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.
Study Type
OBSERVATIONAL
Enrollment
500
Implantation of the IASD device using trans-septal puncture and the IASD system
Herzzentrum der Kerckhoff-Klinik
Bad Nauheim, Germany
Serious Adverse Events
Device and or procedure related serious adverse cardiac events
Time frame: 30 days
New York Heart Classification
Improvement in NYHA Classification
Time frame: 12 months
Quality of Life Improvement (KCCQ score)
Improvement in KCCQ score
Time frame: 12 months
Quality of Life Improvement (EQ5D)
Improvement in EQ5D score
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 17 more locations