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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01385176
Recruitment Status : Active, not recruiting
First Posted : June 30, 2011
Results First Posted : January 6, 2020
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heart Failure Congestive Heart Failure Device: Implant of investigational device system Procedure: Titration during the randomization phase Procedure: Titration after the randomization phase Diagnostic Test: Blood Draw Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Patients were randomized in a 2 : 1 ratio to receive therapy (VNS ON) or control (VNS OFF) for a 6-month period. The primary endpoint was the change in LVend systolic diameter (LVESD) at 6 months for control vs. therapy, with secondary endpoints of other echocardiography measurements, exercise capacity, quality-of-life assessments, 24-h Holter, and circulating biomarkers.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neural Cardiac Therapy for Heart Failure Study
Actual Study Start Date : September 21, 2011
Actual Primary Completion Date : May 2014
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Therapy

Implant of investigational device system for vagus nerve stimulation. Patients were randomized in a 2 : 1 ratio to receive therapy (VNS ON) or control (VNS OFF) for a 6-month period.

The experimental arm was receiving vagus nerve stimulation during the first 6 months after implant.

Titration during the randomization phase with delivery of highest tolerable by patient stimulation current.

Blood Draw before implant and 6 months after implant. Titration after the randomization phase with adjustments of the chronically highest tolearble by patient current.

Device: Implant of investigational device system
Vagus nerve stimulation lead was wrapped around the right cervical vagus nerve and then connected to a stimulator permanently implanted in the right pectoral region.

Procedure: Titration during the randomization phase
Amplitude of the chronically delivered vagus nerve stimulation in the experimental arm was adjusted to the highest tolerable by patient value. No chronically delivered vagus nerve stimulation in the control arm during the randomization phase.

Procedure: Titration after the randomization phase
Amplitude of the chronically delivered vagus nerve stimulation was adjusted to the highest tolerable by patient value in all patients in both arms of the study.

Diagnostic Test: Blood Draw
Blood draw before implant and 6 months after implant at the end of the randomization phase.

Sham Comparator: Control

Implant of investigational device system for vagus nerve stimulation. Control group was implanted with study system like the experimental arm, but was not receiving experimental vagus nerve stimulation therapy during the first 6 months after implant. 6-month after implant a cross-over took place and the control arm also started to receive experimental vagus nerve stimulation.

Blood Draw before implant and 6 months after implant. Titration after the randomization phase with adjustments of the chronically highest tolearble by patient current.

Device: Implant of investigational device system
Vagus nerve stimulation lead was wrapped around the right cervical vagus nerve and then connected to a stimulator permanently implanted in the right pectoral region.

Procedure: Titration after the randomization phase
Amplitude of the chronically delivered vagus nerve stimulation was adjusted to the highest tolerable by patient value in all patients in both arms of the study.

Diagnostic Test: Blood Draw
Blood draw before implant and 6 months after implant at the end of the randomization phase.




Primary Outcome Measures :
  1. Change in Left Ventricular End-systolic Dimension (LVESD) [ Time Frame: LVESD at Baseline and at 6-months post Baseline ]

    Change in the Left ventricular end-systolic dimension (LVESD) between Baseline and the value at the end of the randomization phase (6 months after Baseline) i.e. 6 months after vagus nerve stimulation in the THERAPY Arm. No Vagus nerve stimulation during that time window in the CONTROL Arm.

    The sign (- ) indicates a reduction in the LVESD. Minus means a reduction in LVESD.

    The change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline).


  2. Percentage of Surviving Participants [ Time Frame: 18-months ]
    As pre-specified in the study protocol, the All-cause Survival endpoint combined both groups into one analysis population. Subjects contributed data according to the follow-up period during they received VNS therapy (Implant through 18 months for Therapy subjects, 6 through 18 months for Control subjects). Control patients who exited the study in the first 6 months, or who did not have a 6 month visit, were excluded.


Secondary Outcome Measures :
  1. LVEF, Left Ventricular Ejection Fraction [ Time Frame: LVEF at Baseline and at 6-months after Baseline ]
    LVEF, left ventricular ejection fraction.

  2. Exercise Capacity, Peak VO2 [ Time Frame: Measurements at Baseline and at 6-months after Baseline ]
    Assessment of functional capacity (e.g., peak VO2) as measures related to patient heart failure status.

  3. LVESV, Left Ventricular End Systolic Volume [ Time Frame: At Baseline and at 6-months after Baseline ]
    Measurements of LVESV, left ventricular end systolic volume at Baseline and 6 months after Baseline in the Control Arm and in the Therapy Arm



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01385176


Locations
Show Show 21 study locations
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Faiez Zannad, M.D. Centre d'Investigation Clinique (CIC), Batiment Louis Mathieu, CHU de Nancy
Publications of Results:
Other Publications:
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01385176    
Other Study ID Numbers: NECTAR-1109
First Posted: June 30, 2011    Key Record Dates
Results First Posted: January 6, 2020
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Boston Scientific Corporation:
Heart failure
Congestive heart failure
New York Heart Association Class II-III
Vagal therapy
Vagal nerve stimulation
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases