Real-World Experience - Barostim™ Advancing the Level of Clinical Evidence (REBALANCE Registry)
Заболявания:
Heart Failure
Спонсор: CVRx, Inc.
Налично на:
БГ
Обобщение
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.
Описание
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.
Кой може да участва
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
Интервенции
Barostim™ System
DEVICE
Места на провеждане
46
САЩ (46)
Capital Cardiology
Albany , New York
Orlando Cardiac & Vascular Specialists
Altamonte Springs , Florida
Orlando Heart and Vascular Institute
Altamonte Springs , Florida
Aurora Denver Cardiology Associates
Aurora , Colorado
Austin Heart
Austin , Texas
Sinai Hospital of Baltimore
Baltimore , Maryland
Grandview Medical Center
Birmingham , Alabama
Lakewood Cardiovascular
Bradenton , Florida
AMA Heart and Vascular
Bradenton , Florida
Cardiovascular Solutions Institute
Bradenton , Florida
Cardiac Care Group
Cape Coral , Florida
University of Chicago
Chicago , Illinois
Baylor Scott & White Research Institute
Dallas , Texas
Daytona Heart Group
Daytona Beach , Florida
Florida Heart Rhythm Specialists
Fort Lauderdale , Florida
Stern Cardiovascular
Germantown , Tennessee
DeGregorio Cardiology
Glen Ridge , New Jersey
Cone Health
Greensboro , North Carolina
HeartPlus Diagnostic Center
Jackson , Mississippi
First Coast Cardiovascular Institute
Jacksonville , Florida
Marian David, M.D., P.C
Kew Gardens , New York
Capitol Cardiology Associates
Lanham , Maryland
South Denver Cardiology Associates, P.C.
Littleton , Colorado
Centra Heart & Vascular Institute
Lynchburg , Virginia
Premier Cardiology & Vascular Associates
Maitland , Florida
Carient Heart & Vascular
Manassas , Virginia
Adam Budzikowski PC
Maspeth , New York
Chan Heart Rhythm Institute
Mesa , Arizona
University of Miami
Miami , Florida
Medical College of Wisconsin
Milwaukee , Wisconsin
Cardiovascular Medicine
Moline , Illinois
Naples Heart Rhythm Specialists, PA
Naples , Florida
AdventHealth Orlando
Orlando , Florida
Cabrillo Cardiology Research Group
Oxnard , California
Advanced Cardiac Care
Ozone Park , New York
Akil Loli Consulting LLC
Phoenix , Arizona
Valley Hospital
Ridgewood , New Jersey
Sarasota Memorial Research Institute (Sarasota Memorial Hospital)
Sarasota , Florida
Cardio Vascular Health Associates
South River , New Jersey
University of South Florida
Tampa , Florida
COR Healthcare Medical Associates
Torrance , California
Howard T. Tee, M.D., F.A.C.C., F.A.C.P.
Vero Beach , Florida
Medstar Health Research Insitutute
Washington D.C. , District of Columbia
The George Washington University Medical Faculty Associates
Washington D.C. , District of Columbia
Marshfield Medical Center - Weston
Weston , Wisconsin
Florida Cardiology (Guardian Research Organization, LLC)
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