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Heart failure patients monitored in massive new registry

NCT ID NCT04502316

Disease control Sponsor: CVRx, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Updated 4 times

Summary

This study is a large registry that will follow 5,000 people with heart failure who have received a Barostim implant. The goal is to see how well the device works in everyday medical practice to improve symptoms and quality of life. Participants are already implanted and will be tracked over time to confirm the therapy's safety and benefits.

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.

Participants

435 people

The number who actually took part.

Started

Jun 2020

Finished

Jun 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Patients can be included in the registry if they were implanted with a de novo Barostim System.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Patients can be included in the registry if they were implanted with a de novo Barostim System. Patients must sign an informed consent form after implantation with the Barostim System in order to participate in the registry. Indications: The Barostim System is indicated for the improvement of symptoms of heart failure - quality of life, six-minute hall walk and functional status - for patients who remain symptomatic despite treatment with guideline-directed medical therapy, are NYHA Class III or Class II (who had a recent history of Class III), have a left ventricular ejection fraction ≤ 35%, a NT-proBNP \< 1600 pg/ml and excluding patients indicated for Cardiac Resynchronization Therapy (CRT) according to AHA/ACC/ESC guidelines. Contraindications: * Bilateral carotid bifurcations located above the level of the mandible * Baroreflex failure or autonomic neuropathy * Uncontrolled, symptomatic cardiac bradyarrhythmias * Carotid atherosclerosis that is determined by ultrasound or angiographic evaluation greater than 50% * Ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation * Known allergy to silicone or titanium

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Conditions

The condition(s) this trial relates to.

heart failure systolic heart failure

As listed by the trial registrant

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

Heart failure

Contacts and locations

Locations

  • AMA Heart and Vascular

    Bradenton, Florida, 34208, United States

  • Adam Budzikowski PC

    Maspeth, New York, 11378, United States

  • Advanced Cardiac Care

    Ozone Park, New York, 11416, United States

  • AdventHealth Orlando

    Orlando, Florida, 32803, United States

  • Akil Loli Consulting LLC

    Phoenix, Arizona, 85016, United States

  • Aurora Denver Cardiology Associates

    Aurora, Colorado, 80012, United States

  • Austin Heart

    Austin, Texas, 78756, United States

  • Baylor Scott & White Research Institute

    Dallas, Texas, 75246, United States

  • COR Healthcare Medical Associates

    Torrance, California, 90505, United States

  • Cabrillo Cardiology Research Group

    Oxnard, California, 93030, United States

  • Capital Cardiology

    Albany, New York, 12211, United States

  • Capitol Cardiology Associates

    Lanham, Maryland, 20706, United States

  • Cardiac Care Group

    Cape Coral, Florida, 33914, United States

  • Cardio Vascular Health Associates

    South River, New Jersey, 08882, United States

  • Cardiovascular Medicine

    Moline, Illinois, 61265, United States

  • Cardiovascular Solutions Institute

    Bradenton, Florida, 34209, United States

  • Carient Heart & Vascular

    Manassas, Virginia, 20109, United States

  • Centra Heart & Vascular Institute

    Lynchburg, Virginia, 24501, United States

  • Chan Heart Rhythm Institute

    Mesa, Arizona, 85206, United States

  • Cone Health

    Greensboro, North Carolina, 27401, United States

  • Daytona Heart Group

    Daytona Beach, Florida, 32114, United States

  • DeGregorio Cardiology

    Glen Ridge, New Jersey, 07028, United States

  • First Coast Cardiovascular Institute

    Jacksonville, Florida, 32256, United States

  • Florida Cardiology (Guardian Research Organization, LLC)

    Winter Park, Florida, 32792, United States

  • Florida Heart Rhythm Specialists

    Fort Lauderdale, Florida, 33308, United States

  • Grandview Medical Center

    Birmingham, Alabama, 35243, United States

  • HeartPlus Diagnostic Center

    Jackson, Mississippi, 39296, United States

  • Howard T. Tee, M.D., F.A.C.C., F.A.C.P.

    Vero Beach, Florida, 32960, United States

  • Lakewood Cardiovascular

    Bradenton, Florida, 34202, United States

  • Marian David, M.D., P.C

    Kew Gardens, New York, 11415, United States

  • Marshfield Medical Center - Weston

    Weston, Wisconsin, 54479, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Medstar Health Research Insitutute

    Washington D.C., District of Columbia, 20010, United States

  • Naples Heart Rhythm Specialists, PA

    Naples, Florida, 34119, United States

  • Orlando Cardiac & Vascular Specialists

    Altamonte Springs, Florida, 32701, United States

  • Orlando Heart and Vascular Institute

    Altamonte Springs, Florida, 32714, United States

  • Premier Cardiology & Vascular Associates

    Maitland, Florida, 32751, United States

  • Sarasota Memorial Research Institute (Sarasota Memorial Hospital)

    Sarasota, Florida, 34239, United States

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215, United States

  • South Denver Cardiology Associates, P.C.

    Littleton, Colorado, 80120, United States

  • Stern Cardiovascular

    Germantown, Tennessee, 38138, United States

  • The George Washington University Medical Faculty Associates

    Washington D.C., District of Columbia, 20037, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • University of South Florida

    Tampa, Florida, 33609, United States

  • Valley Hospital

    Ridgewood, New Jersey, 07450, United States

More trials for these conditions

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