BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction
- Conditions
- Heart Failure
- Registration Number
- NCT02880618
- Lead Sponsor
- CVRx, Inc.
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Biomarkers from Baseline to 6 months Post-Implant (e.g. NT-pro BNP, eGFR, Troponin HsT, Cystatin C) Baseline, 6 months post-implant To demonstrate that that treatment with BAROSTIM NEO improves biomarker results.
Change in Six Minute Hall Walk from Baseline to 6 months Post-Implant Baseline, 6 months post-implant To demonstrate that that treatment with BAROSTIM NEO improves six-minute hall walk performance.
Change in New York Heart Association Functional Classification at 6 months Post-Implant Baseline, 6 months post-implant To demonstrate that that treatment with BAROSTIM NEO improves New York Heart Association classification.
Left Ventricular Mass Index Change from Baseline to 6 Months Post-Implant Baseline, 6 months post-implant To demonstrate that that treatment with BAROSTIM NEO reduces left ventricular mass index.
Number of Hospitalizations over Follow-Up 12 months post-implant To demonstrate that that treatment with BAROSTIM NEO reduces hospitalizations.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (30)
Herzzentrum Bad Oyenhausen
🇩🇪Bad Oeynhausen, Germany
Berlin Charité & Deutschen Herzzentrum Berlin
🇩🇪Berlin, Germany
Medizinisches Versorgungszentrum am Küchwald GmbH
🇩🇪Chemnitz, Germany
Lippe Klinikum
🇩🇪Detmold, Germany
Dresden Friedrichstadt
🇩🇪Dresden, Germany
Herzzentrum Dresden, Elektrophysiologie
🇩🇪Dresden, Germany
Herzzentrum Dresden - Interventionelle Kardiologie
🇩🇪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
Universitätsklinikum Schleswig-Holstein Campus Kiel
🇩🇪Kiel, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Kardiologie im Klinikum Ingolstadt
🇩🇪Ingolstadt, Germany
Universitätsklinikum Köln Herzzentrum
🇩🇪Köln, Germany
Herzentrum Lahr
🇩🇪Lahr, Germany
Universitätsklinikum Leipzig
🇩🇪Leipzig, Germany
Leipzig St. Georg
🇩🇪Leipzig, Germany
Universitätsklinik Mainz
🇩🇪Mainz, Germany
Clemenshospital Münster
🇩🇪Münster, Germany
Universitätsklinikum Regensburg
🇩🇪Regensburg, Germany
St. Vincenz-Krankenhaus
🇩🇪Paderborn, Germany
Marienkrankenhaus Siegen
🇩🇪Siegen, Germany
Krankenhaus & MVZ Maria-Hilf Stadtlohn GmbH
🇩🇪Stadtlohn, Germany
Klinikum Tuttlingen
🇩🇪Tuttlingen, Germany
Fondazione di Ricerca e Cura "Giovanni Paolo II"
🇮🇹Campobasso, Italy
Charité Campus Virchow Klinikum
🇩🇪Berlin, Germany
Immanuel Klinikum Bernau Herzzentrum Brandenburg
🇩🇪Bernau, Germany