Clinical trial NCT04502316: Real-World Experience - Barostim™ Advancing the Level of Clinical Evidence (REBALANCE Registry)
Official title: Real-World Experience -- Barostim™ Advancing the Level of Clinical Evidence (REBALANCE Registry) A Post-Market Registry With the Barostim™ System
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Heart Failure
Lead sponsor: CVRx, Inc.
Sponsor class: INDUSTRY
First posted: 2020-08-06
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients can be included in the registry if they were implanted with a de novo Barostim System.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of serious adverse events related to the system or implant procedure
timeFrame: 36 months post-implant
Secondary outcomes:
measure: Number of heart failure hospitalizations
timeFrame: 36 months post-implant
measure: Duration of heart failure hospitalizations
timeFrame: 36 months post-implant
measure: Change NYHA Classification
timeFrame: 36 months post-implant
measure: Change in NT-proBNP
timeFrame: 36 months post-implant
measure: Change in LVEF
timeFrame: 36 months post-implant
measure: Change in Six Minute Hall Walk
timeFrame: 36 months post-implant
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Grandview Medical Center
state: Alabama
city: Mesa
country: United States
facility: Chan Heart Rhythm Institute
state: Arizona
city: Phoenix
country: United States
facility: Akil Loli Consulting LLC
state: Arizona
city: Oxnard
country: United States
facility: Cabrillo Cardiology Research Group
state: California
city: Torrance
country: United States
facility: COR Healthcare Medical Associates
state: California
city: Aurora
country: United States
facility: Aurora Denver Cardiology Associates
state: Colorado
city: Littleton
country: United States
facility: South Denver Cardiology Associates, P.C.
state: Colorado
city: Washington
country: United States
facility: Medstar Health Research Insitutute
state: District of Columbia
city: Washington
country: United States
facility: The George Washington University Medical Faculty Associates
state: District of Columbia
city: Altamonte Springs
country: United States
facility: Orlando Cardiac & Vascular Specialists
state: Florida
city: Altamonte Springs
country: United States
facility: Orlando Heart and Vascular Institute
state: Florida
city: Bradenton
country: United States
facility: Lakewood Cardiovascular
state: Florida
city: Bradenton
country: United States
facility: AMA Heart and Vascular
state: Florida
city: Bradenton
country: United States
facility: Cardiovascular Solutions Institute
state: Florida
city: Cape Coral
country: United States
facility: Cardiac Care Group
state: Florida
city: Daytona Beach
country: United States
facility: Daytona Heart Group
state: Florida
city: Fort Lauderdale
country: United States
facility: Florida Heart Rhythm Specialists
state: Florida
city: Jacksonville
country: United States
facility: First Coast Cardiovascular Institute
state: Florida
city: Maitland
country: United States
facility: Premier Cardiology & Vascular Associates
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Naples
country: United States
facility: Naples Heart Rhythm Specialists, PA
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Research Institute (Sarasota Memorial Hospital)
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Vero Beach
country: United States
facility: Howard T. Tee, M.D., F.A.C.C., F.A.C.P.
state: Florida
city: Winter Park
country: United States
facility: Florida Cardiology (Guardian Research Organization, LLC)
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Moline
country: United States
facility: Cardiovascular Medicine
state: Illinois
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Lanham
country: United States
facility: Capitol Cardiology Associates
state: Maryland
city: Jackson
country: United States
facility: HeartPlus Diagnostic Center
state: Mississippi
city: Glen Ridge
country: United States
facility: DeGregorio Cardiology
state: New Jersey
city: Ridgewood
country: United States
facility: Valley Hospital
state: New Jersey
city: South River
country: United States
facility: Cardio Vascular Health Associates
state: New Jersey
city: Albany
country: United States
facility: Capital Cardiology
state: New York
city: Kew Gardens
country: United States
facility: Marian David, M.D., P.C
state: New York
city: Maspeth
country: United States
facility: Adam Budzikowski PC
state: New York
city: Ozone Park
country: United States
facility: Advanced Cardiac Care
state: New York
city: Greensboro
country: United States
facility: Cone Health
state: North Carolina
city: Germantown
country: United States
facility: Stern Cardiovascular
state: Tennessee
city: Austin
country: United States
facility: Austin Heart
state: Texas
city: Dallas
country: United States
facility: Baylor Scott & White Research Institute
state: Texas
city: Lynchburg
country: United States
facility: Centra Heart & Vascular Institute
state: Virginia
city: Manassas
country: United States
facility: Carient Heart & Vascular
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Weston
country: United States
facility: Marshfield Medical Center - Weston
state: Wisconsin
Study officials:
affiliation: Piedmont Heart Institute
name: Thomas Deering
role: STUDY_CHAIR
affiliation: Northwestern Medicine
name: Bradley Knight
role: STUDY_CHAIR
affiliation: NYU Heart Rhythm Center
name: Larry Chinitz
role: STUDY_CHAIR
affiliation: Medical University of South Carolina
name: Michael Gold
role: STUDY_CHAIR
References: