Barostim HOPE4HF (Hope for Heart Failure) Study - Full Text View

Purpose

The purpose of this research study is to show whether the Neo system is safe and works in people with heart failure.

Condition	Intervention
Heart Failure	Device: Barostim Neo system

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Barostim HOPE4HF Study

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

Drug Information available for: Phenylephrine Phenylephrine hydrochloride Oxymetazoline Oxymetazoline hydrochloride

U.S. FDA Resources

Further study details as provided by CVRx, Inc.:

Primary Outcome Measures:

Heart failure metric improvements from baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To describe changes in measures compared to baseline.
System and procedure related adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
To demonstrate the safety of the Neo system in a heart failure population.

Estimated Enrollment:	60
Study Start Date:	November 2012
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	July 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Device Group Barostim Neo system	Device: Barostim Neo system Patients will be implanted with the Neo system. Other Name: Neo system
No Intervention: Medical Management Group Medical management therapy only

Detailed 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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01720160

Contacts

Contact: Tom Moore

763-416-2352

tmoore@cvrx.com

Locations

United States, Arizona
Southwest Cardiovascular Associates	Recruiting
Mesa, Arizona, United States, 85206
Contact: Katherine Ruether 480-945-4343 kruether@swcva.com
Principal Investigator: Charles Jost
Arizona Heart Rhythm Center	Recruiting
Phoenix, Arizona, United States, 53226
Contact: Wendy Schwoegler 480-659-7583 wschwoegler@azheartrhythm.com
Principal Investigator: Vijay Swarup
United States, Florida
ACRC - Cardiology	Recruiting
Atlantis, Florida, United States, 33462
Contact: Rattana Summa 561-966-8815 rsumma@atlanticclinicalresearch.com
Principal Investigator: Norman Erenrich
Florida Hospital Cardiovascular Institute	Recruiting
Orlando, Florida, United States, 32803
Contact: Carol Stastny 407-303-5600 ext 1103439 carol.stastny@flhosp.org
Principal Investigator: Harischandra Karunaratne
Tampa General Hospital	Recruiting
Tampa, Florida, United States, 33606
Contact: Courtney Lee 813-353-8535 courtneyelee@tgh.org
Principal Investigator: Fadi Matar
United States, Georgia
Piedmont Heart Institute	Recruiting
Atlanta, Georgia, United States, 30309
Contact: Tasha Futch-Domohowski 404-605-2371 tasha.futch-domohowski@piedmont.org
Principal Investigator: Nirav Raval
United States, Louisiana
Cardiovascular Institute of the South	Recruiting
Houma, Louisiana, United States, 70360
Contact: Deanna Benoit, LPN, CCRC 985-873-5613 deanna.benoit@cardio.com
Principal Investigator: Richard Abben, MD
United States, Michigan
Cardiac & Vascular Research Center of Northern Michigan	Recruiting
Petosky, Michigan, United States, 49770
Contact: Jennifer LaLonde 231-487-9185 jlalonde@cvrcnm.com
Principal Investigator: Harry Colfer
United States, Ohio
The Ohio State University	Recruiting
Columbus, Ohio, United States, 43210
Contact: Sarah Stockdale 614-292-4084 sarah.stockdale@osumc.edu
Principal Investigator: Rami Kahwash
United States, Oklahoma
Oklahoma Heart Hospital	Recruiting
Oklahoma City, Oklahoma, United States, 73120
Contact: Debby Schommer 405-608-4705 dschommer@ocaheart.com
Principal Investigator: Philip Adamson
United States, Pennsylvania
Allegheny General Hospital	Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Sheila Bernardini 412-359-3281 sbernard@wpahs.org
Principal Investigator: Srinivas Murali
United States, Wisconsin
Aspirus Heart & Vascular Institute	Recruiting
Wausau, Wisconsin, United States, 55401
Contact: Jeff Kaliebe 715-847-2273 ext 52639 jeff.kaliebe@aspirus.org
Principal Investigator: German Larrain
Wheaton Franciscan Healthcare	Recruiting
Wauwatosa, Wisconsin, United States, 53226
Contact: Jane Schimke 414-778-7542 jane.schmike@wfhc.org
Principal Investigator: Charles Lanzarotti

Sponsors and Collaborators

CVRx, Inc.

More Information

No publications provided

Responsible Party:	CVRx, Inc.
ClinicalTrials.gov Identifier:	NCT01720160 History of Changes
Other Study ID Numbers:	360032
Study First Received:	October 29, 2012
Last Updated:	April 26, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013