NL-OMON38346
Withdrawn
Not Applicable
eo Randomized Heart Failure Study - Neo HF
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- heartfailure
- Sponsor
- CVRx Inc
- Enrollment
- 20
- Status
- Withdrawn
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Age at least 21 years ;2\.Bilateral carotid bifurcations that are easily interrogated by carotid duplex ultrasound and are below the level of the mandible. ;3\.No ulcerative carotid arterial plaques or carotid atherosclerosis producing a 50% or greater reduction in linear diameter in the internal or the distal common carotid, as determined within 45 days prior to randomization. ;4\.Left ventricular ejection fraction \<\= 35% within 45 days prior to randomization. ;5\.NYHA Class III within 45 days prior to randomization. ;6\.Have a six\-minute hall walk test performance: 150m \<\= 6MW \<\= 450m within 45 days prior to randomization. ;7\.On optimal, stable pharmacological therapy for at least 4 weeks prior to obtaining the baseline echocardiographic measurement, where optimal and stable are defined as follows:
- •Optimal pharmacological therapy: Prescribed to a beta blocker, a diuretic, and an ACE inhibitor or ARB 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. ;8\.Not currently being treated with dialysis. ;9\.Heart rate is between 60 and 110 b/min via a clinic measurement. ;10\. If female and of childbearing potential, must use a medically accepted method of birth control (e.g., barrier method with spermicide, oral contraceptive, or abstinence) and agree to continue use of this method for the duration of the study. Women of childbearing potential must have a negative pregnancy test within 14 days prior to randomization. ;11\. An appropriate surgical candidate. ;12\. Signed a CVRx\-approved informed consent form for participation in this study.
Exclusion Criteria
- •1\. Known or suspected baroreflex failure or autonomic neuropathy.
- •2\. Body mass index of greater than 40\.
- •3\. Significant uncontrolled symptomatic bradyarrhythmias.
- •4\. If the subject has recently received a pacemaker or an ICD implant, the subject may not be implanted until at least 90 days after the implant procedure. Patients with a CRT(D) implant may not be randomized untill 6 months after the activation of CRT therapy.
- •5\. Solid organ or hematologic transplant.
- •6\. Episode of NYHA class IV heart failure with acute pulmonary edema within 30 days prior to implant.
- •7\. Myocardial infarction, unstable angina, syncope, cerebral vascular accident, SCD, or received defibrillation therapy within the 3 months prior to implant.
- •8\. Prior surgery, radiation, or endovascular stent placement in the carotid sinus region, limiting the ability to place the carotid sinus lead.
- •9\. Heart failure secondary to a reversible or treatable condition such as, cardiac structural valvular disease, acute myocarditis and pericardial constriction.
- •10\. Heart failure secondary to right ventricular failure or right ventricular myocardial infarction.
Outcomes
Primary Outcomes
Not specified
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