Clinical trial NCT03191656: REDUCE LAP-HF III Corvia Protocol 1701
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Lead sponsor: Corvia Medical
Sponsor class: INDUSTRY
First posted: 2017-06-19
Enrollment: 500
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with heart failure with preserved (HFpEF) or mid-range ejection fraction (HFmrEF) with elevated left atrial pressures, who remain symptomatic despite standard Guideline Directed Medical Therapy (GDMT), in accordance with CE-mark approved labeling.

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.


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

Primary outcomes:
measure: Serious Adverse Events
timeFrame: 30 days
measure: New York Heart Classification
timeFrame: 12 months
measure: Quality of Life Improvement (KCCQ score)
timeFrame: 12 months
measure: Quality of Life Improvement (EQ5D)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Nauheim
country: Germany
facility: Herzzentrum der Kerckhoff-Klinik
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum Nordrhein-Westfalen Klinik für Kardiologie
city: Bad Segeberg
country: Germany
facility: Segeberger Kliniken GmbH
city: Berlin
country: Germany
facility: Unfallkrankenhaus Berlin
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
city: Detmold
country: Germany
facility: Klinikum Lippe GmbH
city: Dresden
country: Germany
facility: Herzzentrum Dresden GmbH
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf Klinik für Kardiologie, Pneumologie u. Angiologie
city: Essen
country: Germany
facility: Elisabeth-Krankenhaus Essen
city: Giessen
country: Germany
facility: Universitätsklinikum Gießen
city: Göttingen
country: Germany
facility: Universitätsklinikum Göttingen
city: Halle
country: Germany
facility: Universitäts Klinikum Halle
city: Heilbronn
country: Germany
facility: Klinikum am Plattenwald Bad Friedrichshall
city: Karlsburg
country: Germany
facility: Klinikum Karlsburg
city: Kiel
country: Germany
facility: Klinik für Innere Medizin III mit den Schwerpunkten Kardiologie, Angiologie und internistische
city: Köln
country: Germany
facility: Herzzentrum der Universität zu Köln
city: Leipzig
country: Germany
facility: Klinikum Sankt Georg
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Münster
country: Germany
facility: Universitätsklinikum Munster
city: Osnabrück
country: Germany
facility: Niels-Stensen-Kliniken - Marienhospital
city: Paderborn
country: Germany
facility: St Vincenz-Kranenhaus
city: Rotenburg
country: Germany
facility: Herz-Kreislauf-Zentrum Rotenburg
city: Schwerin
country: Germany
facility: Helios Kliniken Schwerin
city: Wittenberg
country: Germany
facility: Evangelisches Krankenhaus Paul Gerhardt Stift - Unfallstation
city: Zwickaü
country: Germany
facility: Heinrich Braun Klinikum
city: Ülm
country: Germany
facility: Universitätsklinik Ulm-Keßler
city: Solothurn
country: Switzerland
facility: Bürgelspital Solothurn
Study officials:
References: