Barostim Therapy for Heart Failure (BeAT-HF)
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|ClinicalTrials.gov Identifier: NCT02627196|
Recruitment Status : Recruiting
First Posted : December 10, 2015
Last Update Posted : October 11, 2017
|Condition or disease||Intervention/treatment|
|Heart Failure||Device: BAROSTIM NEO® System|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02627196
|Contact: Liz Gallefirstname.lastname@example.org|
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