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New treatment option for Heart Failure NYHA Class III
Official title Optimizing HFrEF Patients Using BaroStim and CardioMems
ClinicalTrials.gov ID: NCT07399587
What this study is testing
- What it's testing
- The goal of this study is to utilize CardioMems (measurement of pulmonary artery diastolic pressure) to assess BaroStim. At the time of CardioMems insertion, patients will be screened for candidacy to receive a BaroStim device.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, ages 18-80 years
- Diagnosed with NYHA Class III Heart Failure with LVEF\<35%
- Able to tolerate oral medications for guideline directed medical therapy titration period
You likely can't join if
- Individuals ineligible for either CardioMems or BaroStim devices.
- NT-proBNP \>1600 mg/dL
- Indicated for CRT-D device (left bundle branch block)
- Initial 6-minute walk test distance less than 140 m
- Left ventricular assist device (LVAD)
- History of carotid vascular procedure (carotid endarterectomy)
See the full eligibility criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, ages 18-80 years
- Diagnosed with NYHA Class III Heart Failure with LVEF\<35%
- Able to tolerate oral medications for guideline directed medical therapy titration period
- Have undergone insertion of CardioMems and BaroStim devices per standard of care.
- It is a standard of care to recommend that females of reproductive potential use highly effective contraception, because of the teratogenic potential of many medications used to treat HFrEF. In addition, withdrawal of...
- Individuals ineligible for either CardioMems or BaroStim devices.
- NT-proBNP \>1600 mg/dL
- Indicated for CRT-D device (left bundle branch block)
- Initial 6-minute walk test distance less than 140 m
- Left ventricular assist device (LVAD)
- History of carotid vascular procedure (carotid endarterectomy)
- Pregnancy or lactation
- Known allergic reactions to components of the BaroStim or CardioMems insertion or guideline directed medical therapy for heart failure
- Febrile illness within 30 days of study enrollment
- Treatment with another investigational drug or other intervention within 1 year
- Current smoker or tobacco use within 1 year
- Enrolled in any other CVRx funded study, including investigator-initiated research, registries, or other pre- or post-market studies.
- Vulnerable individuals as outlined below
The study team makes the final eligibility decision.
Where it's taking place
- Riverhead, New York, 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 to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Riverhead, New York, 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.