No phaseTerminated
BATwire Implant Kit Study
- Sponsor
- CVRx, Inc. (Industry)
- Enrolment
- 93 enrolled
- Conditions
- Heart Failure
- Interventions
- BATwire Implant Kit
- Ages
- adults, older adults
- Registry
- NCT04600791
Full record on ClinicalTrials.gov
From the registry
The purpose of this clinical investigation is to develop valid scientific evidence for the safety and effectiveness of the Barostim System delivered by the BATwire Implant Kit (BATwire Kit) in subjects with heart failure. Subjects may be enrolled if they meet the FDA approved PMA indication for use for the Barostim NEO or Barostim NEO2 device: Subjects who remain symptomatic despite treatment with guideline-directed medical therapy, are NYHA Class III or Class II (who had a recent history of Class III), have a left ventricular ejection fraction ≤ 35%, a NT-proBNP \< 1600 pg/ml and excludes patients indicated for Cardiac Resynchronization Therapy (CRT) according to AHA/ACC/ESC guidelines.
Primary outcomes
- Number of Participants Without Serious Adverse Events (SAEs) Related to the Implantation of the Lead Using the BATwire Implant Kit Through 30 Days Post-implant.
- Change in Six Minute Hall Walk (6MHW) Distance Walked
History
Results first posted
Last registry update
Study completion
Primary completion
Started
Registered