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Pulmonary Artery Sensor System Pressure Monitoring to Improve Heart Failure (HF) Outcomes
Sponsor: IHF GmbH - Institut für Herzinfarktforschung
Summary
Randomized, parallel group controlled study examines the effect of supporting the Heart failure supply through pulmonary arterial (PA) pressure measurement with the CardioMEMS™ HF system to hard endpoints, safety and quality of life. The target population consists of heart failure (HF) patients who have been predominantly in New York Heart Association (NYHA) Stage III for the past 30 days and at least once in the past 12 months for HF were admitted to hospital. All patients receive basic care, which is based on structured telephone contact (between the care center, patient and family doctor) to optimize guideline compliant therapy. In the intervention group a PA pressure sensor is (CardioMEMS™-HF Sensor) implanted. These patients are structured by specially trained non-medical personnel aftercare with additional inclusion of the PA pressure values: adjusted to the basis of the information collected in PA monitoring the therapy is optimized. The follow-up period until the primary endpoint is 12 months. In addition, data on longtime-mortality is being collected towards the end of the study for all study participants.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
554
Start Date
2020-10-02
Completion Date
2026-12-09
Last Updated
2026-04-07
Healthy Volunteers
No
Conditions
Interventions
CardioMEMSTM HF sensor - pulmonary artery pressure measurement
CardioMEMSTM HF sensor implantation to meassure pulmonary artery pressure. Evaluation of the pressure curves by telemetric transmission and coordination of necessary adjustments of the therapy.
Locations (36)
SLK-Kliniken GmbH - Klinikum am Plattenwald
Bad Friedrichshall, Germany
Kerckhoff-Klinik Forschungs GmbH
Bad Nauheim, Germany
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, Germany
BG Unfallkrankenhaus Berlin
Berlin, Germany
Charité Universitätsmedizin (Campus Mitte, Campus Virchow, Campus Benjamin Franklin)
Berlin, Germany
DHZC, Campus Virchow
Berlin, Germany
Praxis am Spreebogen
Berlin, Germany
Sana Klinikum Lichtenberg
Berlin, Germany
Klinikum Bielefeld
Bielefeld, Germany
Universitätsklinikum Bonn
Bonn, Germany
Klinikum Coburg
Coburg, Germany
St Johannes Hospital Dortmund
Dortmund, Germany
Praxisklinik Herz und Gefäße
Dresden, Germany
Universitäts-Herzzentrum Dresden
Dresden, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
St. Georg Klinikum
Eisenach, Germany
Helios Klinikum Erfurt
Erfurt, Germany
St. Elisabeth Krankenhaus, Contilia Herz- und Gefäßzentrum
Essen, Germany
Universitätsklinikum Essen
Essen, Germany
Universitätsklinikum Frankfurt
Frankfurt, Germany
Klinikum Fürth
Fürth, Germany
Universitätsklinikum Gießen
Giessen, Germany
Universitäres Herz- und Gefäßzentrum Hamburg
Hamburg, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Universitätsklinikum Jena
Jena, Germany
Westpfalz Klinikum
Kaiserslautern, Germany
Klinikum Karlsburg
Karlsburg, Germany
Leipzig Heart Institute GmbH
Leipzig, Germany
Cardio Centrum Ludwigsburg-Bietigheim
Ludwigsburg, Germany
Universitätsklinikum Magdeburg
Magdeburg, Germany
Klinikum Oldenburg
Oldenburg, Germany
Cardio Consil Rostock
Rostock, Germany
Krankenhaus der Barmherzigen Brüder
Trier, Germany
Schwarzwald-Baar Klinikum
Villingen-Schwenningen, Germany
Rems-Murr Klinikum
Winnenden, Germany
Deutsches Zentrum für Herzinsuffizienz (DZHI)
Würzburg, Germany