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BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04502316
Recruitment Status : Recruiting
First Posted : August 6, 2020
Last Update Posted : June 29, 2021
Sponsor:
Information provided by (Responsible Party):
CVRx, Inc.

Brief Summary:
The purpose of this registry is to provide additional evidence of the safety and benefit of BAROSTIM THERAPY in the commercial setting in patients with heart failure with reduced ejection fraction (HFrEF) that were recently implanted with the BAROSTIM NEO System.

Condition or disease Intervention/treatment
Heart Failure Device: BAROSTIM NEO™ System

Detailed Description:

Summary:

The CVRx BAROSTIM THERAPY in Heart Failure with Reduced Ejection Fraction (HFrEF) Registry includes patients who have been recently implanted with the BAROSTIM NEO System for heart failure. Up to 5,000 patients will be enrolled. Patients must be enrolled within 30 days after the implant. Data should be obtained from standard of care measurements taken prior to implant, at implant, and every six months after device implant, up to the 36-month visit at which time each patient will be exited from the registry.

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction: A Post-Market Registry With the BAROSTIM™ NEO System
Actual Study Start Date : June 26, 2020
Estimated Primary Completion Date : June 2028
Estimated Study Completion Date : June 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure


Intervention Details:
  • Device: BAROSTIM NEO™ System
    Implantation of the BAROSTIM NEO™ System


Primary Outcome Measures :
  1. Rate of serious adverse events related to the system or implant procedure [ Time Frame: 36 months post-implant ]
    Serious adverse events related to the system or implant procedure through 36 months post-implant


Secondary Outcome Measures :
  1. Number of heart failure hospitalizations [ Time Frame: 36 months post-implant ]
    Number of heart failure hospitalizations through 36 months post-implant

  2. Duration of heart failure hospitalizations [ Time Frame: 36 months post-implant ]
    Duration of heart failure hospitalizations through 36 months post-implant

  3. Change NYHA Classification [ Time Frame: 36 months post-implant ]
    Changes in NYHA Classification through 36 months post-implant

  4. Change in NT-proBNP [ Time Frame: 36 months post-implant ]
    Changes in NT-proBNP through 36 months post-implant

  5. Change in LVEF [ Time Frame: 36 months post-implant ]
    Changes in LVEF through 36 months post-implant

  6. Rate of arrhythmias [ Time Frame: 36 months post-implant ]
    Number and/or treatment of arrhythmias through 36 months post-implant



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
The CVRx BAROSTIM THERAPY in Reduced Ejection Fraction (HFrEF) Registry will be performed in patients with heart failure with reduced ejection fraction (HFrEF) that were recently implanted with the BAROSTIM NEO System.
Criteria

Inclusion Criteria:

  • Patients can be included in the registry if they were implanted in the past 30 days with a de novo BAROSTIM NEO System for the treatment of heart failure. Patients must sign an IRB approved informed consent form for the registry to participate.

Indications:

The BAROSTIM NEO System is indicated for the improvement of symptoms of heart failure - quality of life, six-minute hall walk and functional status, for patients who remain symptomatic despite treatment with guideline-directed medical therapy, are NYHA Class III or Class II (who had a recent history of Class III), have a left ventricular ejection fraction ≤ 35%, a NT-proBNP < 1600 pg/ml and excluding patients indicated for Cardiac Resynchronization Therapy (CRT) according to AHA/ACC/ESC guidelines.

Contraindications:

  • 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 greater than 50%
  • Ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation
  • Known allergy to silicone or titanium

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04502316


Contacts
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Contact: Elizabeth Galle 763-416-2876 lgalle@cvrx.com

Locations
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United States, Alabama
Grandview Medical Center Recruiting
Birmingham, Alabama, United States, 35243
Contact: Brandy Parker    205-971-7495    brandy_parker@grandviewhealth.com   
Principal Investigator: Anil Rajendra         
United States, Arizona
Chan Heart Rhythm Institute Recruiting
Mesa, Arizona, United States, 85206
Contact: Sandi Hinojos    480-378-2440    sandi@chanheartrhythm.com   
Principal Investigator: Rodrigo Chan         
United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Melissa Ramos    323-442-7983    Melissa.Ramos@med.usc.edu   
Principal Investigator: Michael Fong         
United States, Florida
Orlando Heart and Vascular Institute Recruiting
Altamonte Springs, Florida, United States, 32714
Contact: Heather Boone    407-767-7023    hbooone@heartorlando.com   
Principal Investigator: Nandkishore Ranadive         
Cardiac Care Group Recruiting
Cape Coral, Florida, United States, 33914
Contact: Anthony Giordano    239-574-8463    tgiordano@flccg.com   
Principal Investigator: Joseph Freedman         
Naples Heart Rhythm Specialists, PA Recruiting
Naples, Florida, United States, 34119
Contact: Jori Richardson    239-263-0849    jrichardson@naplesheartrhytm.com   
Principal Investigator: Kenneth Plunkett         
AdventHealth Orlando Recruiting
Orlando, Florida, United States, 32803
Contact: Millie Lopez    407-303-1578    millie.lopez@adventhealth.com   
Principal Investigator: Hector Lozano         
United States, Nevada
Nevada Heart and Vascular Center Recruiting
Las Vegas, Nevada, United States, 89118
Contact: Alicia Bracken    702-333-7273    aliciab@nevadaheart.com   
Principal Investigator: Sanjay Malhorta         
United States, New Jersey
DeGregorio Cardiology Recruiting
Glen Ridge, New Jersey, United States, 07028
Contact: Asad Cheema    973-743-1121    asadmc@hotmail.com   
Principal Investigator: Asad Cheema         
Sponsors and Collaborators
CVRx, Inc.
Investigators
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Study Chair: Thomas Deering Piedmont Heart Institute
Study Chair: Bradley Knight Northwestern Medicine
Study Chair: Larry Chinitz NYU Heart Rhythm Center
Study Chair: Michael Gold Medical University of South Carolina
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Responsible Party: CVRx, Inc.
ClinicalTrials.gov Identifier: NCT04502316    
Other Study ID Numbers: 360059-001
First Posted: August 6, 2020    Key Record Dates
Last Update Posted: June 29, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases