BAROSTIM THERAPY™ In Heart Failure With Preserved Ejection Fraction

Heart Failure Clinical Trial

— HFpEF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02876042
• Other study ID #: 360047-001
• Status: Recruiting
• Start date: March 23, 2017
• Est. completion date: July 2024

Study information

• Verified date: April 2023
• Source: CVRx, Inc.
• Contact: Elizabeth Galle
• Phone: 763-416-2876
• Email: lgalle[@]cvrx.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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).

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• BAROSTIM NEO™ System
Implantation of the BAROSTIM NEO™ System

Locations

Country	Name	City	State
Germany	Berlin Charité & Deutschen Herzzentrum Berlin	Berlin
Germany	Immanuel Klinikum Bernau Herzzentrum Brandenburg	Bernau
Germany	Lippe Klinikum	Detmold
Germany	Uniklinik Frankfurt	Frankfurt
Germany	Universitätsklinikum Gießen und Marburg	Gießen
Germany	Herzzentrum Göttingen	Göttingen
Germany	Asklepios Klinik Altona	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Uniklinik Heidelberg	Heidelberg
Germany	Kardiologie im Klinikum Ingolstadt	Ingolstadt
Germany	Universitätsklinikum Köln Herzzentrum	Köln
Germany	Universitätsklinikum Regensburg	Regensburg
Germany	Marienkrankenhaus Siegen	Siegen

Sponsors (1)

Lead Sponsor	Collaborator
CVRx, Inc.

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Georgakopoulos D, Little WC, Abraham WT, Weaver FA, Zile MR. Chronic baroreflex activation: a potential therapeutic approach to heart failure with preserved ejection fraction. J Card Fail. 2011 Feb;17(2):167-78. doi: 10.1016/j.cardfail.2010.09.004. Epub 2010 Oct 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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