Heart Failure Clinical Trial
— REDUCELAPHFIIIOfficial 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
| NCT number | NCT03191656 |
| Other study ID # | 1701 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 12, 2017 |
| Est. completion date | July 31, 2028 |
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.
| Status | Recruiting |
| Enrollment | 500 |
| Est. completion date | July 31, 2028 |
| Est. primary completion date | July 31, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years and older |
| Eligibility | This is a post market registry so no criteria requirements (only recommendations). |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Herzzentrum der Kerckhoff-Klinik | Bad Nauheim | |
| Germany | Herz- und Diabeteszentrum Nordrhein-Westfalen Klinik für Kardiologie | Bad Oeynhausen | |
| Germany | Segeberger Kliniken GmbH | Bad Segeberg | |
| Germany | Unfallkrankenhaus Berlin | Berlin | |
| Germany | Klinikum Chemnitz gGmbH | Chemnitz | |
| Germany | Klinikum Lippe GmbH | Detmold | |
| Germany | Herzzentrum Dresden GmbH | Dresden | |
| Germany | Universitätsklinikum Düsseldorf Klinik für Kardiologie, Pneumologie u. Angiologie | Düsseldorf | |
| Germany | Elisabeth-Krankenhaus Essen | Essen | |
| Germany | Universitätsklinikum Gießen | Giessen | |
| Germany | Universitätsklinikum Göttingen | Göttingen | |
| Germany | Universitäts Klinikum Halle | Halle | |
| Germany | Klinikum am Plattenwald Bad Friedrichshall | Heilbronn | |
| Germany | Klinikum Karlsburg | Karlsburg | |
| Germany | Klinik für Innere Medizin III mit den Schwerpunkten Kardiologie, Angiologie und internistische | Kiel | |
| Germany | Herzzentrum der Universität zu Köln | Köln | |
| Germany | Klinikum Sankt Georg | Leipzig | |
| Germany | Universitätsklinikum Schleswig-Holstein | Lübeck | |
| Germany | Universitätsklinikum Munster | Münster | |
| Germany | Niels-Stensen-Kliniken - Marienhospital | Osnabrück | |
| Germany | St Vincenz-Kranenhaus | Paderborn | |
| Germany | Herz-Kreislauf-Zentrum Rotenburg | Rotenburg | |
| Germany | Helios Kliniken Schwerin | Schwerin | |
| Germany | Universitätsklinik Ulm-Keßler | Ülm | |
| Germany | Evangelisches Krankenhaus Paul Gerhardt Stift - Unfallstation | Wittenberg | |
| Germany | Heinrich Braun Klinikum | Zwickaü | |
| Switzerland | Bürgelspital Solothurn | Solothurn |
| Lead Sponsor | Collaborator |
|---|---|
| Corvia Medical |
Germany, Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Serious Adverse Events | Device and or procedure related serious adverse cardiac events | 30 days | |
| Primary | New York Heart Classification | Improvement in NYHA Classification | 12 months | |
| Primary | Quality of Life Improvement (KCCQ score) | Improvement in KCCQ score | 12 months | |
| Primary | Quality of Life Improvement (EQ5D) | Improvement in EQ5D score | 12 months |
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