Heart Failure
Conditions
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.
Interventions
DEVICEBarostim™ System
Implantation of the Barostim™ System
Sponsors
CVRx, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Six Minute Hall Walk | 36 months post-implant | Changes in Six Minute Hall Walk distance through 36 months post-implant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Change NYHA Class | 6 months post-implant | Changes in NYHA Classification through 6 months post-implant |
Countries
United States
Outcome results
None listed