Clinical trial NCT02880618: BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction
Official title: BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction: A Post-Market Registry With the CE-Marked BAROSTIM NEO™ System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Lead sponsor: CVRx, Inc.
Sponsor class: INDUSTRY
First posted: 2016-08-26
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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).

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Change in New York Heart Association Functional Classification at 6 months Post-Implant
timeFrame: Baseline, 6 months post-implant
measure: Change in Six Minute Hall Walk from Baseline to 6 months Post-Implant
timeFrame: Baseline, 6 months post-implant
measure: Left Ventricular Mass Index Change from Baseline to 6 Months Post-Implant
timeFrame: Baseline, 6 months post-implant
measure: Change in Biomarkers from Baseline to 6 months Post-Implant (e.g. NT-pro BNP, eGFR, Troponin HsT, Cystatin C)
timeFrame: Baseline, 6 months post-implant
measure: Number of Hospitalizations over Follow-Up
timeFrame: 12 months post-implant
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Herzzentrum Bad Oyenhausen
city: Berlin
country: Germany
facility: Berlin Charité & Deutschen Herzzentrum Berlin
city: Berlin
country: Germany
facility: Charité Campus Virchow Klinikum
city: Bernau
country: Germany
facility: Immanuel Klinikum Bernau Herzzentrum Brandenburg
city: Chemnitz
country: Germany
facility: Medizinisches Versorgungszentrum am Küchwald GmbH
city: Detmold
country: Germany
facility: Lippe Klinikum
city: Dresden
country: Germany
facility: Dresden Friedrichstadt
city: Dresden
country: Germany
facility: Herzzentrum Dresden - Interventionelle Kardiologie
city: Dresden
country: Germany
facility: Herzzentrum Dresden, Elektrophysiologie
city: Frankfurt
country: Germany
facility: Uniklinik Frankfurt
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen und Marburg
city: Göttingen
country: Germany
facility: Herzzentrum Göttingen
city: Hamburg
country: Germany
facility: Albertinen-Krankenhaus
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
city: Hamm
country: Germany
facility: St. Barbara Klinik Hamm
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Ingolstadt
country: Germany
facility: Kardiologie im Klinikum Ingolstadt
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Campus Kiel
city: Köln
country: Germany
facility: Universitätsklinikum Köln Herzzentrum
city: Lahr
country: Germany
facility: Herzentrum Lahr
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Leipzig
country: Germany
facility: Leipzig St. Georg
city: Mainz
country: Germany
facility: Universitätsklinik Mainz
city: Münster
country: Germany
facility: Clemenshospital Münster
city: Paderborn
country: Germany
facility: St. Vincenz-Krankenhaus
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
city: Siegen
country: Germany
facility: Marienkrankenhaus Siegen
city: Stadtlohn
country: Germany
facility: Krankenhaus & MVZ Maria-Hilf Stadtlohn GmbH
city: Tuttlingen
country: Germany
facility: Klinikum Tuttlingen
city: Campobasso
country: Italy
facility: Fondazione di Ricerca e Cura "Giovanni Paolo II"
Study officials:
affiliation: Asklepios Klinik Altona
name: Jochen Müller-Ehmsen, PhD
role: STUDY_CHAIR
References:
citation: 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.
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.
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.
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.
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.