BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction

Heart Failure Clinical Trial

— HFrEF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02880618
• Other study ID #: 360049-001
• Status: Recruiting
• Start date: December 13, 2016
• 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 (NCT02880618) 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 heart failure with reduced ejection fraction (HFrEF).

Description:

Summary:

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.

Eligibility:

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

Objectives:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• 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:

• Subject has 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

• Subject has been implanted with the BAROSTIM NEO System in the past 30 days

• Subject has signed an Ethics Committee approved informed consent form

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Barostim Neo™ System

Locations

Country	Name	City	State
Germany	Herzzentrum Bad Oyenhausen	Bad Oeynhausen
Germany	Berlin Charité & Deutschen Herzzentrum Berlin	Berlin
Germany	Charité Campus Virchow Klinikum	Berlin
Germany	Immanuel Klinikum Bernau Herzzentrum Brandenburg	Bernau
Germany	Medizinisches Versorgungszentrum am Küchwald GmbH	Chemnitz
Germany	Lippe Klinikum	Detmold
Germany	Dresden Friedrichstadt	Dresden
Germany	Herzzentrum Dresden - Interventionelle Kardiologie	Dresden
Germany	Herzzentrum Dresden, Elektrophysiologie	Dresden
Germany	Uniklinik Frankfurt	Frankfurt
Germany	Universitätsklinikum Gießen und Marburg	Gießen
Germany	Herzzentrum Göttingen	Göttingen
Germany	Albertinen-Krankenhaus	Hamburg
Germany	Asklepios Klinik Altona	Hamburg
Germany	St. Barbara Klinik Hamm	Hamm
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Kardiologie im Klinikum Ingolstadt	Ingolstadt
Germany	Universitätsklinikum Schleswig-Holstein Campus Kiel	Kiel
Germany	Universitätsklinikum Köln Herzzentrum	Köln
Germany	Herzentrum Lahr	Lahr
Germany	Leipzig St. Georg	Leipzig
Germany	Universitätsklinikum Leipzig	Leipzig
Germany	Universitätsklinik Mainz	Mainz
Germany	Clemenshospital Münster	Münster
Germany	St. Vincenz-Krankenhaus	Paderborn
Germany	Universitätsklinikum Regensburg	Regensburg
Germany	Marienkrankenhaus Siegen	Siegen
Germany	Krankenhaus & MVZ Maria-Hilf Stadtlohn GmbH	Stadtlohn
Germany	Klinikum Tuttlingen	Tuttlingen
Italy	Fondazione di Ricerca e Cura "Giovanni Paolo II"	Campobasso

Sponsors (1)

Lead Sponsor	Collaborator
CVRx, Inc.

Countries where clinical trial is conducted

Germany,  Italy, 

References & Publications (5)

Abraham WT, Zile MR, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Muller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Little WC. Baroreflex Activation Therapy for the Treatment of Heart Failure With a Reduced Ejection Fraction. JACC Heart Fail. 2015 Jun;3(6):487-496. doi: 10.1016/j.jchf.2015.02.006. Epub 2015 May 14. — View Citation

Gronda E, Seravalle G, Brambilla G, Costantino G, Casini A, Alsheraei A, Lovett EG, Mancia G, Grassi G. Chronic baroreflex activation effects on sympathetic nerve traffic, baroreflex function, and cardiac haemodynamics in heart failure: a proof-of-concept study. Eur J Heart Fail. 2014 Sep;16(9):977-83. doi: 10.1002/ejhf.138. Epub 2014 Jul 28. — View Citation

Gronda E, Seravalle G, Trevano FQ, Costantino G, Casini A, Alsheraei A, Lovett EG, Vanoli E, Mancia G, Grassi G. Long-term chronic baroreflex activation: persistent efficacy in patients with heart failure and reduced ejection fraction. J Hypertens. 2015 Aug;33(8):1704-8. doi: 10.1097/HJH.0000000000000603. — View Citation

Weaver FA, Abraham WT, Little WC, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Madershahian N, Muller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Zile MR. Surgical Experience and Long-term Results of Baroreflex Activation Therapy for Heart Failure With Reduced Ejection Fraction. Semin Thorac Cardiovasc Surg. 2016 Summer;28(2):320-328. doi: 10.1053/j.semtcvs.2016.04.017. Epub 2016 Jun 2. — View Citation

Zile MR, Abraham WT, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Muller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Little WC. Baroreflex activation therapy for the treatment of heart failure with a reduced ejection fraction: safety and efficacy in patients with and without cardiac resynchronization therapy. Eur J Heart Fail. 2015 Oct;17(10):1066-74. doi: 10.1002/ejhf.299. Epub 2015 Jun 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in New York Heart Association Functional Classification at 6 months Post-Implant	To demonstrate that that treatment with BAROSTIM NEO improves New York Heart Association classification.	Baseline, 6 months post-implant
Primary	Change in Six Minute Hall Walk from Baseline to 6 months Post-Implant	To demonstrate that that treatment with BAROSTIM NEO improves six-minute hall walk performance.	Baseline, 6 months post-implant
Primary	Left Ventricular Mass Index Change from Baseline to 6 Months Post-Implant	To demonstrate that that treatment with BAROSTIM NEO reduces left ventricular mass index.	Baseline, 6 months post-implant
Primary	Change in Biomarkers from Baseline to 6 months Post-Implant (e.g. NT-pro BNP, eGFR, Troponin HsT, Cystatin C)	To demonstrate that that treatment with BAROSTIM NEO improves biomarker results.	Baseline, 6 months post-implant
Primary	Number of Hospitalizations over Follow-Up	To demonstrate that that treatment with BAROSTIM NEO reduces hospitalizations.	12 months post-implant