Study Stopped
Lack of enrollment
Symptomatic CRT Patients: Real-World Experience - Barostim™ Advancing the Level of Clinical Evidence
1 other identifier
observational
5
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2023
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2023
CompletedFirst Posted
Study publicly available on registry
May 16, 2023
CompletedStudy Start
First participant enrolled
July 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 4, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 11, 2024
CompletedApril 8, 2025
April 1, 2025
1.1 years
April 18, 2023
April 4, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Six Minute Hall Walk
Changes in Six Minute Hall Walk distance through 36 months post-implant
36 months post-implant
Secondary Outcomes (2)
Change in Minnesota Living with Heart Failure Quality of Life
6 months post-implant
Change NYHA Class
6 months post-implant
Study Arms (1)
Device: Barostim™ System
Implantation of the Barostim™ System
Interventions
Eligibility Criteria
Heart failure patients who have been implanted with a CRT device and are planned for a de novo Barostim System implantation.
You may qualify if:
- 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.
You may not qualify if:
- Patients cannot be enrolled and active in another (e.g. device, pharmaceutical, or biological) clinical study unless approved by the CVRx Clinical department.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CVRx, Inc.lead
Study Sites (3)
Aurora Denver Cardiology Associates
Aurora, Colorado, 80012, United States
Florida Heart Rhythm Specialists
Fort Lauderdale, Florida, 33308, United States
Advanced Cardiology
Hackettstown, New Jersey, 07840, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 36 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2023
First Posted
May 16, 2023
Study Start
July 25, 2023
Primary Completion
September 4, 2024
Study Completion
December 11, 2024
Last Updated
April 8, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share