The NECTAR-HF feasibility trial is designed to evaluate the application of right vagal nerve stimulation in heart failure patients with a New York Heart Association Class III, an ejection fraction equal to or less than 35 %, and a narrow QRS duration equal to or less than 130 ms.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Age 18 or above, and 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
* Stable symptomatic heart failure NYHA class II-III
* Left ventricular (LV) ejection fraction equal or smaller than 35 %
* Left ventricular end diastolic diameter (LVEDD) of 5.5 cm or greater
* Prescribed to optimal pharmacologic therapy
Exclusion Criteria:
* QRS larger than 130 ms
* 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 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 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…
What they're measuring
1
Change in Left Ventricular End-systolic Dimension (LVESD)
Timeframe: LVESD at Baseline and at 6-months post Baseline