Heart Failure study: Barostim System
Official title Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure
ClinicalTrials.gov ID: NCT07232030
What this study is testing
- What it's testing
- The study will check if the Barostim system is safe and can lower death and serious heart‑failure events compared with standard medical care.
- Who it's for
- Adults with heart failure classified as NYHA class II or III, left‑ventricular ejection fraction under 50%, NT‑proBNP under 5,000 pg/mL, and already on guideline‑directed medicines.
- What's involved
- Participants will have a Barostim device implanted to deliver baroreflex activation therapy and will continue their usual heart‑failure medicines, with regular check‑ups and tests to track safety and outcomes.
- Time commitment
- Participants are followed for up to several years with periodic clinic visits and assessments.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age 18 years or above
- NYHA Functional Class II or III heart failure symptoms at the time of screening
- Left ventricular ejection fraction \< 50% within 6 months of consent
- Screening local lab NT-proBNP ≥ 400 AND \< 5,000 pg/mL or a BNP ≥100 AND \< 1,250 pg/mL, adjusted for BMI in a stable outpatient setting OR
- A documented Worsening Heart Failure Event in the 6 months prior to or concurrent with consent, AND an NT-proBNP \< 5,000 pg/mL or BNP \< 1,250...
You likely can't join if
- Any contraindications to Barostim as noted in Instructions for Use.
- An existing device which contraindicates Barostim specifically or unipolar therapy in general.
- AHA/ACC Stage D heart failure.
- Two or more NT-proBNP results \>5,000 pg/mL or BNP \>1,250 pg/mL in a stable outpatient setting within 3 months prior to consent.
- Current or prior continuous or intermittent intravenous positive inotrope therapy.
- Has received, is receiving, or scheduled to receive LVAD therapy.
See the full eligibility criteria
Who can join
- Age 18 years or above
- NYHA Functional Class II or III heart failure symptoms at the time of screening
- Left ventricular ejection fraction \< 50% within 6 months of consent
- Screening local lab NT-proBNP ≥ 400 AND \< 5,000 pg/mL or a BNP ≥100 AND \< 1,250 pg/mL, adjusted for BMI in a stable outpatient setting OR
- A documented Worsening Heart Failure Event in the 6 months prior to or concurrent with consent, AND an NT-proBNP \< 5,000 pg/mL or BNP \< 1,250 pg/mL, adjusted for BMI in a stable outpatient setting.
- No more than a 100% increase or a 50% decrease of the dosage of any one medication other than an oral diuretic.
- Medication changes within a drug class are allowed as long as the equivalent dosage is within the limits specified above.
- Unrestricted changes in oral diuretics are allowed.
- For participants with LVEF between 40-50%, SGLT2 inhibitors and mineralocorticoid receptor antagonists (MRAs) are encouraged and should be initiated before consent when possible.
- Six-minute hall walk (6MHW) ≥ 100 m AND ≤ 450 m within 15 days after consent.
- If female and of childbearing potential, must have a negative pregnancy test within 15 days after consent.
- Be an appropriate candidate for the trial and the surgical procedure as determined by the investigator or designee and the surgeon.
- Have signed an informed consent form for participation in this trial.
What rules you out
- Any contraindications to Barostim as noted in Instructions for Use.
- An existing device which contraindicates Barostim specifically or unipolar therapy in general.
- AHA/ACC Stage D heart failure.
- Two or more NT-proBNP results \>5,000 pg/mL or BNP \>1,250 pg/mL in a stable outpatient setting within 3 months prior to consent. If participant is taking sacubitril/valsartan (i.e.
- Current or prior continuous or intermittent intravenous positive inotrope therapy.
- Has received, is receiving, or scheduled to receive LVAD therapy.
- Solid organ or hematologic transplant or currently being evaluated for cardiac transplant.
- Serum estimated glomerular filtration rate (eGFR) \< 20 mL/min/1.73 m2 or has end-stage renal disease.
- Recurring symptomatic hypotension.
- Life expectancy less than one year.
- Has received or is receiving chronic dialysis.
- Is within WHO groups 1, 3, 4, or 5 pulmonary hypertension.
- Severe COPD or severe restrictive lung disease requiring chronic oral steroid use or any oxygen use.
- Heart failure secondary to a reversible cause, such as cardiac structural valvular disease, acute myocarditis and pericardial constriction.
- Active malignancy with the exception of non-melanoma skin cancers.
- Infiltrative cardiomyopathy (e.g. cardiac amyloidosis).
- Any other serious medical condition that may adversely affect the safety of the participant or validity of the trial, in the opinion of the investigator.
- Myocardial infarction
- Unstable angina
- Percutaneous coronary intervention (e.g. PTCA)
- Cerebral vascular accident or transient ischemic attack
- Cardiac arrest
- Surgical cardiac intervention (e.g., CABG, cardiac ablation, valve replacement, CRT/ICD implantation, IPG battery replacements)
- Surgery planned to occur within 45 days of the Barostim implant procedure. This includes pacemaker or ICD implants or battery replacements.
- Enrolled and active in another clinical trial (e.g. device, pharmaceutical, or biological) unless approved by the CVRx Clinical Research department.
- Unable or unwilling to fulfill the Protocol medication compliance and follow-up requirements, for reasons including but not limited to an unresolved history of alcohol or substance abuse or psychiatric disorder.
The study team makes the final eligibility decision.
Where it is enrolling
- Mobile, Alabama, United States
- Los Angeles, California, United States
- Clearwater, Florida, United States
- Jacksonville, Florida, United States
- Orlando, Florida, United States
- Tallahassee, Florida, United States
- Tampa, Florida, United States
- Elk Grove Village, Illinois, United States
- Moline, Illinois, United States
- Indianapolis, Indiana, United States
- Boston, Massachusetts, United States
- Omaha, Nebraska, United States
- Cincinnati, Ohio, United States
- Sioux Falls, South Dakota, United States
- Chattanooga, Tennessee, United States
- Germantown, Tennessee, United States
- Tyler, Texas, United States
- Marshfield, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Mobile, Alabama, United States; Los Angeles, California, United States; Clearwater, Florida, United States; Jacksonville, Florida, United States; Orlando, Florida, United States; Tallahassee, Florida, United States and 12 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.