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NCT04502316Terminated

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

Source: ClinicalTrials.gov · Last updated 17 Sept 2026

Reason given: Participant follow-up through 12 months post-Barostim Implant sufficient for data collection and analysis purposes.

Brief summary (registry, in English)

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.

Status (registry)
Terminated
Study type
Observational
Enrollment
435 (actual)
First submitted
30 Jul 2020
Start date
26 Jun 2020
Primary completion date
14 May 2026
Lead sponsor
CVRx, Inc.
NCT number
NCT04502316

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • 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

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (46)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Capital CardiologyAlbanyUnited StatesUnknown status
Orlando Heart and Vascular InstituteAltamonte SpringsUnited StatesUnknown status
Orlando Cardiac & Vascular SpecialistsAltamonte SpringsUnited StatesUnknown status
Aurora Denver Cardiology AssociatesAuroraUnited StatesUnknown status
Austin HeartAustinUnited StatesUnknown status
Sinai Hospital of BaltimoreBaltimoreUnited StatesUnknown status
Grandview Medical CenterBirminghamUnited StatesUnknown status
AMA Heart and VascularBradentonUnited StatesUnknown status
Lakewood CardiovascularBradentonUnited StatesUnknown status
Cardiovascular Solutions InstituteBradentonUnited StatesUnknown status
Cardiac Care GroupCape CoralUnited StatesUnknown status
University of ChicagoChicagoUnited StatesUnknown status
Baylor Scott & White Research InstituteDallasUnited StatesUnknown status
Daytona Heart GroupDaytona BeachUnited StatesUnknown status
Florida Heart Rhythm SpecialistsFort LauderdaleUnited StatesUnknown status
Stern CardiovascularGermantownUnited StatesUnknown status
DeGregorio CardiologyGlen RidgeUnited StatesUnknown status
Cone HealthGreensboroUnited StatesUnknown status
HeartPlus Diagnostic CenterJacksonUnited StatesUnknown status
First Coast Cardiovascular InstituteJacksonvilleUnited StatesUnknown status
Marian David, M.D., P.CKew GardensUnited StatesUnknown status
Capitol Cardiology AssociatesLanhamUnited StatesUnknown status
South Denver Cardiology Associates, P.C.LittletonUnited StatesUnknown status
Centra Heart & Vascular InstituteLynchburgUnited StatesUnknown status
Premier Cardiology & Vascular AssociatesMaitlandUnited StatesUnknown status
Carient Heart & VascularManassasUnited StatesUnknown status
Adam Budzikowski PCMaspethUnited StatesUnknown status
Chan Heart Rhythm InstituteMesaUnited StatesUnknown status
University of MiamiMiamiUnited StatesUnknown status
Medical College of WisconsinMilwaukeeUnited StatesUnknown status
Cardiovascular MedicineMolineUnited StatesUnknown status
Naples Heart Rhythm Specialists, PANaplesUnited StatesUnknown status
AdventHealth OrlandoOrlandoUnited StatesUnknown status
Cabrillo Cardiology Research GroupOxnardUnited StatesUnknown status
Advanced Cardiac CareOzone ParkUnited StatesUnknown status
Akil Loli Consulting LLCPhoenixUnited StatesUnknown status
Valley HospitalRidgewoodUnited StatesUnknown status
Sarasota Memorial Research Institute (Sarasota Memorial Hospital)SarasotaUnited StatesUnknown status
Cardio Vascular Health AssociatesSouth RiverUnited StatesUnknown status
University of South FloridaTampaUnited StatesUnknown status
COR Healthcare Medical AssociatesTorranceUnited StatesUnknown status
Howard T. Tee, M.D., F.A.C.C., F.A.C.P.Vero BeachUnited StatesUnknown status
Medstar Health Research InsitututeWashington D.C.United StatesUnknown status
The George Washington University Medical Faculty AssociatesWashington D.C.United StatesUnknown status
Marshfield Medical Center - WestonWestonUnited StatesUnknown status
Florida Cardiology (Guardian Research Organization, LLC)Winter ParkUnited StatesUnknown status

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