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New heart device aims to ease heart failure symptoms

NCT ID NCT03191656

Disease control Sponsor: Corvia Medical 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study is tracking 500 heart failure patients in Germany who receive a small device called the InterAtrial Shunt. The device is implanted to create a tiny passage between the heart's upper chambers, which may help lower pressure and improve breathing and quality of life. Researchers are collecting real-world data on safety and effectiveness.

What this could mean

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

Active substance
InterAtrial Shunt Device (IASD System II)
What this could lead to
If successful, this device could offer a new way to manage heart failure by reducing pressure in the heart, potentially improving symptoms and quality of life.
What could go wrong
This is an observational registry, not a randomized trial, so results may be less definitive. There are risks of device-related complications, and the device is already approved in the EU, so this study is for further confirmation.

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

About 500 people

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

Started

Mar 2017

Expected to finish

Jul 2028

An estimate. End dates often move.

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 with heart failure with preserved (HFpEF) or mid-range ejection fraction (HFmrEF) with elevated left atrial pressures, who remain symptomatic despite standard Guideline Directed Medical Therapy (GDMT), in accordance with CE-mark approved labeling.

Ages

40 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.

This is a post market registry so no criteria requirements (only recommendations).

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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

  • Bürgelspital Solothurn

    Solothurn, Switzerland

  • Elisabeth-Krankenhaus Essen

    Essen, Germany

  • Evangelisches Krankenhaus Paul Gerhardt Stift - Unfallstation

    Wittenberg, Germany

  • Heinrich Braun Klinikum

    Zwickaü, Germany

  • Helios Kliniken Schwerin

    Schwerin, 19049, Germany

  • Herz- und Diabeteszentrum Nordrhein-Westfalen Klinik für Kardiologie

    Bad Oeynhausen, Germany

  • Herz-Kreislauf-Zentrum Rotenburg

    Rotenburg (Wümme), Germany

  • Herzzentrum Dresden GmbH

    Dresden, Germany

  • Herzzentrum der Kerckhoff-Klinik

    Bad Nauheim, Germany

  • Herzzentrum der Universität zu Köln

    Cologne, Germany

  • Klinik für Innere Medizin III mit den Schwerpunkten Kardiologie, Angiologie und internistische

    Kiel, Germany

  • Klinikum Chemnitz gGmbH

    Chemnitz, Germany

  • Klinikum Karlsburg

    Karlsburg, Germany

  • Klinikum Lippe GmbH

    Detmold, Germany

  • Klinikum Sankt Georg

    Leipzig, Germany

  • Klinikum am Plattenwald Bad Friedrichshall

    Heilbronn, Germany

  • Niels-Stensen-Kliniken - Marienhospital

    Osnabrück, Germany

  • Segeberger Kliniken GmbH

    Bad Segeberg, Germany

  • St Vincenz-Kranenhaus

    Paderborn, Germany

  • Unfallkrankenhaus Berlin

    Berlin, Germany

  • Universitäts Klinikum Halle

    Halle, Germany

  • Universitätsklinik Ulm-Keßler

    Ülm, Germany

  • Universitätsklinikum Düsseldorf Klinik für Kardiologie, Pneumologie u. Angiologie

    Düsseldorf, Germany

  • Universitätsklinikum Gießen

    Giessen, Germany

  • Universitätsklinikum Göttingen

    Göttingen, Germany

  • Universitätsklinikum Munster

    Münster, Germany

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, Germany

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