BAROSTIM THERAPY™ In Heart Failure With Preserved Ejection Fraction

NCT02876042 | Unknown FDA Device

• 1 other identifier: 360047-001
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 13

Brief 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).

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in New York Heart Association Functional Classification

  Pre-implant baseline to 6 months post-implant

• Changes in Left Ventricular Mass Index

  Pre-implant baseline to 6 months post-implant

• Changes in LA volume index

  Pre-implant baseline to 6 months post-implant

• Changes in E/E' ratio

  Pre-implant baseline to 6 months post-implant

• Changes in NT-proBNP

  Pre-implant baseline, 6 months post-implant

Interventions

BAROSTIM NEO™ System DEVICE

Implantation of the BAROSTIM NEO™ System

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• CVRx, Inc.: lead

Study Sites (13)

Berlin Charité & Deutschen Herzzentrum Berlin

Berlin, 12203, Germany

ACTIVE NOT RECRUITING

Immanuel Klinikum Bernau Herzzentrum Brandenburg

Bernau, 16321, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum Köln Herzzentrum

Cologne, 50937, Germany

RECRUITING

Lippe Klinikum

Detmold, 32756, Germany

ACTIVE NOT RECRUITING

Uniklinik Frankfurt

Frankfurt, 60590, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum Gießen und Marburg

Giessen, 35392, Germany

RECRUITING

Herzzentrum Göttingen

Göttingen, 37075, Germany

ACTIVE NOT RECRUITING

Asklepios Klinik Altona

Hamburg, 22763, Germany

RECRUITING

Medizinische Hochschule Hannover

Hanover, 30625, Germany

ACTIVE NOT RECRUITING

Uniklinik Heidelberg

Heidelberg, 69120, Germany

RECRUITING

Kardiologie im Klinikum Ingolstadt

Ingolstadt, 85049, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum Regensburg

Regensburg, 93053, Germany

ACTIVE NOT RECRUITING

Marienkrankenhaus Siegen

Siegen, 57072, Germany

ACTIVE NOT RECRUITING

Related 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.

  PMID: 21300307 BACKGROUND

Related Links

• BAROSTIM THERAPY website

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Burkert Pieske, PhD

  Universitätmedizin Berlin - Charité

  STUDY CHAIR

Central Study Contacts

Elizabeth Galle

CONTACT

763-416-2876; lgalle@cvrx.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2016
• First Posted: August 23, 2016
• Study Start: March 23, 2017
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: April 20, 2023

Record last verified: 2023-04

Locations

DE (13)