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Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)
Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)

NCT01385176

Active Not RecruitingNA

Sponsor: Boston Scientific Corporation

Conditions: Heart Failure, Congestive Heart Failure

Interventions: Implant of investigational device system, Titration during the randomization phase, Titration after the randomization phase, Blood Draw

Countries: Belgium, Czechia, France, Germany, Italy, Netherlands, Spain, United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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 cardiomyopathy or infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis)
* Patients with documented chronic obstructive lung disease
* 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
* Women of childbearing potential who are or might be pregnant at the time of the study or breastfeeding
* Patients with a prior cardiac transplant or expecting a 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 a left sided single or dual chamber implantable cardioverter defibrillator (ICD) with bipolar sensing, or 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 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 tracheotomy
* 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/carotid artery lesion
* Patients with known/suspected vascular malformation in carotid/vertebral circulatory bed
* Patients who are likely to need an MRI of the neck area because of previous medical conditions
Locations (21)
  • Brussels, Belgium
  • Prague, Czechia
  • Vandœuvre-lès-Nancy, Nancy, France
  • Lille, France
  • Bernau bei Berlin, Brandenburg, Germany
  • Göttingen, Germany
  • Hamburg, Germany
  • Leipzig, Germany
  • Milan, Italy
  • Naples, Italy
  • Pavia, Italy
  • Eindhoven, Netherlands
  • Utrecht, Netherlands
  • Pamplona, Navarre, Spain
  • Barcelona, Spain
  • Madrid, Spain
  • Bristol, England, United Kingdom
  • Liverpool, England, United Kingdom
  • London, England, United Kingdom
  • London, England, United Kingdom
  • London, United Kingdom