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Terminated Phase 3 Interventional

INcrease Of VAgal TonE in CHF

ClinicalTrials.gov ID: NCT01303718

Public ClinicalTrials.gov record NCT01303718. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 6:52 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

INcrease Of VAgal TonE in CHF (INOVATE-HF) - A Randomized Study to Establish the Safety and Efficacy of CardioFit® for the Treatment of Subjects With Heart Failure and Left Ventricular Dysfunction

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01303718
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Lead sponsor
BioControl Medical
Industry
Enrollment
730 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 2011 (Type not available)
Primary completion
Dec 2015 (Actual)
Completion
Dec 2015 (Actual)
Last update posted
Dec 15, 2015

2011 – 2015

United States locations

U.S. sites
57
U.S. states
27
U.S. cities
50
Facility City State ZIP Site status
University of Alabama Birmingham Birmingham Alabama 35294 —
Banner Research Institute Mesa Arizona 85206 —
Glendale Memorial Hospital Glendale California 91204 —
Sutter Memorial Hospital Sacramento California 95819 —
Chula Vista Heart Clinic San Diego California 91910 —
South Denver Cardiology Denver Colorado 80120 —
Clearwater Cardiovascular Consultants/Morton Plant Clearwater Florida 33756 —
Mayo Clinic Jacksonville Jacksonville Florida 32224 —
Florida Hospital, CV Research Institute Orlando Florida 32803 —
Emory University Atlanta Georgia 30322 —
St. Joseph's Hospital Atlanta Georgia 30342 —
Georgia Arrhythmia Consultants Macon Georgia 31201 —
Advocate Christ Medical Center Oak Lawn Illinois 60453 —
Community Heart and Vascular Clinic Indianapolis Indiana 46250 —
Saint Vincent Medical Group Indianapolis Indiana 46260 —
University of Iowa Iowa City Iowa 52242 —
Massachusetts General Hospital Boston Massachusetts 02114 —
Beth Israel Deaconess Boston Massachusetts 02215 —
University of Michigan Ann Arbor Michigan 48109 —
Detroit Medical Center - Harper Hospital Detroit Michigan 48201 —
Henry Ford Health System Detroit Michigan 48202 —
Detroit Clinical Research Center/Botsford Hospital Farmington Hills Michigan 48334 —
Michigan Cardiovascular Institute Saginaw Michigan 48601 —
Munson Medical Center/Traverse Heart and Vascular Traverse Michigan 49684 —
Park Nicollet / Methodist Saint Louis Park Minnesota 55426 —
United Heart & Vascular Saint Paul Minnesota 55102 —
Cardiology Associates of North Mississippi Tupelo Mississippi 38801 —
St. Luke's Mid America Heart Institute Kansas City Missouri 64111 —
Washington University St Louis Missouri 63110 —
St. Louis Heart and Vascular St Louis Missouri 63136 —
Bryan Heart Institute Lincoln Nebraska 68506 —
Health Care Partners Cardiology/St. Rose Hospital Las Vegas Nevada 89169-2579 —
Mount Sinai New York New York 10029 —
Stony Brook University Medical Center Stony Brook New York 11794 —
Montefiore Medical Center/Albert Einstein Colelge of Medicine The Bronx New York 10467 —
University of Cincinnati Cincinnati Ohio 45267-0542 —
MetroHealth Medical Center Cleveland Ohio 44109 —
Cleveland Clinic Foundation Cleveland Ohio 44195 —
The Ohio State Columbus Ohio 43210 —
Oklahoma Cardiovascular Research Group Oklahoma City Oklahoma 73120 —
Hershey Medical Center/Penn State Hershey Pennsylvania 17033 —
Lancaster Heart and Stroke Foundation Lancaster Pennsylvania 17602 —
Thomas Jefferson University Philadelphia Pennsylvania 19107 —
Allegheny General Hospital Pittsburgh Pennsylvania 15212 —
Medical University of South Carolina Charleston South Carolina 29425 —
VA Tennessee Valley Healthcare System Nashville Tennessee 37212 —
Lone Star Heart Center Amarillo Texas 79106 —
Texas Cardiac Arrhythmia (TCA) Austin Texas 78705 —
Dallas Cardiovascular Associates (CRSTI) Dallas Texas 75230 —
EP Heart/ETHSC at Houston Houston Texas 77030 —
St Lukes Episcopal Houston Texas 77030 —
University of Utah Salt Lake City Utah 84132 —
Sentara Norfolk Hospital Norfolk Virginia 23507 —
Kootenai Heart Clinic Spokane Washington 99204 —
Multicare Health System Tacoma Washington 98405 —
Aurora Health Care Lake Geneva Wisconsin 53147 —
Marshfield Clinic Marshfield Wisconsin 54449 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 30 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01303718, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 15, 2015 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01303718 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →