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
NA
533 participants
INTERVENTIONAL
2018-05-01
2023-05-31
Brief Summary
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Detailed Description
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Subjects in the therapy arm will receive continuous, periodic VNS stimulation after surgery is completed, and will undergo visits for VNS up titration over a period of 3 months. Subjects in the control arm will also undergo scheduled visits at a similar frequency as the titration visits that are scheduled for subjects in the therapy arm. Data for safety and efficacy assessments will be collected for both study arms at 4 weeks post-randomization, every 3 months for the first 12 months, and every 4 months thereafter.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Therapy
VITARIA system implantation on the right cervical vagus nerve in addition to stable guideline-directed medical therapy
VITARIA System
Chronic stimulation of the right cervical vagus nerve
Control
Stable guideline-directed medical therapy
No interventions assigned to this group
Interventions
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VITARIA System
Chronic stimulation of the right cervical vagus nerve
Eligibility Criteria
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Inclusion Criteria
2. Willing and capable of providing informed consent
3. Capable of participating in all testing associated with this clinical investigation
4. Stable, guideline-directed medical therapy for at least 4 weeks before subject screening. Unrestricted changes in diuretics are allowed during the 4 weeks, as long as the subject remains on a diuretic. If the use of an ARNI is being contemplated for a study subject, ARNI should be administered, and GDMT optimized, before the subject is randomized. No more than a 100% increase or 50% decrease of the dosage of any medication other than a diuretic is permitted. For these medications, medication changes within a class are allowed, as long as the equivalent dosage is within these specified limits
5. Stable symptomatic heart failure NYHA class III; or NYHA class II with a heart failure hospitalization in the previous 12 months. HF hospitalization may include an overnight hospital or hospital-based observation unit stay with a primary diagnosis of HF, or an emergency department visit with a primary diagnosis of HF, and will in either case include documentation of intravenous HF therapy administration or other intervention for HF
6. Left ventricular ejection fraction (EF) ≤ 35% and left ventricular end-diastolic diameter (LVEDD) \< 8.0 cm, as confirmed by the core echocardiography laboratory during screening
7. N-terminal pro-BNP (NT-proBNP) level of at least 800 pg/mL, as determined by the core laboratory; or NT-proBNP level of at least 1200 pg/mL, as determined by the core laboratory, for patients with permanent atrial fibrillation or reporting signs or symptoms of atrial fibrillation at the time that the NT-proBNP sample is drawn
8. Received a standard cardiac assessment, including history, physical exam, and electrocardiogram, and determined by a heart failure cardiologist and study surgeon to be an appropriate candidate for the study's surgical procedure
9. Physically capable and willing to perform repeated 6-minute walk tests associated with the study, and having a baseline distance of between 150 and 450 meters. Symptoms limiting the duration of the 6 minute walk test must be due primarily to heart failure
Exclusion Criteria
2. Complete AV block treated with unipolar pacemaker therapy
3. Currently implanted vagus nerve stimulation (VNS) device, baroreceptor activation therapy (BAT) device, other nerve stimulator, artificial or donor heart, or ventricular assist device (VAD)
4. Heart failure of non-ischemic origin for less than 6 months, or due to congenital heart disease, hypertrophic obstructive cardiomyopathy, or infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis)
5. Moderate (3+) or severe (4+) aortic valve or mitral valve stenosis; moderate (3+) or severe (4+) aortic valve insufficiency; or severe (4+) mitral valve insufficiency
6. Symptomatic uncontrolled bradycardia
7. On renal dialysis
8. Involvement in any concurrent clinical study with an investigational therapy
18 Years
ALL
No
Sponsors
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LivaNova
INDUSTRY
Responsible Party
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Locations
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University of Alabama
Birmingham, Alabama, United States
University of Arizona
Tucson, Arizona, United States
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, United States
Long Beach Memorial Hospital
Long Beach, California, United States
Greater Los Angeles VA Medical Center
Los Angeles, California, United States
Hartford Hospital
Hartford, Connecticut, United States
First Coast Cardiovascular Institute
Jacksonville, Florida, United States
UnityPoint Health - Methodist Hospital
Peoria, Illinois, United States
Indiana University Health Ball Memorial Hospital
Muncie, Indiana, United States
Tufts Medical Center
Boston, Massachusetts, United States
Lahey Medical Center
Burlington, Massachusetts, United States
Michigan Heart, PC
Ypsilanti, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Mount Sinai School St. Luke's
New York, New York, United States
MetroHealth System
Cleveland, Ohio, United States
ProMedica Northwest Ohio Cardiology Consultants
Toledo, Ohio, United States
Penn State Health Milton Hershey Medical Center
Hershey, Pennsylvania, United States
Pinnacle Health
Wormleysburg, Pennsylvania, United States
Baylor St. Luke's Medical Center
Houston, Texas, United States
Tyler Cardiovascular Consultants
Tyler, Texas, United States
Providence Sacred Heart Medical Center
Spokane, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
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References
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Premchand RK, Sharma K, Mittal S, Monteiro R, Dixit S, Libbus I, DiCarlo LA, Ardell JL, Rector TS, Amurthur B, KenKnight BH, Anand IS. Autonomic regulation therapy via left or right cervical vagus nerve stimulation in patients with chronic heart failure: results of the ANTHEM-HF trial. J Card Fail. 2014 Nov;20(11):808-16. doi: 10.1016/j.cardfail.2014.08.009. Epub 2014 Sep 1.
Premchand RK, Sharma K, Mittal S, Monteiro R, Dixit S, Libbus I, DiCarlo LA, Ardell JL, Rector TS, Amurthur B, KenKnight BH, Anand IS. Extended Follow-Up of Patients With Heart Failure Receiving Autonomic Regulation Therapy in the ANTHEM-HF Study. J Card Fail. 2016 Aug;22(8):639-42. doi: 10.1016/j.cardfail.2015.11.002. Epub 2015 Nov 11.
Konstam MA, Udelson JE, Butler J, Klein HU, Parker JD, Teerlink JR, Wedge PM, Saville BR, Ardell JL, Libbus I, DiCarlo LA. Impact of Autonomic Regulation Therapy in Patients with Heart Failure: ANTHEM-HFrEF Pivotal Study Design. Circ Heart Fail. 2019 Nov;12(11):e005879. doi: 10.1161/CIRCHEARTFAILURE.119.005879. Epub 2019 Nov 14.
Related Links
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ANTHEM-HFrEF Study Site
Other Identifiers
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C-07
Identifier Type: -
Identifier Source: org_study_id
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