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
  Purpose

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 Intervention Phase
Heart Failure
Congestive Heart Failure
Device: Vagal Nerve Stimulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neural Cardiac Therapy for Heart Failure Study

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 250
Study Start Date: June 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Therapy 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.
No Intervention: Control
Control group will be implanted with study system, but will receive no therapy until 6-month cross-over.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01385176

Locations
Belgium
UCL Bruxelles
Brussels, Belgium, 1200
Czech Republic
Nemocnice Na Homolce
Prague, Czech Republic, 15030
France
Centre d'Investigation Clinique Pierre Drouin, CHU de Nancy
Vandoeuvre les Nancy, Nancy, France, 54500
CHRU de Lille - Hôpital Cardiologique
Lille, France, 59037
Pitié Salpétrière
Paris, France, 75013
Germany
Immanuel Klinikum Bernau Herzzentrum Brandenburg
Bernau, Brandenburg, Germany, 16321
Universitätsmedizin Göttingen
Göttingen, Germany, 37075
Universitäres Herzzentrum GmbH, Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Universitätsklinikum Leipzig
Leipzig, Germany, 04103
Universitätsklinikum Rostock
Rostock, Germany, 18057
Italy
Azienda Ospedaliera Niguarda Cà Granda
Milano, Italy, 20162
A. O. Dei Colli - Monaldi
Napoli, Italy, 80131
Policlinico San Matteo
Pavia, Italy, 27100
Netherlands
Catharina Ziekenhuis Eindhoven
Eindhoven, Netherlands, 5623EJ
UMC Utrecht
Utrecht, Netherlands, 3584CX
Spain
Hospital Doce de Octubre
Madird, Madrid, Spain, 28041
Hospital Puerta de Hierro
Majadahonda, Madrid, Spain, 28222
Clínica Universitaria de Navarra, Avenida Pio XII s/n
Pamplona, Navarra, Spain, 31008
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
United Kingdom
University Hospitals Bristol, NHS Foundation Trust
Bristol, England, United Kingdom, BS2 8HW
Liverpool Heart and Chest Hospital, NHS Foundation Trust
Liverpool, England, United Kingdom, L14 3PD
The Heart Hospital, University College London Hospitals, NHS Foundation Trust
London, England, United Kingdom, W1G 8PH
Imperial College Healthcare NHS Trust, St. Mary's Hospital
London, England, United Kingdom, W2 1NY
King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Faiez Zannad, M.D. Centre d'Investigation Clinique (CIC), Batiment Louis Mathieu, CHU de Nancy
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01385176     History of Changes
Other Study ID Numbers: NECTAR-1109
Study First Received: June 28, 2011
Last Updated: December 19, 2013
Health Authority: France: Committee for the Protection of Personnes

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:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014