RightFit
RecruitingPhase 2 / Phase 3

Optimizing HFrEF Patients Using BaroStim and CardioMems

Optimizing the Management of Patients With Heart Failure With Reduced Ejection Fraction Using BaroStim and CardioMems

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 months, 1 year

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Patients will be followed for 3 months after the CardioMems insertion before undergoing insertion of a Barostim."
  • "Patients will be followed for 1 year after insertion of Barostim."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study uses CardioMems, a device that measures pressure in a lung artery, to assess the BaroStim device. It is for adults ages 18–80 with heart failure whose hearts pump much less blood than normal. Patients have 3 months of medicine adjustments before BaroStim placement and are followed for 1 year afterward.

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. Patients will be followed for 3 months after the CardioMems insertion before undergoing insertion of a Barostim. Patients who have undergone a CardioMems, will be eligible for enrollment after 3 months of medication management and optimization. Patients will be followed for 1 year after insertion of Barostim.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Sign and date a form agreeing to join the study.
  • Be willing to follow all study steps and be available for the whole study.
  • Be 18–80 years old.
  • Have NYHA Class III heart failure, which limits everyday activity, and a heart pumping measure called LVEF below 35%.
  • Be able to take heart failure medicines by mouth while doses are adjusted.
  • Have had CardioMems and BaroStim devices placed as part of usual care.
  • If able to become pregnant, agree to use highly effective birth control during the study and indefinitely afterward. Some heart failure medicines can harm an unborn baby.

Who can't join

  • Cannot receive CardioMems or BaroStim, or have known allergies to materials used for device placement or to recommended heart failure medicines.
  • Have an NT-proBNP blood test result above 1600 mg/dL, or need a CRT-D device, which helps coordinate heartbeats and treats dangerous rhythms, because of left bundle branch block.
  • Walk less than 140 meters in the first 6-minute walk test.
  • Have an LVAD, a pump that helps the heart, or have had a procedure on a carotid artery in the neck.
  • Are pregnant or breastfeeding, or had an illness with fever within 30 days before joining.
  • Received another experimental drug or treatment within 1 year, or currently smoke or used tobacco within 1 year.
  • Are in another study funded by CVRx.
  • Are considered a vulnerable person under the study rules. The provided text does not explain who this includes.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, ages 18-80 years 4. Diagnosed with NYHA Class III Heart Failure with LVEF\<35% 5. Able to tolerate oral medications for guideline directed medical therapy titration period 6. Have undergone insertion of CardioMems and BaroStim devices per standard of care. 7. 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 GDMT during pregnancy may reverse the positive remodeling and lead to life threatening worsening of heart failure. Women of child-bearing age need to agree to use such a method during study participation and indefinitely after the end of the study. Exclusion Criteria: 1. Individuals ineligible for either CardioMems or BaroStim devices. 2. NT-proBNP \>1600 mg/dL 3. Indicated for CRT-D device (left bundle branch block) 4. Initial 6-minute walk test distance less than 140 m 5. Left ventricular assist device (LVAD) 6. History of carotid vascular procedure (carotid endarterectomy) 7. Pregnancy or lactation 8. Known allergic reactions to components of the BaroStim or CardioMems insertion or guideline directed medical therapy for heart failure 9. Febrile illness within 30 days of study enrollment 10. Treatment with another investigational drug or other intervention within 1 year 11. Current smoker or tobacco use within 1 year 12. Enrolled in any other CVRx funded study, including investigator-initiated research, registries, or other pre- or post-market studies. 13. Vulnerable individuals as outlined below

Study sites (1)

NY