NCT07399587 Optimizing HFrEF Patients Using BaroStim and CardioMems
| NCT ID | NCT07399587 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Northwell Health |
| Condition | Heart Failure NYHA Class III |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-01-17 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 15 participants in total. It began in 2025-01-17 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
John Kassotis, MD
PRINCIPAL INVESTIGATOR
Northwell Health
Frequently Asked Questions
Who can join the NCT07399587 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Heart Failure NYHA Class III. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07399587 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07399587 currently recruiting?
Yes, NCT07399587 is actively recruiting participants. Contact the research team at ssrivastava3@northwell.edu for enrollment information.
Where is the NCT07399587 trial being conducted?
This trial is being conducted at Riverhead, United States.
Who is sponsoring the NCT07399587 clinical trial?
NCT07399587 is sponsored by Northwell Health. The principal investigator is John Kassotis, MD at Northwell Health. The trial plans to enroll 15 participants.
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