REDUCE LAP-HF III Corvia Protocol 1701

Recruiting

• Conditions: Heart Failure

• Registration Number: NCT03191656
• Lead Sponsor: Corvia Medical

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-12
• Study First Submitted QC: 2017-06-16
• Study First Posted: 2017-06-19
• Study Start: 2017-07-12
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-08
• Primary Completion: 2026-07-31
• Study Completion: 2028-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serious Adverse Events	30 days	Device and or procedure related serious adverse cardiac events
Quality of Life Improvement (EQ5D)	12 months	Improvement in EQ5D score
Quality of Life Improvement (KCCQ score)	12 months	Improvement in KCCQ score
New York Heart Classification	12 months	Improvement in NYHA Classification

Trial Locations

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

Klinikum Lippe GmbH; 🇩🇪 Detmold, Germany

Unfallkrankenhaus Berlin; 🇩🇪 Berlin, Germany

Klinikum Chemnitz gGmbH; 🇩🇪 Chemnitz, Germany

Herzzentrum Dresden GmbH; 🇩🇪 Dresden, Germany

Universitätsklinikum Düsseldorf Klinik für Kardiologie, Pneumologie u. Angiologie; 🇩🇪 Düsseldorf, Germany

Elisabeth-Krankenhaus Essen; 🇩🇪 Essen, Germany

Universitätsklinikum Göttingen; 🇩🇪 Göttingen, Germany

Universitätsklinikum Gießen; 🇩🇪 Giessen, Germany

Herzzentrum der Universität zu Köln; 🇩🇪 Köln, Germany

Universitäts Klinikum Halle; 🇩🇪 Halle, Germany

Klinik für Innere Medizin III mit den Schwerpunkten Kardiologie, Angiologie und internistische; 🇩🇪 Kiel, Germany

Klinikum Sankt Georg; 🇩🇪 Leipzig, Germany

Klinikum am Plattenwald Bad Friedrichshall; 🇩🇪 Heilbronn, Germany

Universitätsklinikum Schleswig-Holstein; 🇩🇪 Lübeck, Germany

Klinikum Karlsburg; 🇩🇪 Karlsburg, Germany

Niels-Stensen-Kliniken - Marienhospital; 🇩🇪 Osnabrück, Germany

St Vincenz-Kranenhaus; 🇩🇪 Paderborn, Germany

Universitätsklinikum Munster; 🇩🇪 Münster, Germany

Herz-Kreislauf-Zentrum Rotenburg; 🇩🇪 Rotenburg, Germany

Evangelisches Krankenhaus Paul Gerhardt Stift - Unfallstation; 🇩🇪 Wittenberg, Germany

Universitätsklinik Ulm-Keßler; 🇩🇪 Ülm, Germany

Helios Kliniken Schwerin; 🇩🇪 Schwerin, Germany

Heinrich Braun Klinikum; 🇩🇪 Zwickaü, Germany

Bürgelspital Solothurn; 🇨🇭 Solothurn, Switzerland