NCT07335510 Impact of Barostimulation on Hemodynamics in Adults With Heart Failure
| NCT ID | NCT07335510 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | HFrEF - Heart Failure With Reduced Ejection Fraction |
| Study Type | INTERVENTIONAL |
| Enrollment | 58 participants |
| Start Date | 2026-03-30 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 58 participants in total. It began in 2026-03-30 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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: 1. current New York Heart Association (NYHA) Class III or 2. 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 Exclusion Criteria: * 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 * 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
Contact & Investigator
Nir Uriel, MD
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT07335510 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HFrEF - Heart Failure With Reduced Ejection Fraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07335510 currently recruiting?
Yes, NCT07335510 is actively recruiting participants. Contact the research team at mds2225@cumc.columbia.edu for enrollment information.
Where is the NCT07335510 trial being conducted?
This trial is being conducted at San Francisco, United States, Washington D.C., United States, Chicago, United States, New York, United States and 3 additional locations.
Who is sponsoring the NCT07335510 clinical trial?
NCT07335510 is sponsored by Columbia University. The principal investigator is Nir Uriel, MD at Columbia University. The trial plans to enroll 58 participants.
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