Barostim HOPE4HF (Hope for Heart Failure) Study
This trial is active, not recruiting.
|Treatments||barostim neo system, standard of care medical managment|
|Start date||November 2012|
|End date||May 2015|
|Trial size||98 participants|
|Trial identifier||NCT01720160, 360032|
The purpose of this research study is to show whether the Neo system is safe and works in people with heart failure. The study is currently in long-term follow up.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Mesa, AZ||Southwest Cardiovascular Associates||no longer recruiting|
|Phoenix, AZ||Arizona Heart Rhythm Center||no longer recruiting|
|Los Angeles, CA||University of Southern California||no longer recruiting|
|Washington D.C., DC||George Washington University||no longer recruiting|
|Atlantis, FL||ACRC - Cardiology||no longer recruiting|
|Orlando, FL||Florida Hospital Cardiovascular Institute||no longer recruiting|
|Tampa, FL||Tampa General Hospital||no longer recruiting|
|Atlanta, GA||Piedmont Heart Institute||no longer recruiting|
|Naperville, IL||Advocate Medical Group||no longer recruiting|
|Houma, LA||Cardiovascular Institute of the South||no longer recruiting|
|Brighton, MA||St Elizabeth's Medical Center||no longer recruiting|
|Midland, MI||Mid-Michigan Medical Center Midland||no longer recruiting|
|Petosky, MI||Cardiac & Vascular Research Center of Northern Michigan||no longer recruiting|
|Jackson, MS||University of Mississippi Medical Center||no longer recruiting|
|Las Vegas, NV||University Medical Center of Southern Nevada||no longer recruiting|
|Hackensack, NJ||Hackensack University Medical Center||no longer recruiting|
|Columbus, OH||The Ohio State University||no longer recruiting|
|Oklahoma City, OK||Oklahoma Cardiovascular Research Group||no longer recruiting|
|Philadelphia, PA||Drexel University College of Medicine||no longer recruiting|
|Pittsburgh, PA||Allegheny General Hospital||no longer recruiting|
|Amarillo, TX||Lonestar Heart Center||no longer recruiting|
|Milwaukee, WI||Wheaton Franciscan Healthcare||no longer recruiting|
|Wausau, WI||Aspirus Heart & Vascular Institute||no longer recruiting|
|Intervention model||parallel assignment|
Heart failure metric improvements from baseline
time frame: 12 months
System and procedure related adverse events
time frame: 6 months
All participants at least 21 years old.
- Age 21 years or above.
- On optimal, guideline-directed (per the American Heart Association/American College of Cardiology guidelines), stable, heart-failure medications and dose for at least 4 weeks prior to screening.
- Known or suspected baroreflex failure or autonomic neuropathy.
- Myocardial infarction, unstable angina, syncope, cerebral vascular accident, sudden cardiac death (SCD), or received defibrillation therapy within 3 months.
- Heart failure secondary to a reversible cause or treatable condition.
|Official title||Barostim HOPE4HF Study|
|Description||A prospective, randomized study describing the safety and efficacy of the Neo system in approximately 60 heart failure subjects with a left ventricular ejection fraction equal or less than 35 percent.|
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