INcrease Of VAgal TonE in CHF

Stopped early · Phase 3

Conditions studied: Left Ventricular Dysfunction, Heart Failure

In brief

The purpose of the INOVATE-HF study is to demonstrate the long-term safety and efficacy of vagus nerve stimulation with the CardioFit® system for the treatment of subjects with Heart Failure.

Key facts

Study ID

NCT01303718

Run by

BioControl Medical

People needed

730

Starts

2011-02-01

Expected to finish

2015-12-01

Last updated by the study team

2015-12-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Chronic symptomatic heart failure in New York Heart Association functional class III.
• Age of at least 18 years.
• Subjects should be predominately in sinus rhythm at the time of enrollment.
• On stable optimally uptitrated medical therapy recommended according to current guidelines as standard of care for heart failure therapy.
• LVEF ≤ 40% per site measurement within three months before enrollment.
• The left ventricular end diastolic diameter, per site measurement, should be between 50 and 80 mm.
• The subject is a male or postmenopausal female. Females of childbearing age may be included if an acceptable contraception measure is used.
• Subject must sign an approved informed consent form. Subject agrees to attend all followup evaluations.
• Subjects with CRT devices may be included in the trial provided they have had CRT for at least 12 months.

You may not qualify if…

• Presence of a life threatening condition or disease other than heart failure, that is likely to lead to death within 6 months.
• Acute myocardial infarction (MI), variant angina pectoris, unstable angina or acute coronary syndrome in the previous one month.
• 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.
• Coronary Artery Bypass Surgery (CABG), valve replacement or repair, aortic surgery or PCI) in the prior 3 months or planned/anticipated within 6 months.
• Heart failure due to acute myocarditis, restrictive cardiomyopathy, constrictive pericarditis or hemodynamically significant aortic valve insufficiency, aortic stenosis, or mitral valve stenosis.
• Severe renal failure (creatinine level > 3 mg/dL (265 micromole/liter).
• Severe hepatic failure (transaminase level four times ULN, or total bilirubin level > 1.8 mmol/dL).
• 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.
• 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.
• Current hypotension (systolic blood pressure below 80 mmHg).
• Active peptic ulcer disease or history of upper GI bleeding, or ulcer within 6 months.
• History of lung disease such as severe asthma, COPD (e.g., FEV1<1.5 liter) or continuous oxygen dependence.
• 2nd or 3rd degree AV block or other pacemaker indication that is not treated with a pacemaker.
• 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.
• Use of unipolar sensing
• Congenital or acquired long QT syndrome.
• Documented recorded or suspected vaso-vagal syncope or vaso depressor syncope.
• Treatment by investigational drug or device within the past 3 months.
• 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.
• 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.
• 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.
• Immunosuppressed subjects; subjects under systemic steroid treatment.
• 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.
• Untreated obstructive sleep apnea ("OSA") with apnea-hypopnea index of 15 or more; or OSA that is treated for less than 3-months.

Where it is running

• 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
• University of Alabama Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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