Status:
TERMINATED
ANTHEM-HFrEF Pivotal Study
Lead Sponsor:
LivaNova
Conditions:
Heart Failure
Heart Failure, Congestive
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A multi-center randomized controlled clinical trial to evaluate Autonomic Regulation Therapy with the VITARIA system in patients with symptomatic heart failure and reduced ejection fraction.
Detailed Description
ANTHEM-HFrEF is a multi-center, open-label, randomized controlled clinical trial with an adaptive design. Patients with symptomatic heart failure and reduced LVEF will be enrolled and randomized 2:1 t...
Eligibility Criteria
Inclusion
- Age 18 or above
- Willing and capable of providing informed consent
- Capable of participating in all testing associated with this clinical investigation
- 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
- 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
- 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
- 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
- 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
- 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
- Refractory symptomatic hypotension (systolic blood pressure below 80 mmHg)
- Complete AV block treated with unipolar pacemaker therapy
- Currently implanted vagus nerve stimulation (VNS) device, baroreceptor activation therapy (BAT) device, other nerve stimulator, artificial or donor heart, or ventricular assist device (VAD)
- 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)
- 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
- Symptomatic uncontrolled bradycardia
- On renal dialysis
- Involvement in any concurrent clinical study with an investigational therapy
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2023
Estimated Enrollment :
533 Patients enrolled
Trial Details
Trial ID
NCT03425422
Start Date
May 1 2018
End Date
May 31 2023
Last Update
October 10 2023
Active Locations (22)
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1
University of Alabama
Birmingham, Alabama, United States, 35294
2
University of Arizona
Tucson, Arizona, United States, 85724
3
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, United States, 72205
4
Long Beach Memorial Hospital
Long Beach, California, United States, 90806