Heart FailureNCT05860348
Symptomatic CRT Patients: Real-World Experience - Barostim™ Advancing the Level of Clinical Evidence
An observational study of Heart Failure, run by CVRx, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- What is being tested?
- Barostim™ System
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Jul 2023to 11 Dec 2024
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Heart failure patients who have been implanted with a CRT device and are planned for a de novo Barostim System implantation.
Who may be able to join
- 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 join
- Patients cannot be enrolled and active in another (e.g. device, pharmaceutical, or biological) clinical study unless approved by the CVRx Clinical department.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Aurora Denver Cardiology Associates
Aurora, Colorado, 80012
Florida Heart Rhythm Specialists
Fort Lauderdale, Florida, 33308
Advanced Cardiology
Hackettstown, New Jersey, 07840
About this study
Official title: Symptomatic CRT Patients: Real-World Experience - Barostim™ Advancing the Level of Clinical Evidence. A Post-Market Registry With the Barostim™ System
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.
Read the 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
- Heart Failure
- Being tested
- Barostim™ System
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barostim™ SystemDevice
Implantation of the Barostim™ System
| Study group | Role | What they receive |
|---|---|---|
| Device: Barostim™ System | Implantation of the Barostim™ System Receives: Device: Barostim™ System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Six Minute Hall Walk
Changes in Six Minute Hall Walk distance through 36 months post-implant
Measured: 36 months post-implant
Secondary outcomes (2)
Change in Minnesota Living with Heart Failure Quality of Life
Changes in Minnesota Living with Heart Failure Quality of Life through 6 months post-implant
Measured: 6 months post-implant
Change NYHA Class
Changes in NYHA Classification through 6 months post-implant
Measured: 6 months post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start25 Jul 2023
- Primary completion4 Sep 2024
- Study completion11 Dec 2024
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- CVRx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860348
- Sponsor's protocol ID
- 360064-001
- Status last verified
- Apr 2025
- First submitted
- 18 Apr 2023
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptomatic CRT Patients: Real-World Experience - Barostim™ Advancing the Level of Clinical Evidence. A Post-Market Registry With the Barostim™ System
- ClinicalTrials.gov ID
- NCT05860348
- Acronym / sponsor ID
- 360064-001
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- CVRx, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Jul 2023 (actual)
- Primary completion
- 4 Sep 2024 (actual)
- Study completion
- 11 Dec 2024 (actual)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device: Barostim™ System | – | Device: Barostim™ SystemImplantation of the Barostim™ System |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Heart failure patients who have been implanted with a CRT device and are planned for a de novo Barostim System implantation.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients cannot be enrolled and active in another (e.g. device, pharmaceutical, or biological) clinical study unless approved by the CVRx Clinical department.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Barostim™ SystemImplantation of the Barostim™ System | Device | Device: Barostim™ System |
Primary outcome
Change in Six Minute Hall Walk
Time frame: 36 months post-implant
Changes in Six Minute Hall Walk distance through 36 months post-implant
2 secondary outcomes
Change in Minnesota Living with Heart Failure Quality of Life
Time frame: 6 months post-implant
Change NYHA Class
Time frame: 6 months post-implant
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by CVRx, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Six Minute Hall Walk (time frame: 36 months post-implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.