N/A
Completed N=11
Baroreflex Activation Therapy in Heart Failure
Source: ClinicalTrials.gov NCT01484288 ↗Enrolled (actual)
11
Serious AEs
63.6%
Results posted
Aug 2021
Primary outcomePrimary: Changes in Sympathetic Nervous System Activity (MSNA Bursts/Min) — -13.8 bursts/min
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Sympathetic Nervous System Activity (MSNA Bursts/Min) |
-13.8 | — |
| PRIMARY Changes in Sympathetic Nervous System Activity (MSNA Bursts/100 Heartbeats) |
-22.5 | — |
| SECONDARY Change in Systolic Blood Pressure |
0.2 | — |
| SECONDARY Change in Diastolic Blood Pressure |
-2.3 | — |
| SECONDARY Change in Heart Rate |
-0.2 | — |
| SECONDARY Change in Six-Minute Hall Walk |
51.1 | — |
| SECONDARY New York Heart Association (NYHA) Class |
9; 1; 0; 0 | — |
| SECONDARY Change in Quality of Life (Minnesota Living With Heart Failure Questionnaire) |
-10.6 | — |
| SECONDARY Change in Left Ventricular Ejection Fraction (LVEF) |
0.8 | — |
Eligibility Criteria
Inclusion Criteria
- Age at least 21 years
- Symptomatic heart failure despite optimal, stable pharmacological therapy for at least 4 weeks
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01484288). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.