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Tiny lung sensor could keep heart failure patients out of hospital

NCT ID NCT04398654

Disease control Sponsor: IHF GmbH - Institut für Herzinfarktforschung 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a small sensor implanted in the lung artery can help doctors remotely monitor heart failure and adjust treatments. About 554 patients with advanced heart failure will either receive standard care or the sensor plus standard care. The goal is to see if the sensor reduces hospitalizations and deaths over 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CardioMEMS HF sensor (implantable device for pulmonary artery pressure monitoring)
What this could lead to
If successful, this could provide a better way to manage heart failure remotely, reducing hospital visits and improving quality of life.
What could go wrong
This is a single study with 554 participants, and results may not apply to all heart failure patients. Device complications or sensor failure are possible risks.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 554 people

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

Started

Oct 2020

Expected to finish

Dec 2026

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 years and older

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. Written consent received from the patient or a legal representative after the in-formation has been provided. 2. ≥ 18 years of age. 3. Predominant symptoms in NYHA Stage III in the 30-day period prior to consent to the study. 4. Objectified HF diagnosis for more than three months. 5. Hospitalisation within 12 months prior to inclusion due to deterioration of HF symptoms. 6. Able to tolerate dual antiplatelet therapy or anticoagulation therapy for one month after sensor implantation 7. Patients with reduced left ventricular ejection fraction (LVEF) ≤40% (diagnosed within 6 months prior to inclusion) must be treated with guideline-compliant HF pharmacotherapy; if one class of guideline-compliant medication is not tolerated, appropriate documentation must be supplied; patients must receive and tolerate at least one class of guideline-compliant medication; if no guideline-compliant medication is tolerated at all, the patient may not participate in the study. 8. In patients with preserved LVEF (\>40%; diagnosed within 6 months prior to inclu-sion) comorbidities must be treated in accordance with guideline-compliant medi-cation. 9. Chest circumference (measured at axillary level) of less than 165 cm if BMI \>35 kg/m2. 10. Willing and mentally and physically able to meet the requirements for follow-up and long-term basic care (this includes the long-term willingness of the patient, and of their relatives where relevant, to participate in PA pressure-based monitor-ing). 11. Appropriate domestic situation, defined as being accessible by telephone (via fixed or mobile network) . Exclusion criteria: 1. Enrolment in another study with an active treatment arm. 2. Severe cardiovascular event (e.g. myocardial infarction, open heart surgery, stroke, CRT implantation) in the 2 months prior to admission 3. Therapy-refractory heart failure in ACC/AHA stage D or new therapies that have taken place or are planned in the next 12 months (e.g. implantation of a left ven-tricular assist system / transplantation) 4. Active infection. 5. History of recurrent (\>1 episode) pulmonary embolism and/or deep vein throm-bosis. 6. Continuous or intermittent chronic inotropic therapy. 7. Estimated glomerular filtration rate (eGFR) \<25 ml/min 8. Life expectancy (according to the study physician's assessment) \<12 months. 9. Severe, unrepaired congenital heart defect that would prevent implantation of the sensor. 10. Severe valve vitium with planned intervention in the next 3 months 11. Presence of a mechanical right heart valve. 12. Mental disorder that presumably (in the opinion of the study physician) has a negative impact on patient compliance or consent. 13. Failure of the coordinating physician to approve if the patient is enrolled in an HF disease management program or comparable case management program. 14. Women of childbearing age with a positive pregnancy test at the time of inclusion 15. For the intervention group: Preliminary investigations have shown that the diameter of the pulmonary artery branch intended for implantation is \<7 mm 16. The patient has private health insurance

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Conditions

The condition(s) this trial relates to.

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

  • BG Unfallkrankenhaus Berlin

    Berlin, Germany

  • Cardio Centrum Ludwigsburg-Bietigheim

    Ludwigsburg, Germany

  • Cardio Consil Rostock

    Rostock, Germany

  • Charité Universitätsmedizin (Campus Mitte, Campus Virchow, Campus Benjamin Franklin)

    Berlin, Germany

  • DHZC, Campus Virchow

    Berlin, Germany

  • Deutsches Zentrum für Herzinsuffizienz (DZHI)

    Würzburg, 97080, Germany

  • Helios Klinikum Erfurt

    Erfurt, Germany

  • Herz- und Diabeteszentrum NRW

    Bad Oeynhausen, Germany

  • Kerckhoff-Klinik Forschungs GmbH

    Bad Nauheim, Germany

  • Klinikum Bielefeld

    Bielefeld, Germany

  • Klinikum Coburg

    Coburg, Germany

  • Klinikum Fürth

    Fürth, Germany

  • Klinikum Karlsburg

    Karlsburg, Germany

  • Klinikum Oldenburg

    Oldenburg, Germany

  • Krankenhaus der Barmherzigen Brüder

    Trier, Germany

  • Leipzig Heart Institute GmbH

    Leipzig, Germany

  • Medizinische Hochschule Hannover

    Hanover, Germany

  • Praxis am Spreebogen

    Berlin, Germany

  • Praxisklinik Herz und Gefäße

    Dresden, Germany

  • Rems-Murr Klinikum

    Winnenden, Germany

  • SLK-Kliniken GmbH - Klinikum am Plattenwald

    Bad Friedrichshall, 74177, Germany

  • Sana Klinikum Lichtenberg

    Berlin, Germany

  • Schwarzwald-Baar Klinikum

    Villingen-Schwenningen, Germany

  • St Johannes Hospital Dortmund

    Dortmund, Germany

  • St. Elisabeth Krankenhaus, Contilia Herz- und Gefäßzentrum

    Essen, Germany

  • St. Georg Klinikum

    Eisenach, Germany

  • Universitäres Herz- und Gefäßzentrum Hamburg

    Hamburg, Germany

  • Universitäts-Herzzentrum Dresden

    Dresden, Germany

  • Universitätsklinikum Bonn

    Bonn, Germany

  • Universitätsklinikum Düsseldorf

    Düsseldorf, Germany

  • Universitätsklinikum Essen

    Essen, Germany

  • Universitätsklinikum Frankfurt

    Frankfurt, Germany

  • Universitätsklinikum Gießen

    Giessen, Germany

  • Universitätsklinikum Jena

    Jena, Germany

  • Universitätsklinikum Magdeburg

    Magdeburg, Germany

  • Westpfalz Klinikum

    Kaiserslautern, Germany

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