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REDUCE LAP-HF III Corvia Protocol 1701
Sponsor: Corvia Medical
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 for patients with heart failure in a "real world" practice setting.
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
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
OBSERVATIONAL
Enrollment
500
Start Date
2017-07-12
Completion Date
2028-07-31
Last Updated
2024-02-08
Healthy Volunteers
No
Conditions
Interventions
IASD Implant
Implantation of the IASD device using trans-septal puncture and the IASD system
Locations (27)
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
Herzzentrum der Universität zu Köln
Cologne, 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
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 (Wümme), Germany
Helios Kliniken Schwerin
Schwerin, Germany
Universitätsklinik Ulm-Keßler
Ülm, Germany
Evangelisches Krankenhaus Paul Gerhardt Stift - Unfallstation
Wittenberg, Germany
Heinrich Braun Klinikum
Zwickaü, Germany
Bürgelspital Solothurn
Solothurn, Switzerland