Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
730 participants
INTERVENTIONAL
2011-02-28
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CardioFit® System
Vagal nerve stimulation with the CardioFit® system
CardioFit® System
Vagal nerve stimulation with the CardioFit® system
Standard of Care
Usual care (no CardioFit System implant)
Standard of Care
Usual care for LV dysfunction and heart failure (no CardioFit System implant)
Interventions
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CardioFit® System
Vagal nerve stimulation with the CardioFit® system
Standard of Care
Usual care for LV dysfunction and heart failure (no CardioFit System implant)
Eligibility Criteria
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Inclusion Criteria
2. Age of at least 18 years.
3. Subjects should be predominately in sinus rhythm at the time of enrollment.
4. On stable optimally uptitrated medical therapy recommended according to current guidelines as standard of care for heart failure therapy.
5. LVEF ≤ 40% per site measurement within three months before enrollment.
6. The left ventricular end diastolic diameter, per site measurement, should be between 50 and 80 mm.
7. The subject is a male or postmenopausal female. Females of childbearing age may be included if an acceptable contraception measure is used.
8. Subject must sign an approved informed consent form. Subject agrees to attend all followup evaluations.
9. Subjects with CRT devices may be included in the trial provided they have had CRT for at least 12 months.
Exclusion Criteria
2. Acute myocardial infarction (MI), variant angina pectoris, unstable angina or acute coronary syndrome in the previous one month.
3. History of stroke or TIA within the previous 3 months or significant neurological damage that would impair the ability to respond to or detect improvement with the vagal nerve stimulation.
4. Coronary Artery Bypass Surgery (CABG), valve replacement or repair, aortic surgery or PCI) in the prior 3 months or planned/anticipated within 6 months.
5. Heart failure due to acute myocarditis, restrictive cardiomyopathy, constrictive pericarditis or hemodynamically significant aortic valve insufficiency, aortic stenosis, or mitral valve stenosis.
6. Severe renal failure (creatinine level \> 3 mg/dL (265 micromole/liter).
7. Severe hepatic failure (transaminase level four times ULN, or total bilirubin level \> 1.8 mmol/dL).
8. Uncontrolled Diabetes Mellitus, which in the opinion of the investigator, would compromise the safety of the implant procedure and/or the ability to respond or detect improvement with vagal nerve stimulation.
9. Previous right neck surgery, including for cerebrovascular disease (CVD), malignancy, and previous irradiation therapy of the neck, which in the opinion of the implanting surgeon, would preclude safe implantation of the vagal nerve cuff. Subjects with more than 70% right carotid artery stenosis assessed on carotid ultrasound are excluded.
10. Current hypotension (systolic blood pressure below 80 mmHg).
11. Active peptic ulcer disease or history of upper GI bleeding, or ulcer within 6 months.
12. History of lung disease such as severe asthma, COPD (e.g., FEV1\<1.5 liter) or continuous oxygen dependence.
13. 2nd or 3rd degree AV block or other pacemaker indication that is not treated with a pacemaker.
14. Chronic atrial fibrillation or flutter in the previous 3 months, or hospitalization for AF due to clinical manifestations of such in the last 6 months.
15. Use of unipolar sensing
16. Congenital or acquired long QT syndrome.
17. Documented recorded or suspected vaso-vagal syncope or vaso depressor syncope.
18. Treatment by investigational drug or device within the past 3 months.
19. The subject must not have received inotropic therapy within 2 months or be considered a possible candidate for inotropic therapy within the next 1 month.
20. Inability to understand the informed consent and/or prior diagnosis of major affective disorder e.g., major depression or bipolar disorder or schizophrenia that requires ongoing treatment and is not adequately controlled by medication.
21. Subjects transplanted with heart or other tissues or organs, or on a heart transplant waiting list and anticipated to receive a transplant within 6 months of randomization.
22. Immunosuppressed subjects; subjects under systemic steroid treatment.
23. Anemia with Hgb ≤ 9.5 g/L. Treatment with erythropoietin or other similar agents is allowed if used to keep Hgb \> 9.5 g/L.
24. Untreated obstructive sleep apnea ("OSA") with apnea-hypopnea index of 15 or more; or OSA that is treated for less than 3-months.
