eural Cardiac Therapy for Heart Failure Study

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

* Age 18 or above, or of legal age to give informed consent specific to national laws
* Willing and capable of providing informed consent
* Capable of participating in all testing associated with this clinical investigation
* Symptomatic heart failure NYHA class II or III
* Left ventricular (LV) ejection fraction <= 35% documented in patient file within the past 6 months
* Left ventricular end diastolic diameter (LVEDD) of 5.5 cm or greater documented in patient file within the past 6 months
* Prescribed to optimal pharmacologic therapy according to current local or international guidelines for treatment of acute and chronic heart failure at the time of enrollment, unless contra-indicated or not-tolerated, and on a stable dose (e.g., recommended no greater than a 100% increase or 50% decrease in dosage) for at least 30 days prior to enrollment

Exclusion Criteria

* Patients with Cardiac Resynchronization Therapy for less than one year prior to enrollment
* Patients who have been hospitalized for heart failure and who required the use of HF IV therapy within 30 days before enrollment
* Patients unable to tolerate anesthesia required for implant
* Patients with unstable angina, myocardial infarction, PTCA, coronary artery bypass graft, cerebral vascular accident, or transient ischemic attack within previous 3 months (90 days) before enrollment
* Patients whose primary cause of heart failure is mitral or aortic valve disease, with a severe classification
* Patients with persistent or permanent atrial fibrillation (AF) (according to the current local or international guidelines for the management of patients with AF at the time of enrollment) within 90 days prior to enrollment
* Pacemaker indicated patients
* Patients whose heart failure is due to congenital heart disease
* Patients who have started treatment for sleep apnea or sleep disordered breathing with therapies to maintain airway patency (e.g., CPAP, Bi-PAP, APAP) with or without oxygen supplementation within the previous 6 months prior to enrollment
* Patients with hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis)
* Patients with documented chronic obstructive lung disease, defined as forced expiratory volume at 1 sec/forced vital capacity < 60%
* Patients on or indicated for renal dialysis
* Type 1 diabetic patients
* Type 2 diabetic patients that have been treated with insulin for more than 5 years prior to enrollment
* Patients with a life expectancy of less than 12 months per physician judgment
* Patients involved in any concurrent clinical investigation (observational/governmental registries are allowed)
* Women of childbearing potential who are or might be pregnant at the time of the study (method of assessment upon physician*s discretion) or breastfeeding
* Patients with a prior cardiac transplant or expecting an heart transplant operation within the next 12 months
* Patients with a prior vagotomy
* Patients with prior or existing vagal nerve stimulation treatment
* Patients implanted with any active implantable medical device other than:
o A left sided single or dual chamber implantable cardioverter defibrillator (ICD) with bipolar sensing, or
o A left sided CRT device with each sensing channel programmed to either bipolar sensing or no sensing. All CRT patients must have had CRT for at least 1 year prior to enrollment. The total number of CRT patients will not exceed 30.
* Patients with locally implanted semi-/permanent devices such as vascular catheters, etc. that would interfere with the NECTAR-HF study system
* Patients with previously implanted devices on the right side that became infected before removal
* Patients with previous neck or upper chest surgery and resultant scar formation that interferes with the ability to implant the study system on the right side of the neck (Thyroid/parathyroid, carotid artery etc)
* Patients with known recurrent nerve paralysis
* Patients who have undergone radiotherapy for thyroid disease/cancer
* Patients who have existing or prior tracheostomy
* Patients with severe vertebral cervical disease and limited mobility in the neck; includes those that frequently wear a brace
* Patients with carotid murmur/vascular bruit/ca

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy endpoint of the study is echocardiography-determined left<br /><br>ventricular end systolic diameter (LVESD) at the 6 months follow-up visit.<br /><br>The primary safety endpoint for the study is freedom from death through the<br /><br>18-month follow-up visit. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Peak VO2 (CPET)<br /><br>Echocardiographic structural & functional (LVESV, LVEDV, LVEDD, EF)<br /><br>Quality of Life (MLHFQ and SF-36)<br /><br>NYHA Class<br /><br>Hospitalization / Mortality<br /><br>Biomarkers</p><br>