Overview

This trial is active, not recruiting.

Condition heart failure
Treatments barostim neo system, standard of care medical managment
Sponsor CVRx, Inc.
Start date November 2012
End date May 2015
Trial size 98 participants
Trial identifier NCT01720160, 360032

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Barostim Neo system
barostim neo system Neo system
Patients will be implanted with the Neo system.
(Active Comparator)
Medical management therapy only
standard of care medical managment Patients will continue with medical therapy for standard of care of their heart failure condition

Primary Outcomes

Measure
Heart failure metric improvements from baseline
time frame: 12 months
System and procedure related adverse events
time frame: 6 months

Eligibility Criteria

Male or female participants at least 21 years old.

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by CVRx, Inc..