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

Last updated: April 4, 2025
Sponsor: CVRx, Inc.
Overall Status: Terminated

Phase

N/A

Condition

Chest Pain

Congestive Heart Failure

Hyponatremia

Treatment

Barostim™ System

Clinical Study ID

NCT05860348
360064-001
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 5
Treatment Group(s): 1
Primary Treatment: Barostim™ System
Phase:
Study Start date:
July 25, 2023
Estimated Completion Date:
December 11, 2024

Study 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.

Connect with a study center

  • Aurora Denver Cardiology Associates

    Aurora, Colorado 80012
    United States

    Site Not Available

  • Florida Heart Rhythm Specialists

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • Advanced Cardiology

    Hackettstown, New Jersey 07840
    United States

    Site Not Available

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