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ANTHEM-HFrEF Pivotal Study

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ClinicalTrials.gov Identifier: NCT03425422
Recruitment Status : Not yet recruiting
First Posted : February 7, 2018
Last Update Posted : February 7, 2018
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Heart Failure Heart Failure, Congestive Heart Failure, Systolic Device: VITARIA System

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 to receive VITARIA system implantation on the right cervical vagus nerve in addition to stable guideline-directed medical therapy (therapy), or to continue receiving stable guideline-directed medical therapy alone (control arm).

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autonomic Regulation Therapy to Enhance Myocardial Function and Reduce Progression of Heart Failure With Reduced Ejection Fraction
Anticipated Study Start Date : April 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Therapy
VITARIA system implantation on the right cervical vagus nerve in addition to stable guideline-directed medical therapy
Device: VITARIA System
Chronic stimulation of the right cervical vagus nerve
No Intervention: Control
Stable guideline-directed medical therapy

Primary Outcome Measures :
  1. Event-free rate [ Time Frame: 90 days ]
    The event-free rate, through 90 days after VITARIA implantation, from all VITARIA system-related and VITARIA implantation-related serious adverse events, as adjudicated by the Clinical Events Committee

  2. Cardiovascular mortality and HF hospitalization [ Time Frame: Through study completion, an average of 2 years ]
    A composite of cardiovascular mortality or heart failure hospitalization, as adjudicated by the Clinical Events Committee, based on time to first event after randomization

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age 18 or above
  2. Willing and capable of providing informed consent
  3. Capable of participating in all testing associated with this clinical investigation
  4. Currently in sinus rhythm
  5. Stable, guideline-directed medical therapy for at least 4 weeks.
  6. Stable symptomatic heart failure NYHA class III; or NYHA class II with a heart failure hospitalization in the previous 6 months
  7. Left ventricular ejection fraction (EF) ≤ 35%, as confirmed by core echocardiography laboratory during screening
  8. N-terminal pro-BNP (NT-proBNP) level of at least 800 pg/mL within 45 days of randomization; or NT-proBNP level of at least 400 pg/mL with a heart failure hospitalization in the previous 12 months
  9. 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
  10. 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:

  1. Refractory symptomatic hypotension (systolic blood pressure below 80 mmHg)
  2. Pacemaker dependence (permanent pacemaker implantation for third-degree AV block)
  3. Currently implanted vagus nerve stimulation (VNS) device, cardiac resynchronization therapy (CRT) device, baroreceptor stimulation (BRS) device, 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. Severe mitral or aortic valve disorder
  6. Symptomatic uncontrolled bradycardia
  7. Chronic (permanent) atrial fibrillation
  8. Involvement in any concurrent clinical study with an investigational therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03425422

Contact: Patricia Wedge 617-423-7999 pwedge@ccstrials.com

Sponsors and Collaborators

Additional Information:
Responsible Party: LivaNova
ClinicalTrials.gov Identifier: NCT03425422     History of Changes
Other Study ID Numbers: C-07
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by LivaNova:
Vagus nerve stimulation

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases