BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction (HFrEF)
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|ClinicalTrials.gov Identifier: NCT02880618|
Recruitment Status : Recruiting
First Posted : August 26, 2016
Last Update Posted : August 4, 2020
|Condition or disease||Intervention/treatment|
|Heart Failure||Device: Barostim Neo™ System|
The CVRx BAROSTIM THERAPY in Heart Failure with Reduced Ejection Fraction (HFrEF) Registry will be performed with subjects who have been recently implanted with the BAROSTIM NEO System in accordance with CE-Mark approved criteria for heart failure. Subjects must be enrolled within 30 days from implant. Up to 500 subjects will be enrolled at up to 50 sites. Data should be obtained from standard of care measurements taken prior to implant, at enrollment/baseline, and at 3, 6, and 12 months after the device was implanted, at which time each subject will be exited from the registry.
Subjects can be included in the Heart Failure with Reduced Ejection Fraction Registry if they were implanted in the past 30 days and meet the CE-Mark approved indications, and are not contraindicated, for the BAROSTIM NEO System in the treatment of heart failure. The BAROSTIM NEO System is indicated for subjects with heart failure, defined as New York Heart Association (NYHA) functional Class III and left ventricular ejection fraction (LVEF) ≤ 35% despite being treated with the appropriate heart failure guideline directed therapy.
The contraindications are:
- Bilateral carotid bifurcations located above the level of the mandible
- Baroreflex failure or autonomic neuropathy
- Uncontrolled, symptomatic cardiac bradyarrhythmias
- Carotid atherosclerosis that is determined by ultrasound or angiographic evaluation to be greater than 50%
- Ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation
To describe change in the following measures at 3, 6 and 12 months compared to pre-implant baseline:
- New York Heart Association (NYHA) Class
- Six Minute Hall Walk
- Echocardiogram measures
- Biomarkers (e.g. NT-pro BNP, eGFR, Troponin HsT, Cystatin C).
Evaluate health care utilization over follow-up, such as heart failure hospitalizations.
Describe device programming and utilization
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|Target Follow-Up Duration:||12 Months|
|Official Title:||BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction: A Post-Market Registry With the CE-Marked BAROSTIM NEO™ System|
|Actual Study Start Date :||December 13, 2016|
|Estimated Primary Completion Date :||July 2024|
|Estimated Study Completion Date :||July 2024|
- Change in New York Heart Association Functional Classification at 6 months Post-Implant [ Time Frame: Baseline, 6 months post-implant ]To demonstrate that that treatment with BAROSTIM NEO improves New York Heart Association classification.
- Change in Six Minute Hall Walk from Baseline to 6 months Post-Implant [ Time Frame: Baseline, 6 months post-implant ]To demonstrate that that treatment with BAROSTIM NEO improves six-minute hall walk performance.
- Left Ventricular Mass Index Change from Baseline to 6 Months Post-Implant [ Time Frame: Baseline, 6 months post-implant ]To demonstrate that that treatment with BAROSTIM NEO reduces left ventricular mass index.
- Change in Biomarkers from Baseline to 6 months Post-Implant (e.g. NT-pro BNP, eGFR, Troponin HsT, Cystatin C) [ Time Frame: Baseline, 6 months post-implant ]To demonstrate that that treatment with BAROSTIM NEO improves biomarker results.
- Number of Hospitalizations over Follow-Up [ Time Frame: 12 months post-implant ]To demonstrate that that treatment with BAROSTIM NEO reduces hospitalizations.
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): NCT02880618
|Contact: Elizabeth Galleemail@example.com|
|Study Chair:||Jochen Müller-Ehmsen, PhD||Asklepios Klinik Altona|