Real-World Experience - Barostim™ Advancing the Level of Clinical Evidence (REBALANCE Registry)

Real-World Experience -- Barostim™ Advancing the Level of Clinical Evidence (REBALANCE Registry) A Post-Market Registry With the Barostim™ System

The purpose of this registry is to develop valid scientific 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 System.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Device: Barostim™ System

Detailed Description

Summary:

The CVRx REBALANCE Registry includes patients who have been implanted with the Barostim System. Up to 5,000 patients will be enrolled. Data should be obtained from evaluations 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.

Enrollment data are collected retrospectively after consent and Barostim implant; post-enrollment data are collected prospectively from standard of care follow-up.

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35243
      • Grandview Medical Center
  • Arizona
    • Mesa, Arizona, United States, 85206
      • Chan Heart Rhythm Institute
    • Phoenix, Arizona, United States, 85016
      • Akil Loli Consulting LLC
  • California
    • Oxnard, California, United States, 93030
      • Cabrillo Cardiology Research Group
    • Torrance, California, United States, 90505
      • COR Healthcare Medical Associates
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Aurora Denver Cardiology Associates
    • Littleton, Colorado, United States, 80120
      • South Denver Cardiology Associates, P.C.
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Medstar Health Research Insitutute
    • Washington D.C., District of Columbia, United States, 20037
      • The George Washington University Medical Faculty Associates
  • Florida
    • Altamonte Springs, Florida, United States, 32714
      • Orlando Heart and Vascular Institute
    • Altamonte Springs, Florida, United States, 32701
      • Orlando Cardiac & Vascular Specialists
    • Bradenton, Florida, United States, 34202
      • Lakewood Cardiovascular
    • Bradenton, Florida, United States, 34208
      • AMA Heart and Vascular
    • Bradenton, Florida, United States, 34209
      • Cardiovascular Solutions Institute
    • Cape Coral, Florida, United States, 33914
      • Cardiac Care Group
    • Daytona Beach, Florida, United States, 32114
      • Daytona Heart Group
    • Fort Lauderdale, Florida, United States, 33308
      • Florida Heart Rhythm Specialists
    • Jacksonville, Florida, United States, 32256
      • First Coast Cardiovascular Institute
    • Maitland, Florida, United States, 32751
      • Premier Cardiology & Vascular Associates
    • Miami, Florida, United States, 33136
      • University of Miami
    • Naples, Florida, United States, 34119
      • Naples Heart Rhythm Specialists, PA
    • Orlando, Florida, United States, 32803
      • AdventHealth Orlando
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Research Institute (Sarasota Memorial Hospital)
    • Tampa, Florida, United States, 33609
      • University of South Florida
    • Vero Beach, Florida, United States, 32960
      • Howard T. Tee, M.D., F.A.C.C., F.A.C.P.
    • Winter Park, Florida, United States, 32792
      • Florida Cardiology (Guardian Research Organization, LLC)
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Moline, Illinois, United States, 61265
      • Cardiovascular Medicine
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Sinai Hospital of Baltimore
    • Lanham, Maryland, United States, 20706
      • Capitol Cardiology Associates
  • Mississippi
    • Jackson, Mississippi, United States, 39296
      • HeartPlus Diagnostic Center
  • New Jersey
    • Glen Ridge, New Jersey, United States, 07028
      • DeGregorio Cardiology
    • Ridgewood, New Jersey, United States, 07450
      • Valley Hospital
    • South River, New Jersey, United States, 08882
      • Cardio Vascular Health Associates
  • New York
    • Albany, New York, United States, 12211
      • Capital Cardiology
    • Kew Gardens, New York, United States, 11415
      • Marian David, M.D., P.C
    • Maspeth, New York, United States, 11378
      • Adam Budzikowski PC
    • Ozone Park, New York, United States, 11416
      • Advanced Cardiac Care
  • North Carolina
    • Greensboro, North Carolina, United States, 27401
      • Cone Health
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Stern Cardiovascular
  • Texas
    • Austin, Texas, United States, 78756
      • Austin Heart
    • Dallas, Texas, United States, 75246
      • Baylor Scott & White Research Institute
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • Centra Heart & Vascular Institute
    • Manassas, Virginia, United States, 20109
      • Carient Heart & Vascular
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin
    • Weston, Wisconsin, United States, 54479
      • Marshfield Medical Center - Weston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients can be included in the registry if they were implanted with a de novo Barostim System.

Description

Inclusion Criteria:

• Patients can be included in the registry if they were implanted with a de novo Barostim System. Patients must sign an informed consent form after implantation with the Barostim System in order to participate in the registry.

Indications:

The Barostim 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary objective of this post-market registry is to develop valid scientific evidence of the safety and benefit of Barostim Therapy in the commercial setting in patients that were recently implanted with the Barostim System.	36 months post-implant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of heart failure hospitalizations	Number of heart failure hospitalizations through 36 months post-implant	36 months post-implant
Duration of heart failure hospitalizations	Duration of heart failure hospitalizations through 36 months post-implant	36 months post-implant
Change NYHA Classification	Changes in NYHA Classification through 36 months post-implant	36 months post-implant
Change in NT-proBNP	Changes in NT-proBNP through 36 months post-implant	36 months post-implant
Change in LVEF	Changes in LVEF through 36 months post-implant	36 months post-implant
Change in Six Minute Hall Walk	Changes in Six Minute Hall Walk distance through 36 months post-implant	36 months post-implant

Collaborators and Investigators

• Sponsor: CVRx, Inc.
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2020
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: July 30, 2020
• First Submitted That Met QC Criteria: August 5, 2020
• First Posted (Actual): August 6, 2020

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 360059-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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