RecruitingNCT03191656

REDUCE LAP-HF III Corvia Protocol 1701

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

Sponsor

Corvia Medical

Enrollment

500 participants

Start Date

Jul 12, 2017

Study Type

OBSERVATIONAL

Conditions

Heart Failure

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.

Eligibility

Min Age: 40 Years

Inclusion Criteria1

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

Interventions

DEVICEIASD 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

View Full Details on ClinicalTrials.gov

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