NCT02627196

Baroreflex Activation Therapy for Heart Failure

Barostim Neo® - Baroreflex Activation Therapy® for Heart Failure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,090 (actual)
• Sponsor: CVRx, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial (NCT02627196) is to develop valid scientific evidence for safety and effectiveness of Baroreflex Activation Therapy with the BAROSTIM NEO System in subjects with heart failure, defined as New York Heart Association (NYHA) functional Class III, left ventricular ejection fraction (LVEF) ≤ 35% and NT-proBNP\<1600 pg/ml despite being treated with the appropriate heart failure guideline directed therapy, excluding subjects eligible for or actively receiving Cardiac Resynchronization Therapy (CRT). The total trial duration is anticipated to be approximately 5 years; however, the duration of an individual subject enrollment will depend on when he or she entered the trial.

Detailed description

The BAROSTIM NEO - Baroreflex Activation Therapy for Heart Failure is a prospective, randomized trial in subjects with reduced ejection fraction heart failure. Subjects will be randomized in a 1:1 ratio to receive Barostim Activation Therapy with an implanted BAROSTIM NEO System in addition to medical management or to receive medical management alone (no device implant). The trial will be conducted at up to 120 investigational centers in the U.S. and up to 20 investigational centers outside the U.S. These centers will enroll up to 1200 subjects to randomize approximately 480 subjects who meet the entry criteria. For all subjects, trial visits will occur at 0.5, 1, 1.5, 2, 3, 6, 9 and 12 months post-implant (post anticipated implant for medical management). Visits will occur quarterly from 15 to 24 months and semi-annually thereafter. Subjects are followed in an identical manner regardless of trial arm. The data will provide evidence of the safety and efficacy of BAROSTIM THERAPY. The accumulated morbidity and mortality data collected will provide evidence of morbidity and mortality benefit. This trial will involve one or more interim analyses to evaluate when sufficient evidence is reached for the final morbidity and mortality analysis.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	BAROSTIM NEO® System
DRUG	Medical Management

Timeline

• Start date: 2016-04-19
• Primary completion: 2023-10-01
• Completion: 2023-10-01
• First posted: 2015-12-10
• Last updated: 2026-03-10
• Results posted: 2026-03-10

Locations

92 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated device study