and Effectiveness Data (SSED; FDA)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data underlying the results reported in publications may be shared with qualified researchers upon reasonable request, following publication of the primary study results. Requests will be reviewed by the study investigators and, if approved, data will be shared under a data use agreement and in accordance with applicable institutional and regulatory requirements.
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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.
Nir Uriel, MD principal investigator
Columbia University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baroreflex Activation Therapy in people with HFrEF - Heart Failure With Reduced Ejection Fraction, run by Columbia University at 7 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 7 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Morgan Smith, MD (914-629-3121, mds2225@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in peak exercise PCWP at 6 months post-titration (time frame: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).). 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 NCT07335510, which also lists 2 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 29 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.