18 Years
ALL
No
Sponsors
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BioControl Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Douglas L. Mann, MD
Role: STUDY_CHAIR
Washington University School of Medicine
Michael Gold
Role: STUDY_CHAIR
Medical University of South Carolina
Locations
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University of Alabama Birmingham
Birmingham, Alabama, United States
Banner Research Institute
Mesa, Arizona, United States
Glendale Memorial Hospital
Glendale, California, United States
Sutter Memorial Hospital
Sacramento, California, United States
Chula Vista Heart Clinic
San Diego, California, United States
South Denver Cardiology
Denver, Colorado, United States
Clearwater Cardiovascular Consultants/Morton Plant
Clearwater, Florida, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Florida Hospital, CV Research Institute
Orlando, Florida, United States
Emory University
Atlanta, Georgia, United States
St. Joseph's Hospital
Atlanta, Georgia, United States
Georgia Arrhythmia Consultants
Macon, Georgia, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Community Heart and Vascular Clinic
Indianapolis, Indiana, United States
Saint Vincent Medical Group
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Detroit Medical Center - Harper Hospital
Detroit, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Detroit Clinical Research Center/Botsford Hospital
Farmington Hills, Michigan, United States
Michigan Cardiovascular Institute
Saginaw, Michigan, United States
Munson Medical Center/Traverse Heart and Vascular
Traverse, Michigan, United States
Park Nicollet / Methodist
Saint Louis Park, Minnesota, United States
United Heart & Vascular
Saint Paul, Minnesota, United States
Cardiology Associates of North Mississippi
Tupelo, Mississippi, United States
St. Luke's Mid America Heart Institute
Kansas City, Missouri, United States
Washington University
St Louis, Missouri, United States
St. Louis Heart and Vascular
St Louis, Missouri, United States
Bryan Heart Institute
Lincoln, Nebraska, United States
Health Care Partners Cardiology/St. Rose Hospital
Las Vegas, Nevada, United States
Mount Sinai
New York, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Montefiore Medical Center/Albert Einstein Colelge of Medicine
The Bronx, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
The Ohio State
Columbus, Ohio, United States
Oklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, United States
Hershey Medical Center/Penn State
Hershey, Pennsylvania, United States
Lancaster Heart and Stroke Foundation
Lancaster, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
VA Tennessee Valley Healthcare System
Nashville, Tennessee, United States
Lone Star Heart Center
Amarillo, Texas, United States
Texas Cardiac Arrhythmia (TCA)
Austin, Texas, United States
Dallas Cardiovascular Associates (CRSTI)
Dallas, Texas, United States
EP Heart/ETHSC at Houston
Houston, Texas, United States
St Lukes Episcopal
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Sentara Norfolk Hospital
Norfolk, Virginia, United States
Kootenai Heart Clinic
Spokane, Washington, United States
Multicare Health System
Tacoma, Washington, United States
Aurora Health Care
Lake Geneva, Wisconsin, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Onze Lieve Vrouwziekenhuis
Aalst, , Belgium
Ziekenhuis Oost Limburg
Genk, , Belgium
Universitair Ziekenhuis Campus Gasthuisberg
Leuven, , Belgium
Uniklinikum Aachen
Aachen, , Germany
Charite Benjamin Franklin Campus
Berlin, , Germany
Charite Campus Virchow-Klinikum Medizinische Klinik mit Schwerpunkt Kardiologie
Berlin, , Germany
St. Josef Hospital
Bochum, , Germany
Asklepios St Georg Hospital
Hamburg, , Germany
Albertinen-Krankenhaus
Hamburg, , Germany
MHH Klinik für Kardiologie und Angiologie
Hanover, , Germany
University of Medicine Mannheim
Mannheim, , Germany
Uniklinikum Muenster
Münster, , Germany
Bnai-Zion Hospital
Haifa, , Israel
University Medical Centre Groningen
Groningen, , Netherlands
Maastricht University Medical Center
Maastricht, , Netherlands
Erasmus University Medical Center Rotterdam
Rotterdam, , Netherlands
Fourth Military Hospital Wroclaw
Wroclaw, , Poland
Medical University of Łodź
Łodź, , Poland
Clinical Centre of Serbia
Belgrade, , Serbia
Clinical Hosptial Centre Bezanijska Kosa
Belgrade, , Serbia
Golden Jubilee National Hospital
Clydebank, Scotland, United Kingdom
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Blackpool Victoria Hospital
Blackpool, , United Kingdom
St. Peter's Hospital
Chertsey, , United Kingdom
University of Hull/Castle Hill Hospital
Cottingham, , United Kingdom
University Hospital Coventry
Coventry, , United Kingdom
Glenfield Hospital
Leicester, , United Kingdom
Royal Brompton Hospital
London, , United Kingdom
Oxford University/John Radcliffe Hospital
Oxford, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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References
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Gold MR, Van Veldhuisen DJ, Hauptman PJ, Borggrefe M, Kubo SH, Lieberman RA, Milasinovic G, Berman BJ, Djordjevic S, Neelagaru S, Schwartz PJ, Starling RC, Mann DL. Vagus Nerve Stimulation for the Treatment of Heart Failure: The INOVATE-HF Trial. J Am Coll Cardiol. 2016 Jul 12;68(2):149-58. doi: 10.1016/j.jacc.2016.03.525. Epub 2016 Apr 4.
Hauptman PJ, Schwartz PJ, Gold MR, Borggrefe M, Van Veldhuisen DJ, Starling RC, Mann DL. Rationale and study design of the increase of vagal tone in heart failure study: INOVATE-HF. Am Heart J. 2012 Jun;163(6):954-962.e1. doi: 10.1016/j.ahj.2012.03.021.
Related Links
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CardioFit Pilot Study Description and Results
Other Identifiers
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CP-05-026
Identifier Type: -
Identifier Source: org_study_id