Trials / Terminated
TerminatedNCT05860348
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
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 5 (actual)
- Sponsor
- CVRx, Inc. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Barostim™ System | Implantation of the Barostim™ System |
Timeline
- Start date
- 2023-07-25
- Primary completion
- 2024-09-04
- Completion
- 2024-12-11
- First posted
- 2023-05-16
- Last updated
- 2025-04-08
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05860348. Inclusion in this directory is not an endorsement.