BAROSTIM THERAPY Improves Cardiac RemoDeling in Heart Failure

Recruiting

• Conditions: Heart failure; I50

• Registration Number: DRKS00013297
• Lead Sponsor: CVRx Incorporated

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

To be eligible for this study:
1. Signed Ethics Committee (EC) approved informed consent form.
2. Implanted with a de novo BAROSTIM NEO System within 30 days prior to consent, and implant met the CE-Mark approved indications and contraindications for BAROSTIM NEO in the treatment of heart failure:
• Indication: New York Heart Association (NYHA) functional Class III and left ventricular ejection fraction (LVEF) = 35% despite being treated with the appropriate heart failure guideline directed therapy.
• Contraindications for the implantation of the BAROSTIM NEO
o Bilateral carotid bifurcations located above the level of the mandible
o Baroreflex failure or autonomic neuropathy
o Uncontrolled, symptomatic cardiac bradyarrhythmias
o Carotid atherosclerosis that is determined by ultrasound or angiographic evaluation to be greater than 50%
o Ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation
3. BAROSTIM THERAPY has not yet been activated.
4. Age at least 21 years at the time of consent.

Exclusion Criteria

If any of the following criteria are met, subjects are not eligible for this study.
1. Received cardiac resynchronization therapy (CRT) within six months of activation, or is actively receiving CRT.
2. Currently have a Class I indication for a cardiac resynchronization therapy (CRT) device according to ESC guidelines for the treatment of congestive heart failure.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint:<br>To describe the rate of System Related Serious Adverse Events from device activation through the last follow-up visit at 12 months.<br>Primary Efficacy Endpoint - LVESVi:<br>To determine whether the BAROSTIM THERAPY produces a change in Left Ventricular End Systolic Volume Index (LVESVi) from baseline through 6 months of follow-up in subject implanted with the BAROSTIM NEO System.<br>

Secondary Outcome Measures

Name	Time	Method
To determine whether the BAROSTIM THERAPY produces a change in Left Ventricular Ejection Fraction (LVEF) from baseline through 6 months of follow-up in subject implanted with the BAROSTIM NEO System.<br>