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
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.
Herzzentrum der Kerckhoff-Klinik
Bad Nauheim, Germany
Herz- und Diabeteszentrum Nordrhein-Westfalen Klinik für Kardiologie
Bad Oeynhausen, Germany
RECRUITINGSegeberger Kliniken GmbH
Bad Segeberg, Germany
RECRUITINGUnfallkrankenhaus Berlin
Berlin, Germany
RECRUITINGKlinikum Chemnitz gGmbH
Chemnitz, Germany
RECRUITINGHerzzentrum der Universität zu Köln
Cologne, Germany
RECRUITINGKlinikum Lippe GmbH
Detmold, Germany
TERMINATEDHerzzentrum Dresden GmbH
Dresden, Germany
RECRUITINGUniversitätsklinikum Düsseldorf Klinik für Kardiologie, Pneumologie u. Angiologie
Düsseldorf, Germany
RECRUITINGElisabeth-Krankenhaus Essen
Essen, Germany
TERMINATED...and 17 more locations