BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction
HFrEF
1 other identifier
observational
500
2 countries
30
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2016
Longer than P75 for all trials
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2016
CompletedFirst Posted
Study publicly available on registry
August 26, 2016
CompletedStudy Start
First participant enrolled
December 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2024
CompletedApril 20, 2023
April 1, 2023
7.6 years
August 15, 2016
April 18, 2023
Conditions
Outcome Measures
Primary Outcomes (5)
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
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
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
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
Number of Hospitalizations over Follow-Up
To demonstrate that that treatment with BAROSTIM NEO reduces hospitalizations.
12 months post-implant
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CVRx, Inc.lead
Study Sites (30)
Herzzentrum Bad Oyenhausen
Bad Oeynhausen, 32545, Germany
Berlin Charité & Deutschen Herzzentrum Berlin
Berlin, 12203, Germany
Charité Campus Virchow Klinikum
Berlin, 13353, Germany
Immanuel Klinikum Bernau Herzzentrum Brandenburg
Bernau, 16321, Germany
Medizinisches Versorgungszentrum am Küchwald GmbH
Chemnitz, 09113, Germany
Universitätsklinikum Köln Herzzentrum
Cologne, 50937, Germany
Lippe Klinikum
Detmold, 32756, Germany
Dresden Friedrichstadt
Dresden, 01067, Germany
Herzzentrum Dresden - Interventionelle Kardiologie
Dresden, 01307, Germany
Herzzentrum Dresden, Elektrophysiologie
Dresden, 01307, Germany
Uniklinik Frankfurt
Frankfurt, 60590, Germany
Universitätsklinikum Gießen und Marburg
Giessen, 35392, Germany
Herzzentrum Göttingen
Göttingen, 37075, Germany
Albertinen-Krankenhaus
Hamburg, 22457, Germany
Asklepios Klinik Altona
Hamburg, 22763, Germany
St. Barbara Klinik Hamm
Hamm, 59073, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Kardiologie im Klinikum Ingolstadt
Ingolstadt, 85049, Germany
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel, 24105, Germany
Herzentrum Lahr
Lahr, 77933, Germany
Universitätsklinikum Leipzig
Leipzig, 04109, Germany
Leipzig St. Georg
Leipzig, 04129, Germany
Universitätsklinik Mainz
Mainz, 55131, Germany
Clemenshospital Münster
Münster, 48153, Germany
St. Vincenz-Krankenhaus
Paderborn, 33098, Germany
Universitätsklinikum Regensburg
Regensburg, 93053, Germany
Marienkrankenhaus Siegen
Siegen, 57072, Germany
Krankenhaus & MVZ Maria-Hilf Stadtlohn GmbH
Stadtlohn, 48970, Germany
Klinikum Tuttlingen
Tuttlingen, 78532, Germany
Fondazione di Ricerca e Cura "Giovanni Paolo II"
Campobasso, 86100, Italy
Related 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.
PMID: 25982108BACKGROUNDZile 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.
PMID: 26011593BACKGROUNDGronda 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.
PMID: 25067799BACKGROUNDGronda 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.
PMID: 26132760BACKGROUNDWeaver 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.
PMID: 28043438BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jochen Müller-Ehmsen, PhD
Asklepios Klinik Altona
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2016
First Posted
August 26, 2016
Study Start
December 13, 2016
Primary Completion
July 1, 2024
Study Completion
July 1, 2024
Last Updated
April 20, 2023
Record last verified: 2023-04