eo Randomized Heart Failure Study

Withdrawn

Conditions: heartfailure
decompensatio cordis
10019280

Registration Number: NL-OMON38346

Lead Sponsor: CVRx Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 20

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.
11. Primary cardiomyopathy or infiltrative heart disease.
12. Asthma, severe COPD (e.g. FEV1<1.5 liter), or severe restrictive lung disease.
13. Non-cardiovascular condition limiting the ability to assess the six-minute hall walk test.
14. Co-morbid medical condition that would adversely affect participation in the study.
15. Life expectancy less than one year.
16. Clinically significant psychological condition that in the physician's opinion would prohibit the subject's ability to meet the protocol requirements.
17. Unable or unwilling to fulfill the protocol medication compliance, testing, and follow-up requirements.
18. Enrolled in another concurrent clinical trial, without prior approval of CVRx.
19. Known allergy to silicone or titanium.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>3.1.1 Primary Efficacy Objective<br /><br>To determine whether Baroreflex Activation Therapy with the Neo system produces<br /><br>a change in Left Ventricular Ejection Fraction (LVEF) from screening through 6<br /><br>months of follow-up for subjects treated with Neo therapy relative to standard<br /><br>of care.<br /><br>3.1.2 Primary Safety Objective<br /><br>To describe the safety of Baroreflex Activation Therapy utilizing the Neo<br /><br>system by estimating the rate of all system- and procedure-related<br /><br>complications through the 6-month visit.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The following secondary endpoints will be compared between the randomized<br /><br>groups:<br /><br>1. Six-Minute Hall Walk<br /><br>2. NYHA Classification<br /><br>3. Quality of Life, as measured by the Minnesota Living With Heart Failure<br /><br>Questionnaire<br /><br>4. NT-pro BNP<br /><br>5. Creatinine<br /><br>6. Central pressure and hemodynamic parameters<br /><br>7. Electrocardiographic parameters and indices of rhythm status derived from<br /><br>24-hour Holter recordings<br /><br>8. Additional echocardiographic parameters.</p><br>