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Heart FailureREDUCELAPHFIIINCT03191656

REDUCE LAP-HF III Corvia Protocol 1701

An observational study of Heart Failure, run by Corvia Medical at 27 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a post market trial to be conducted at sites in Germany. The device has CE approval in the EU. The purpose of this observational registry is to collect post market data in consecutive patients treated with the IASD System II, to further evaluate efficacy, safety and quality of life outcomes as a new treatment… Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Heart Failure
What is being tested?
IASD Implant
Type of treatment
Medical device
How many people
500 participants
Where
27 sitesin 2 countries
Study dates
12 Mar 2017to 31 Jul 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

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

Trial locations and contacts

27 sites in 2 countries.

27 sites in 2 countries

Germany26 sites

  • Herzzentrum der Kerckhoff-Klinik

    Bad Nauheim

  • Herz- und Diabeteszentrum Nordrhein-Westfalen Klinik für Kardiologie

    Bad Oeynhausen

  • Segeberger Kliniken GmbH

    Bad Segeberg

  • Unfallkrankenhaus Berlin

    Berlin

  • Klinikum Chemnitz gGmbH

    Chemnitz

  • Herzzentrum der Universität zu Köln

    Cologne

  • Klinikum Lippe GmbH

    Detmold

  • Herzzentrum Dresden GmbH

    Dresden

  • Universitätsklinikum Düsseldorf Klinik für Kardiologie, Pneumologie u. Angiologie

    Düsseldorf

  • Elisabeth-Krankenhaus Essen

    Essen

  • Universitätsklinikum Gießen

    Giessen

  • Universitätsklinikum Göttingen

    Göttingen

  • Universitäts Klinikum Halle

    Halle

  • Klinikum am Plattenwald Bad Friedrichshall

    Heilbronn

  • Klinikum Karlsburg

    Karlsburg

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

    Kiel

  • Klinikum Sankt Georg

    Leipzig

  • Universitätsklinikum Schleswig-Holstein

    Lübeck

  • Universitätsklinikum Munster

    Münster

  • Niels-Stensen-Kliniken - Marienhospital

    Osnabrück

  • St Vincenz-Kranenhaus

    Paderborn

  • Herz-Kreislauf-Zentrum Rotenburg

    Rotenburg (Wümme)

  • Helios Kliniken Schwerin

    Schwerin, 19049

  • Universitätsklinik Ulm-Keßler

    Ülm

  • Evangelisches Krankenhaus Paul Gerhardt Stift - Unfallstation

    Wittenberg

  • Heinrich Braun Klinikum

    Zwickaü

Other trials in Germany

Switzerland1 site

  • Bürgelspital Solothurn

    Solothurn

Other trials in Switzerland

About this study

Official title: A Post-Market Clinical Follow-up Study to Evaluate the Corvia Medical, Inc. InterAtrial Shunt Device - IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients With Heart Failure

This is a post market trial to be conducted at sites in Germany. The device has CE approval in the EU. The purpose of this observational registry is to collect post market data in consecutive patients treated with the IASD System II, to further evaluate efficacy, safety and quality of life outcomes as a new treatment for patients with heart failure in a "real world" practice setting.

Conditions
Heart Failure
Being tested
IASD Implant
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IASD ImplantDevice

    Implantation of the IASD device using trans-septal puncture and the IASD system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serious Adverse Events

    Device and or procedure related serious adverse cardiac events

    Measured: 30 days

  2. New York Heart Classification

    Improvement in NYHA Classification

    Measured: 12 months

  3. Quality of Life Improvement (KCCQ score)

    Improvement in KCCQ score

    Measured: 12 months

  4. Quality of Life Improvement (EQ5D)

    Improvement in EQ5D score

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2017
  2. Study start12 Mar 2017
  3. Primary completion31 Jul 2026 (estimated)
  4. Study completion31 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03191656
Sponsor's protocol ID
1701
Acronym
REDUCELAPHFIII
Status last verified
May 2026
First submitted
12 Jun 2017
Last updated
12 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by Corvia Medical at 27 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serious Adverse Events (time frame: 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03191656.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.

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REDUCE LAP-HF III Corvia Protocol 1701 (NCT03191656) | AzTrials