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

• Sponsor: CVRx, Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05860348
• Collaborator: (none)
• Enrollment: 150
• Anticipated Duration (Months): 60

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Symptomatic CRT Patients: Real-World Experience - Barostim™ Advancing the Level of Clinical Evidence. A Post-Market Registry With the Barostim™ System
• Anticipated Study Start Date: May 1, 2023
• Anticipated Primary Completion Date: May 1, 2028
• Anticipated Study Completion Date: May 1, 2028

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. Change NYHA Class [6 months post-implant]

   Changes in NYHA Classification through 6 months post-implant

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• CVRx, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CVRx, Inc.
• ClinicalTrials.gov Identifier: NCT05860348
• Other Study ID Numbers: 360059-002
• First Posted: May 16, 2023
• Last Update Posted: May 16, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of May 16, 2023