BAROSTIM THERAPY™ In Heart Failure With Preserved Ejection Fraction

Study Overview
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Brief Summary
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The purpose of this registry (NCT02876042) is to evaluate the effect of BAROSTIM THERAPY with the BAROSTIM NEO system in the commercial setting in subjects recently implanted under the CE-Marked indication for resistant hypertension that also have evidence of heart failure with preserved ejection fraction (HFpEF).

Detailed Description
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Summary: The CVRx BAROSTIM THERAPY in Heart Failure with Preserved Ejection Fraction (HFpEF) Registry will be performed with subjects who have been recently implanted with the BAROSTIM NEO System in accordance with CE-Mark approved criteria for resistant hypertension and have evidence of HFpEF per the registry enrollment criteria. Subjects must be enrolled within 30 days from implant but prior to therapy activation. Up to 70 subjects will be enrolled at up to 10 sites. Data should be obtained from standard of care measurements taken prior to implant, at enrollment/baseline, and at 3 and 6 months after the device was implanted, at which time each subject will be exited from the registry. Eligibility Criteria: The CE-Mark approved indications and contraindications for the BAROSTIM NEO system in the treatment of resistant hypertension include: Indications Systolic blood pressure greater than or equal to 140 mmHg, and Resistance to maximally tolerated therapy with a diuretic and two other anti-hypertension medications Contraindications 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

Official Title
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BAROSTIM THERAPY ™ in Heart Failure With Preserved Ejection Fraction: A Post-Market Registry With the CE-Marked BAROSTIM NEO™ System

Conditions
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Heart Failure

Intervention / Treatment
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* Device: BAROSTIM NEO™ System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign an Ethics Committee (EC) approved informed consent form for the registry. Implanted with the BAROSTIM NEO system in accordance with CE-Mark approved indications and contraindications for resistant hypertension within 30 days prior to enrollment. BAROSTIM THERAPY not yet chronically activated. Pre-implant echocardiogram with left ventricular ejection fraction ≥ 50% within 30 days prior to implant. On stable, maximally-tolerated, guideline-directed cardiovascular medications for at least 30 days prior to enrollment. Objective evidence of heart failure according to the following criteria: Hospitalization for heart failure within 12 months prior to enrollment OR Echocardiographic evidence of diastolic dysfunction (LA Volume Index >34 ml/m2 OR E/e >13) within 30 days prior to enrollment OR NTproBNP > 220 pg/mL or BNP > 80 pg/mL (in atrial fibrillation, NTproBNP > 600 pg/mL or BNP > 200 pg/mL) within 30 days prior to enrollment Exclusion Criteria: Heart failure secondary to a reversible or treatable condition such as, cardiac structural valvular disease, acute myocarditis and pericardial constriction. Heart failure secondary to right ventricular failure or right ventricular myocardial infarction.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: BAROSTIM NEO™ System|Implantation of the BAROSTIM NEO™ System|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Office Cuff Systolic Blood Pressure | Office cuff blood pressure measurement to be obtained from a time point prior to implant and as close to the implant procedure as possible (baseline), and at 3 and 6 months post-implant. | Pre-implant baseline to 6 months post-implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in New York Heart Association Functional Classification | New York Heart Association Classification, if available, should be obtained from a time point prior to implant and as close to the implant procedure as possible (baseline), and at 3 and 6 months post-implant. | Pre-implant baseline to 6 months post-implant | 
| Changes in Left Ventricular Mass Index | An echocardiogram obtained prior to implant, and as close to the implant procedure as possible, will be utilized for the baseline measurement. An additional echocardiogram will be obtained at 3 and 6 months post-implant. | Pre-implant baseline to 6 months post-implant | 
| Changes in LA volume index | An echocardiogram obtained prior to implant, and as close to the implant procedure as possible, will be utilized for the baseline measurement. An additional echocardiogram will be obtained at 3 and 6 months post-implant. | Pre-implant baseline to 6 months post-implant | 
| Changes in E/E' ratio | An echocardiogram obtained prior to implant, and as close to the implant procedure as possible, will be utilized for the baseline measurement. An additional echocardiogram will be obtained at 3 and 6 months post-implant. | Pre-implant baseline to 6 months post-implant | 
| Changes in NT-proBNP | If available, measurement should be obtained from a time point prior to implant and as close to the implant procedure as possible (baseline), and at 3 and 6 months post-implant. | Pre-implant baseline, 6 months post-implant | 
| Evaluate health care utilization over follow-up, such as heart failure hospitalizations | Health care utilization information is collected throughout follow-up. | Pre-implant baseline to 6 months post-implant |