BridgeMD
New treatment option for HFrEF - Heart Failure With Reduced Ejection Fraction
Official title Impact of Barostimulation on Hemodynamics in Adults With Heart Failure
ClinicalTrials.gov ID: NCT07335510
What this study is testing
- What it's testing
- This study evaluates the effects of the implantation and adjustment of the CVRx Barostim device in adult patients with heart failure with reduced ejection fraction who are receiving maximally tolerated doses of guideline directed medical and device therapies. The study aims to assess how therapy using this device affects heart function, symptoms, and exercise capacity, with particular focus on how the device affects blood flow and heart pressures during exercise.
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
- Diagnosis of heart failure with reduced ejection fraction (defined as ejection fraction ≤ 35% for the purposes of this study) (should be within 12...
- Symptoms consistent with one of:
- current New York Heart Association (NYHA) Class III or
- current NYHA Class II and historical NYHA Class III
- Laboratories with last N-terminal pro-B-type natriuretic peptide (NT-proBNP) \< 1600 pg/ml (should be within 3 months of screen)
You likely can't join if
- Age \< 18 years
- Myocardial infarction (MI), syncope, cerebrovascular accident (CVA), aborted sudden cardiac death (SCD) (and implantable cardioverter defibrillator...
- Bilateral carotid bifurcations located above the level of the mandible
- Carotid artery stenosis greater than 50% caused by atherosclerosis
- Ulcerative plaques in the carotid artery
- Baroreflex failure or autonomic neuropathy
See the full eligibility criteria
- Diagnosis of heart failure with reduced ejection fraction (defined as ejection fraction ≤ 35% for the purposes of this study) (should be within 12 months of screen)
- Symptoms consistent with one of:
- current New York Heart Association (NYHA) Class III or
- current NYHA Class II and historical NYHA Class III
- Laboratories with last N-terminal pro-B-type natriuretic peptide (NT-proBNP) \< 1600 pg/ml (should be within 3 months of screen)
- Management with maximally-tolerated GDMT medications and devices
- Age \>= 18 years
- Age \< 18 years
- Myocardial infarction (MI), syncope, cerebrovascular accident (CVA), aborted sudden cardiac death (SCD) (and implantable cardioverter defibrillator (ICD) therapy) within 3 months of screening
- Bilateral carotid bifurcations located above the level of the mandible
- Carotid artery stenosis greater than 50% caused by atherosclerosis
- Ulcerative plaques in the carotid artery
- Baroreflex failure or autonomic neuropathy
- Symptomatic un-controlled bradyarrhythmias
- Severe chronic lung disease
- Current treatment with inotropes
- Pacemaker or ICD within 3 months of screening
- Cardiac resynchronization therapy (CRT) devices within 6 months of screening or anticipated to be placed in the next 90 days following screening
- Prior surgery, radiation, endovascular stent in the carotid sinus
- History or consideration of solid organ transplantation
- History or consideration of left ventricular assist device (LVAD)
- Life expectancy \<1 year from time of screening
- Non-cardiovascular conditions interfering with 6MWT distance assessment
- Inability to fulfill protocol requirements
- Known allergy to silicone or titanium
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Washington D.C., District of Columbia, United States
- Chicago, Illinois, United States
- New York, New York, United States
- Charleston, South Carolina, 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 - 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?
Study sites include San Francisco, California, United States; Washington D.C., District of Columbia, United States; Chicago, Illinois, United States; New York, New York, United States; Charleston, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.