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ACTIVE NOT RECRUITING
NCT04398654
NA

Pulmonary Artery Sensor System Pressure Monitoring to Improve Heart Failure (HF) Outcomes

Sponsor: IHF GmbH - Institut für Herzinfarktforschung

View on ClinicalTrials.gov

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

DEVICE

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