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ACTIVE NOT RECRUITING
NCT04502316

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

Sponsor: CVRx, Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

5000

Start Date

2020-06-26

Completion Date

2028-06

Last Updated

2026-02-10

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Barostim™ System

Implantation of the Barostim™ System

Locations (46)

Grandview Medical Center

Birmingham, Alabama, United States

Chan Heart Rhythm Institute

Mesa, Arizona, United States

Akil Loli Consulting LLC

Phoenix, Arizona, United States

Cabrillo Cardiology Research Group

Oxnard, California, United States

COR Healthcare Medical Associates

Torrance, California, United States

Aurora Denver Cardiology Associates

Aurora, Colorado, United States

South Denver Cardiology Associates, P.C.

Littleton, Colorado, United States

Medstar Health Research Insitutute

Washington D.C., District of Columbia, United States

The George Washington University Medical Faculty Associates

Washington D.C., District of Columbia, United States

Orlando Cardiac & Vascular Specialists

Altamonte Springs, Florida, United States

Orlando Heart and Vascular Institute

Altamonte Springs, Florida, United States

Lakewood Cardiovascular

Bradenton, Florida, United States

AMA Heart and Vascular

Bradenton, Florida, United States

Cardiovascular Solutions Institute

Bradenton, Florida, United States

Cardiac Care Group

Cape Coral, Florida, United States

Daytona Heart Group

Daytona Beach, Florida, United States

Florida Heart Rhythm Specialists

Fort Lauderdale, Florida, United States

First Coast Cardiovascular Institute

Jacksonville, Florida, United States

Premier Cardiology & Vascular Associates

Maitland, Florida, United States

University of Miami

Miami, Florida, United States

Naples Heart Rhythm Specialists, PA

Naples, Florida, United States

AdventHealth Orlando

Orlando, Florida, United States

Sarasota Memorial Research Institute (Sarasota Memorial Hospital)

Sarasota, Florida, United States

University of South Florida

Tampa, Florida, United States

Howard T. Tee, M.D., F.A.C.C., F.A.C.P.

Vero Beach, Florida, United States

Florida Cardiology (Guardian Research Organization, LLC)

Winter Park, Florida, United States

University of Chicago

Chicago, Illinois, United States

Cardiovascular Medicine

Moline, Illinois, United States

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

Capitol Cardiology Associates

Lanham, Maryland, United States

HeartPlus Diagnostic Center

Jackson, Mississippi, United States

DeGregorio Cardiology

Glen Ridge, New Jersey, United States

Valley Hospital

Ridgewood, New Jersey, United States

Cardio Vascular Health Associates

South River, New Jersey, United States

Capital Cardiology

Albany, New York, United States

Marian David, M.D., P.C

Kew Gardens, New York, United States

Adam Budzikowski PC

Maspeth, New York, United States

Advanced Cardiac Care

Ozone Park, New York, United States

Cone Health

Greensboro, North Carolina, United States

Stern Cardiovascular

Germantown, Tennessee, United States

Austin Heart

Austin, Texas, United States

Baylor Scott & White Research Institute

Dallas, Texas, United States

Centra Heart & Vascular Institute

Lynchburg, Virginia, United States

Carient Heart & Vascular

Manassas, Virginia, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Marshfield Medical Center - Weston

Weston, Wisconsin, United States