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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05860348
• Other study ID #: 360059-002
• Status: Recruiting
• Start date: November 2023
• Est. completion date: May 2028

Study information

• Verified date: October 2023
• Source: CVRx, Inc.
• Contact: Elizabeth Galle
• Phone: 763-416-2876
• Email: lgalle[@]cvrx.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 2028
• Est. primary completion date: May 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Barostim™ System
Implantation of the Barostim™ System

Locations

Country	Name	City	State
United States	Florida Heart Rhythm Specialists	Fort Lauderdale	Florida

Sponsors (1)

Lead Sponsor	Collaborator
CVRx, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Six Minute Hall Walk	Changes in Six Minute Hall Walk distance through 36 months post-implant	36 months post-implant
Secondary	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
Secondary	Change NYHA Class	Changes in NYHA Classification through 6 months post-implant	6 months post-implant