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
1 other identifier
observational
5,000
1 country
46
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2020
Longer than P75 for all trials
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 26, 2020
CompletedFirst Submitted
Initial submission to the registry
July 30, 2020
CompletedFirst Posted
Study publicly available on registry
August 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
May 5, 2026
April 1, 2026
7.9 years
July 30, 2020
April 29, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Interventions
Implantation of the Barostim™ System
Eligibility Criteria
Patients can be included in the registry if they were implanted with a de novo Barostim System.
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CVRx, Inc.lead
Study Sites (46)
Grandview Medical Center
Birmingham, Alabama, 35243, United States
Chan Heart Rhythm Institute
Mesa, Arizona, 85206, United States
Akil Loli Consulting LLC
Phoenix, Arizona, 85016, United States
Cabrillo Cardiology Research Group
Oxnard, California, 93030, United States
COR Healthcare Medical Associates
Torrance, California, 90505, United States
Aurora Denver Cardiology Associates
Aurora, Colorado, 80012, United States
South Denver Cardiology Associates, P.C.
Littleton, Colorado, 80120, United States
Medstar Health Research Insitutute
Washington D.C., District of Columbia, 20010, United States
The George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, 20037, United States
Orlando Cardiac & Vascular Specialists
Altamonte Springs, Florida, 32701, United States
Orlando Heart and Vascular Institute
Altamonte Springs, Florida, 32714, United States
Lakewood Cardiovascular
Bradenton, Florida, 34202, United States
AMA Heart and Vascular
Bradenton, Florida, 34208, United States
Cardiovascular Solutions Institute
Bradenton, Florida, 34209, United States
Cardiac Care Group
Cape Coral, Florida, 33914, United States
Daytona Heart Group
Daytona Beach, Florida, 32114, United States
Florida Heart Rhythm Specialists
Fort Lauderdale, Florida, 33308, United States
First Coast Cardiovascular Institute
Jacksonville, Florida, 32256, United States
Premier Cardiology & Vascular Associates
Maitland, Florida, 32751, United States
University of Miami
Miami, Florida, 33136, United States
Naples Heart Rhythm Specialists, PA
Naples, Florida, 34119, United States
AdventHealth Orlando
Orlando, Florida, 32803, United States
Sarasota Memorial Research Institute (Sarasota Memorial Hospital)
Sarasota, Florida, 34239, United States
University of South Florida
Tampa, Florida, 33609, United States
Howard T. Tee, M.D., F.A.C.C., F.A.C.P.
Vero Beach, Florida, 32960, United States
Florida Cardiology (Guardian Research Organization, LLC)
Winter Park, Florida, 32792, United States
University of Chicago
Chicago, Illinois, 60637, United States
Cardiovascular Medicine
Moline, Illinois, 61265, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
Capitol Cardiology Associates
Lanham, Maryland, 20706, United States
HeartPlus Diagnostic Center
Jackson, Mississippi, 39296, United States
DeGregorio Cardiology
Glen Ridge, New Jersey, 07028, United States
Valley Hospital
Ridgewood, New Jersey, 07450, United States
Cardio Vascular Health Associates
South River, New Jersey, 08882, United States
Capital Cardiology
Albany, New York, 12211, United States
Marian David, M.D., P.C
Kew Gardens, New York, 11415, United States
Adam Budzikowski PC
Maspeth, New York, 11378, United States
Advanced Cardiac Care
Ozone Park, New York, 11416, United States
Cone Health
Greensboro, North Carolina, 27401, United States
Stern Cardiovascular
Germantown, Tennessee, 38138, United States
Austin Heart
Austin, Texas, 78756, United States
Baylor Scott & White Research Institute
Dallas, Texas, 75246, United States
Centra Heart & Vascular Institute
Lynchburg, Virginia, 24501, United States
Carient Heart & Vascular
Manassas, Virginia, 20109, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54479, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2020
First Posted
August 6, 2020
Study Start
June 26, 2020
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2028
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share