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

Symptomatic CRT Patients: Real-World Experience - Barostim™ Advancing the Level of Clinical Evidence. A Post-Market Registry With the Barostim™ System

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.

Study Overview

• Status: Terminated
• Conditions: Heart Failure
• Intervention / Treatment: Device: Barostim™ System

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 Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Aurora Denver Cardiology Associates
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Florida Heart Rhythm Specialists
  • New Jersey
    • Hackettstown, New Jersey, United States, 07840
      • Advanced Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Heart failure patients who have been implanted with a CRT device and are planned for a de novo Barostim System implantation.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Device: Barostim™ System; Implantation of the Barostim™ System	Device: Barostim™ System; Implantation of the Barostim™ System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Six Minute Hall Walk	Changes in Six Minute Hall Walk distance through 36 months post-implant	36 months post-implant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Minnesota Living with Heart Failure Quality of Life	Changes in Minnesota Living with Heart Failure Quality of Life through 6 months post-implant	6 months post-implant
Change NYHA Class	Changes in NYHA Classification through 6 months post-implant	6 months post-implant

Collaborators and Investigators

• Sponsor: CVRx, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2023
• Primary Completion (Actual): September 4, 2024
• Study Completion (Actual): December 11, 2024

Study Registration Dates

• First Submitted: April 18, 2023
• First Submitted That Met QC Criteria: May 5, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 4, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 360064-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No