Trial record 8 of 868 for:    Open Studies | "Heart Failure"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Boston Scientific Corporation
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01385176
First received: June 28, 2011
Last updated: July 31, 2015
Last verified: July 2015
  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 2018
Estimated Primary Completion Date: May 2017 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01385176

Contacts
Contact: Bernd D Schubert, Dr. +49 (0)30 94 34 023 bernd.schubert@bsci.com
Contact: Stephen B Ruble, Ph.D. +1 651.582.4397 stephen.ruble@bsci.com

Locations
Belgium
UCL Bruxelles Recruiting
Brussels, Belgium, 1200
Contact: Jean-Benoit le Polain de Waroux, MD, PhD    +32 2 764 11 11 ext 2894    jean-benoit.lepolain@uclouvain.be   
Czech Republic
Nemocnice Na Homolce Recruiting
Prague, Czech Republic, 15030
Contact: Petr Neuzil, MD    +420 257272391    petr.neuzil@homolka.cz   
France
Centre d'Investigation Clinique Pierre Drouin, CHU de Nancy Recruiting
Vandoeuvre les Nancy, Nancy, France, 54500
Contact: Faiez Zannad, MD    +33 3 83 15 73 22    f.zannad@chu-nancy.fr   
CHRU de Lille - Hôpital Cardiologique Recruiting
Lille, France, 59037
Contact: Salem Kacet, MD, PhD    +33 3 20 44 50 15    salem.kacet@chru-lille.fr   
Pitié Salpétrière Recruiting
Paris, France, 75013
Contact: Françoise Hidden-Lucet, MD    +33 (0) 1 42 16 30 51    francoise.hidden-lucet@psl.aphp.fr   
Germany
Immanuel Klinikum Bernau Herzzentrum Brandenburg Recruiting
Bernau, Brandenburg, Germany, 16321
Contact: Christian Butter, MD    +49 3338 694 610    c.butter@immanuel.de   
Universitätsmedizin Göttingen Recruiting
Göttingen, Germany, 37075
Contact: Markus Zabel, Prof. MD    +49 (551) 3910265    markus.zabel@med.uni-goettingen.de   
Universitäres Herzzentrum GmbH, Universitätsklinikum Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Muhammet Ali Aydin, MD    +49 (40) 741059471    aydin@uke.de   
Universitätsklinikum Leipzig Recruiting
Leipzig, Germany, 04103
Contact: Christian Kühne, MD    +49 341 9712650    christian.kuehne@medizin.uni-leipzig.de   
Universitätsklinikum Rostock Recruiting
Rostock, Germany, 18057
Contact: Dietmar Bänsch, Prof. MD    +49 381 4947797    Dietmar.Baensch@med.uni-rostock.de   
Italy
Azienda Ospedaliera Niguarda Cà Granda Recruiting
Milano, Italy, 20162
Contact: Maurizio Lunati, MD    +39 0264442611    Maurizio.lunati@ospedaleniguarda.it   
A. O. Dei Colli - Monaldi Recruiting
Napoli, Italy, 80131
Contact: Antonio D'Onofrio, MD    0817062605    donofrioant@iol.it   
Policlinico San Matteo Recruiting
Pavia, Italy, 27100
Contact: Gaetano De Ferrari, MD    +39 0382503715    g.deferrari@smatteo.pv.it   
Netherlands
Catharina Ziekenhuis Eindhoven Recruiting
Eindhoven, Netherlands, 5623EJ
Contact: Cees-Joost Botman, MD    +31 40 239 8360    cees-joost.botman@catharinaziekenhuis.nl   
UMC Utrecht Recruiting
Utrecht, Netherlands, 3584CX
Contact: Anton Tuinenburg    +31 88 75 594 52 ext # 11 3924    A.E.Tuinenburg@umcutrecht.nl   
Spain
Hospital Doce de Octubre Recruiting
Madird, Madrid, Spain, 28041
Contact: María López Gil, MD    +0034913908070    mlopezgil@secardiologia.es   
Hospital Puerta de Hierro Recruiting
Majadahonda, Madrid, Spain, 28222
Contact: Ignacio Fernández Lozano, MD    91 191 66 44    iflozano@secardiologia.es   
Clínica Universitaria de Navarra, Avenida Pio XII s/n Recruiting
Pamplona, Navarra, Spain, 31008
Contact: Juan José Gavira Gómez, MD    +0034948174539    jjgavira@unav.es   
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Maria Castel, MD    +34932275493    macastel@clinic.ub.es   
United Kingdom
University Hospitals Bristol, NHS Foundation Trust Recruiting
Bristol, England, United Kingdom, BS2 8HW
Contact: Angus Nightingale, MD    0044 117 342 6572    Angus.Nightingale@UHBristol.nhs.uk   
Liverpool Heart and Chest Hospital, NHS Foundation Trust Recruiting
Liverpool, England, United Kingdom, L14 3PD
Contact: David Wright, MD    0044 151 600 1457    David.Wright@lhch.nhs.uk   
Imperial College Healthcare NHS Trust, St. Mary's Hospital Recruiting
London, England, United Kingdom, W2 1NY
Contact: Prapa Kanagaratnam, MD    0044 2078861657    p.kanagaratnam@imperial.ac.uk   
The Heart Hospital, University College London Hospitals, NHS Foundation Trust Recruiting
London, England, United Kingdom, W1G 8PH
Contact: Pier Lambiase, MD    0044 203 456 4011    Pier.Lambiase@uclh.nhs.uk   
King's College Hospital NHS Foundation Trust Recruiting
London, United Kingdom, SE5 9RS
Contact: Francis Murgatroyd, MD    +44 203 2991285    Francis.Murgatroyd@nhs.net   
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

Publications:
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: July 31, 2015
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
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on August 27, 2015