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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04502316
• Other study ID #: 360059-001
• Status: Recruiting
• Start date: June 26, 2020
• Est. completion date: June 2028

Study information

• Verified date: January 2023
• Source: CVRx, Inc.
• Contact: Elizabeth Galle
• Phone: 763-416-2876
• Email: lgalle[@]cvrx.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: June 2028
• Est. primary completion date: June 2028
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Barostim™ System
Implantation of the Barostim™ System

Locations

Country	Name	City	State
United States	Capital Cardiology	Albany	New York
United States	Orlando Heart and Vascular Institute	Altamonte Springs	Florida
United States	Grandview Medical Center	Birmingham	Alabama
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	DeGregorio Cardiology	Glen Ridge	New Jersey
United States	Marian David, M.D., P.C	Kew Gardens	New York
United States	Nevada Heart and Vascular Center	Las Vegas	Nevada
United States	University of Southern California	Los Angeles	California
United States	Carient Heart & Vascular	Manassas	Virginia
United States	Chan Heart Rhythm Institute	Mesa	Arizona
United States	Naples Heart Rhythm Specialists, PA	Naples	Florida
United States	Dr. Truong Duong a Medical Corporation	Norco	California
United States	AdventHealth Orlando	Orlando	Florida
United States	Cardiovascular Interventions	Orlando	Florida
United States	Cabrillo Cardiology Research Group	Oxnard	California
United States	Valley Hospital	Ridgewood	New Jersey
United States	Cardio Vascular Health Associates	S. River	New Jersey
United States	The George Washington University Medical Faculty Associates	Washington	District of Columbia
United States	Marshfield Medical Center - Weston	Weston	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
CVRx, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of serious adverse events related to the system or implant procedure	Serious adverse events related to the system or implant procedure through 36 months post-implant	36 months post-implant
Secondary	Number of heart failure hospitalizations	Number of heart failure hospitalizations through 36 months post-implant	36 months post-implant
Secondary	Duration of heart failure hospitalizations	Duration of heart failure hospitalizations through 36 months post-implant	36 months post-implant
Secondary	Change NYHA Classification	Changes in NYHA Classification through 36 months post-implant	36 months post-implant
Secondary	Change in NT-proBNP	Changes in NT-proBNP through 36 months post-implant	36 months post-implant
Secondary	Change in LVEF	Changes in LVEF through 36 months post-implant	36 months post-implant
Secondary	Change in Six Minute Hall Walk	Changes in Six Minute Hall Walk distance through 36 months post-implant	36 months post-implant