Clincosm LogoSign in Get a demo

ANTHEM-HFrEF Pivotal Study

Sponsor
LivaNova (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03425422
Collaborator
(none)
800
Enrollment
22
Locations
2
Arms
79
Anticipated Duration (Months)
36.4
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Device: VITARIA System
 N/A

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 Design

Study Type:
Interventional
Anticipated 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
Actual Study Start Date :
May 1, 2018
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Event-free rate [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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. 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:

  1. Refractory symptomatic hypotension (systolic blood pressure below 80 mmHg)

  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

Contacts and Locations

Locations

Site City State Country Postal Code
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
5 Greater Los Angeles VA Medical Center Los Angeles California United States 90073
6 Hartford Hospital Hartford Connecticut United States 06102
7 First Coast Cardiovascular Institute Jacksonville Florida United States 32256
8 UnityPoint Health - Methodist Hospital Peoria Illinois United States 61606
9 Indiana University Health Ball Memorial Hospital Muncie Indiana United States 47303
10 Tufts Medical Center Boston Massachusetts United States 02111
11 Lahey Medical Center Burlington Massachusetts United States 01805
12 Michigan Heart, PC Ypsilanti Michigan United States 48197
13 University of Mississippi Medical Center Jackson Mississippi United States 39216
14 Mount Sinai School St. Luke's New York New York United States 10025
15 MetroHealth System Cleveland Ohio United States 44109
16 ProMedica Northwest Ohio Cardiology Consultants Toledo Ohio United States 43606
17 Penn State Health Milton Hershey Medical Center Hershey Pennsylvania United States 17033
18 Pinnacle Health Wormleysburg Pennsylvania United States 17043
19 Baylor St. Luke's Medical Center Houston Texas United States 77030
20 Tyler Cardiovascular Consultants Tyler Texas United States 75701
21 Providence Sacred Heart Medical Center Spokane Washington United States 99204
22 University of Wisconsin Madison Wisconsin United States 53792

Sponsors and Collaborators

  • LivaNova

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
LivaNova
ClinicalTrials.gov Identifier:
NCT03425422
Other Study ID Numbers:
  • C-07
First Posted:
Feb 7, 2018
Last Update Posted:
Jun 2, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by LivaNova
Vagus nerve stimulation
Additional relevant MeSH terms:
Heart Failure
Heart Failure, Systolic

Study Results

No Results Posted as of Jun 2, 2022