Barostim HOPE4HF (Hope for Heart Failure) Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01720160|
Recruitment Status : Active, not recruiting
First Posted : November 2, 2012
Last Update Posted : January 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Device: Barostim Neo system Other: Standard of care medical managment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||98 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Barostim HOPE4HF Study|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||May 2015|
|Estimated Study Completion Date :||January 2021|
Experimental: Device Group
Barostim Neo system
Device: Barostim Neo system
Patients will be implanted with the Neo system.
Other Name: Neo system
Active Comparator: Medical Management Group
Medical management therapy only
Other: Standard of care medical managment
Other Name: Patients will continue with medical therapy for standard of care of their heart failure condition
- Heart failure metric improvements from baseline [ Time Frame: 12 months ]To describe changes in measures compared to baseline.
- System and procedure related adverse events [ Time Frame: 6 months ]To demonstrate the safety of the Neo system in a heart failure population.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01720160
Show 23 Study Locations