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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01385176
First received: June 28, 2011
Last updated: December 19, 2013
Last verified: December 2013

June 28, 2011
December 19, 2013
June 2011
January 2014   (final data collection date for primary outcome measure)
  • Left ventricular end-systolic dimension (LVESD) [ Time Frame: 6-months post-implant ] [ Designated as safety issue: No ]
    Echocardiography LVESD
  • All-cause mortality [ Time Frame: 18-months post-implant ] [ Designated as safety issue: Yes ]
    All-cause mortality
Same as current
Complete list of historical versions of study NCT01385176 on ClinicalTrials.gov Archive Site
  • Left ventricular remodeling [ Time Frame: 6-months post-implant ] [ Designated as safety issue: No ]
    Echocardiography parameters of left ventricular structure and function (e.g., LVEF, LVESV and LVEDV, LVEDD)
  • Functional capacity [ Time Frame: 6-months post-implant ] [ Designated as safety issue: No ]
    Assessment of functional capacity (e.g., peak VO2, anaerobic threshold)
  • Quality of Life [ Time Frame: 6-months post-implant ] [ Designated as safety issue: No ]
    Assessments of patient reported quality of life (i.e., MLWHFQ and SF-36)
  • Heart failure status [ Time Frame: 6-months post-implant ] [ Designated as safety issue: No ]
    Assessment of heart failure status (i.e., NYHA Class)
Same as current
Not Provided
Not Provided
 
Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)
Neural Cardiac Therapy for Heart Failure Study

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.

The objectives of this study are to assess the impact of right vagal nerve stimulation on left ventricular remodeling, functional capacity, quality of life, and other measures in heart failure patients over a 6-month period. In addition, the study will assess the safety of the NECTAR-HF study system over an 18-month period.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Heart Failure
  • Congestive Heart Failure
Device: Vagal Nerve Stimulation
Patients randomized to therapy arm with receive right vagal nerve stimulation. Patients randomized to control arm will not receive right vagal nerve stimulation for the first 6-months post-implant, after which they will also receive therapy.
  • Experimental: Therapy
    Intervention: Device: Vagal Nerve Stimulation
  • No Intervention: Control
    Control group will be implanted with study system, but will receive no therapy until 6-month cross-over.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
250
January 2015
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Czech Republic,   France,   Germany,   Italy,   Netherlands,   Spain,   United Kingdom
 
NCT01385176
NECTAR-1109
Yes
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Principal Investigator: Faiez Zannad, M.D. Centre d'Investigation Clinique (CIC), Batiment Louis Mathieu, CHU de Nancy
Boston Scientific Corporation
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP