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

CVRx

Status: Active, not recruiting

Conditions: Heart Failure

Treatments: Device: Barostim™ System

Study type: Observational

Funder types: Industry

Identifiers

NCT04502316

360059-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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