Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New device combo aims to ease heart failure burden

NCT ID NCT07399587

Disease control Sponsor: Northwell Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests if using two devices together can help people with advanced heart failure. Participants get a CardioMems sensor to monitor heart pressure and later a BaroStim device to regulate blood pressure. The goal is to improve symptoms, walking ability, and reduce hospital stays over one year.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Heart failure nyha class III are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

moderate heart failure systolic heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure nyha class III

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Peconic Bay Medical Center

    RECRUITING

    Riverhead, New York, 11901, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.