Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure (BENEFIT-HF)
New trial tests Barostim device to improve heart failure treatment
Plain English Summary
Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure is a Not Applicable clinical trial sponsored by CVRx, Inc. studying Heart Failure, Heart Failure NYHA Class II, Heart Failure NYHA Class III. This trial tests the Barostim System, a device that uses electrical signals to help the body's natural reflexes manage heart failure. It is for adults with moderate to severe heart failure who are already on standard medications and devices but still have symptoms. Participants will either receive the Barostim System implant or continue with their current usual care. The trial aims to see if the Barostim System can reduce deaths and hospitalizations related to heart failure compared to usual care. The trial aims to enroll 2500 participants.
Official Summary
The purpose of BENEFIT-HF is to demonstrate the safety and effectiveness of Baroreflex Activation Therapy (BAT) with the Barostim System in participants with heart failure, defined as NYHA Functional Class II or III, LVEF \< 50% and NT-proBNP \< 5,000 pg/mL despite being treated with Guideline-Directed Medical Therapies (medications and devices). It includes demonstration that treatment with the Barostim System, relative to usual care medical management, reduces the rate of all-cause mortality and Heart Failure Morbidity (Cardiac Transplant, Durable LVAD, or Worsening Heart Failure Events).
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 and older with heart failure symptoms (NYHA Class II or III). Individuals with a reduced ability of the heart to pump blood (LVEF < 50%) and specific blood marker levels. Patients must be on optimal standard heart failure medications and devices for at least 4 weeks. Those with very advanced heart failure, severe kidney problems, recent heart events, or certain other serious medical conditions cannot join. This trial is studying Heart Failure, Heart Failure NYHA Class II, Heart Failure NYHA Class III, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures will show if the Barostim System, compared to usual care, can reduce the risk of death from any cause or serious heart failure events like hospitalization or needing a tra The specific primary outcome measures are: Primary Effectiveness Endpoint (Through 24-months follow-up); Primary Safety Endpoint (Within 180 days of the device implant). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial addresses a significant unmet need in heart failure treatment by exploring a novel device-based therapy to improve outcomes for patients who haven't fully responded to current medical manag This research targets Heart Failure, Heart Failure NYHA Class II, Heart Failure NYHA Class III, where improved treatment options are needed.
Investor Insight
This trial, sponsored by CVRx, Inc., targets the large heart failure market and aims to demonstrate the value of Barostim as a treatment option, potentially improving its market position against exist The large enrollment target of 2500 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor if your current heart failure medications and devices are at their optimal levels. Understand that participation involves a surgical procedure to implant the Barostim device, followed by regular check-ups. Be prepared for potential follow-up visits and tests to monitor the device's function and your heart health. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 2,500 participants
Interventions
- DEVICE: Barostim System — Baroreflex Activation Therapy (BAT) using the Barostim System
- OTHER: Usual care medical management — Usual care medical management alone - no device implant
Primary Outcomes
- Primary Effectiveness Endpoint (Through 24-months follow-up)
- Primary Safety Endpoint (Within 180 days of the device implant)
Secondary Outcomes
- Quality of Life (QoL) Score Change (12-months follow-up)
- 6MHW distance change (12-months follow-up)
- Days lost to death or hospitalization (24-months follow-up)
- NT-proBNP level change (12-months follow up)
- All-cause mortality (24-months follow-up)
Trial Locations
- BayCare Health Systems, Tampa, Florida, United States
Frequently Asked Questions
What is clinical trial NCT07232030?
NCT07232030 is a Not Applicable INTERVENTIONAL study titled "Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure." It is currently recruiting and is sponsored by CVRx, Inc.. The trial targets enrollment of 2500 participants.
What conditions does NCT07232030 study?
This trial investigates treatments for Heart Failure, Heart Failure NYHA Class II, Heart Failure NYHA Class III. The primary condition under study is Heart Failure.
What treatments are being tested in NCT07232030?
The interventions being studied include: Barostim System (DEVICE), Usual care medical management (OTHER). Baroreflex Activation Therapy (BAT) using the Barostim System
What does Not Applicable mean for NCT07232030?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07232030?
This trial is currently "Recruiting." It started on 2026-04. The estimated completion date is 2033-01.
Who is sponsoring NCT07232030?
NCT07232030 is sponsored by CVRx, Inc.. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07232030?
The trial aims to enroll 2500 participants. The trial is currently recruiting and accepting new participants.
How is NCT07232030 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT07232030?
The primary outcome measures are: Primary Effectiveness Endpoint (Through 24-months follow-up); Primary Safety Endpoint (Within 180 days of the device implant). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07232030 being conducted?
This trial is being conducted at 1 site, including Tampa, Florida (United States).
Where can I find official information about NCT07232030?
The official record for NCT07232030 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07232030. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07232030 testing in simple terms?
This trial tests the Barostim System, a device that uses electrical signals to help the body's natural reflexes manage heart failure. It is for adults with moderate to severe heart failure who are already on standard medications and devices but still have symptoms.
Why is this trial significant?
This trial addresses a significant unmet need in heart failure treatment by exploring a novel device-based therapy to improve outcomes for patients who haven't fully responded to current medical manag
What are the potential risks of participating in NCT07232030?
The main risks involve surgery, including infection or bleeding, and potential issues with the implanted device. Some participants may experience side effects like low blood pressure, dizziness, or changes in heart rhythm. There's a possibility the device may not work as expected or could require adjustments. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07232030?
Ask your doctor if your current heart failure medications and devices are at their optimal levels. Understand that participation involves a surgical procedure to implant the Barostim device, followed by regular check-ups. Be prepared for potential follow-up visits and tests to monitor the device's function and your heart health. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07232030 signal from an investment perspective?
This trial, sponsored by CVRx, Inc., targets the large heart failure market and aims to demonstrate the value of Barostim as a treatment option, potentially improving its market position against exist This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will either receive the Barostim System implant or continue with their current usual care. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Heart Failure Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.