Barostim Neo® - Baroreflex Activation Therapy® for Heart Failure (BeAT-HF)
|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: NCT02627196|
Recruitment Status : Active, not recruiting
First Posted : December 10, 2015
Last Update Posted : November 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Device: BAROSTIM NEO® System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||938 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Open Label|
|Official Title:||Barostim Neo® - Baroreflex Activation Therapy® for Heart Failure|
|Actual Study Start Date :||April 2016|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2021|
Experimental: Device Arm
Subjects will receive Barostim Activation Therapy® with the implanted BAROSTIM NEO® System in addition to optimal guideline directed medical management.
Device: BAROSTIM NEO® System
No Intervention: Guideline Directed Medical Management
Patients will be followed under optimal guideline directed medical management.
- Rate of Cardiovascular Mortality and Heart Failure Morbidity [ Time Frame: At study completion, approximately 5 years ]To demonstrate that treatment with the BAROSTIM NEO® System, relative to medical management, reduces the rate of cardiovascular mortality or worsening heart failure that leads to hospitalization, cardiac assist device or heart transplant.
- Major Adverse Neurological and Cardiovascular Events (MANCE) [ Time Frame: 6 months post implant ]To demonstrate the safety of the Barostim NEO® System via the event-free rate of all system- and procedure-related Major Adverse Neurological and Cardiovascular Events (MANCE) occurring within 6 months post implant in the device arm.
- Amino-terminal prohormone of brain natriuretic peptide (NT-proBNP) [ Time Frame: 6 months post implant ]To demonstrate that treatment with the BAROSTIM NEO® system results in a larger reduction in NT-proBNP at 6 months than medical management.
- Six Minute Hall Walk (6MHW) [ Time Frame: 6 months post implant. ]To demonstrate that treatment with the BAROSTIM NEO® system results in a larger improvement in 6MHW at 6 months than medical management
- Minnesota Living With Heart Failure Quality of Life (MLWHF QOL) [ Time Frame: 6 months post implant ]To demonstrate that treatment with the BAROSTIM NEO® System results in a larger improvement in MLWHF QOL at 6 months than medical management
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): NCT02627196
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