Frontlight ResearchEarly access
TerminatedNo phase
Symptomatic CRT Patients: Real-World Experience - Barostim™ Advancing the Level of Clinical Evidence
Key facts
- Who runs it
- CVRx, Inc.
- Where
- Aurora, Fort Lauderdale, and Hackettstown, United StatesSee the 3 sites
- Trial code
- Status
- Terminated
- People taking part
- 5 people enrolled
- Started
- 25 Jul 2023
- Ended
- 11 Dec 2024
- Type of study
- Observational
- Treatments tested
- Barostim™ System
- Record updated
- 8 April 2025
- Why it stopped
- Lack of enrollment
Who can take part
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- 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
Who cannot take part
- Patients cannot be enrolled and active in another (e.g. device, pharmaceutical, or biological) clinical study unless approved by the CVRx Clinical department
Where in United States
- Aurora Denver Cardiology AssociatesAurora, United States
- Florida Heart Rhythm SpecialistsFort Lauderdale, United States
- Advanced CardiologyHackettstown, United States
About the trial
What the trial wants to find out
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.
The group in the trial
- Device: Barostim™ System
Implantation of the Barostim™ System
Treatment: Barostim™ System
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Symptomatic CRT Patients: Real-World Experience - Barostim™ Advancing the Level of Clinical Evidence. A Post-Market Registry With the Barostim™ System
- Record updated
- 8 April 2025