Symptomatic CRT Patients: Real-World Experience - Barostim™ Advancing the Level of Clinical Evidence

Terminated

• Conditions: Heart Failure
• Interventions: Device: Barostim™ System

• Registration Number: NCT05860348
• Lead Sponsor: CVRx, Inc.

Brief Summary

The purpose of this study is to develop valid scientific evidence of the safety and benefit of Barostim Therapy in the commercial setting in patients that are symptomatic despite having received CRT.

Detailed Description

This is a non-randomized, prospective, multicenter complementary-study of the REBALANCE Registry. Patients who have been implanted with a CRT device at least 6-months prior to enrollment are eligible for this complementary-study. Up to 150 subjects 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 study.

Study Timeline

• Study First Submitted: 2023-04-18
• Study First Submitted QC: 2023-05-05
• Study First Posted: 2023-05-16
• Study Start: 2023-07-25
• Primary Completion: 2024-09-04
• Study Completion: 2024-12-11
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Patients can be included if they were implanted with a cardiac resynchronization therapy (CRT) device at least six months (180 days) prior to informed consent and are planned for a de novo Barostim System implantation. Patients must sign an informed consent form before implantation with the Barostim System in order to participate in this study.

Exclusion Criteria

• Patients cannot be enrolled and active in another (e.g. device, pharmaceutical, or biological) clinical study unless approved by the CVRx Clinical department.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Device: Barostim™ System	Barostim™ System	Implantation of the Barostim™ System

Primary Outcome Measures

Name	Time	Method
Change in Six Minute Hall Walk	36 months post-implant	Changes in Six Minute Hall Walk distance through 36 months post-implant

Secondary Outcome Measures

Name	Time	Method
Change NYHA Class	6 months post-implant	Changes in NYHA Classification through 6 months post-implant
Change in Minnesota Living with Heart Failure Quality of Life	6 months post-implant	Changes in Minnesota Living with Heart Failure Quality of Life through 6 months post-implant

Trial Locations

Locations (3)

Aurora Denver Cardiology Associates; 🇺🇸 Aurora, Colorado, United States

Florida Heart Rhythm Specialists; 🇺🇸 Fort Lauderdale, Florida, United States

Advanced Cardiology; 🇺🇸 Hackettstown, New Jersey, United States