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Clinical Trials in Germany / NCT04398654
Active, not recruiting Not applicable

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

NCT04398654 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2020-10-02
Last updated
2026-04-07

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

CardioMEMSTM HF sensor - pulmonary artery pressure measurement

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Written consent received from the patient or a legal representative after the in-formation has been provided. 2. ≥ 18 years of age. 3. Predominant symptoms in NYHA Stage III in the 30-day period prior to consent to the study. 4. Objectified HF diagnosis for more than three months. 5. Hospitalisation within 12 months prior to inclusion due to deterioration of HF symptoms. 6. Able to tolerate dual antiplatelet therapy or anticoagulation therapy for one month after sensor implantation 7. Patients with reduced left ventricular ejection fraction (LVEF) ≤40% (diagnosed within 6 months prior to inclusion) must be treated with guideline-compliant HF pharmacotherapy; if one class of guideline-compliant medication is not tolerated, appropriate documentation must be supplied; patients must receive and tolerate at least one class of guideline-compliant medication; if no guideline-compliant medication is tolerated at all, the patient may not participate in the study. 8. In patients with preserved LVEF (\>40%; diagnosed within 6 months prior to inclu-sion) comorbidities must be treated in accordance with guideline-compliant medi-cation. 9. Chest circumference (measured at axillary level) of less than 165 cm if BMI \>35 kg/m2. 10. Willing and mentally and physically able to meet the requirements for follow-up and long-term basic care (this includes the long-term willingness of the patient, and of their relatives where relevant, to participate in PA pressure-based monitor-ing). 11. Appropriate domestic situation, defined as being accessible by telephone (via fixed or mobile network) . Exclusion criteria: 1. Enrolment in another study with an active treatment arm. 2. Severe cardiovascular event (e.g. myocardial infarction, open heart surgery, stroke, CRT implantation) in the 2 months prior to admission 3. Therapy-refractory heart failure in ACC/AHA stage D or new therapies that have taken place or are planned in the next 12 months (e.g. implantation of a left ven-tricular assist system / transplantation) 4. Active infection. 5. History of recurrent (\>1 episode) pulmonary embolism and/or deep vein throm-bosis. 6. Continuous or intermittent chronic inotropic therapy. 7. Estimated glomerular filtration rate (eGFR) \<25 ml/min 8. Life expectancy (according to the study physician's assessment) \<12 months. 9. Severe, unrepaired congenital heart defect that would prevent implantation of the sensor. 10. Severe valve vitium with planned intervention in the next 3 months 11. Presence of a mechanical right heart valve. 12. Mental disorder that presumably (in the opinion of the study physician) has a negative impact on patient compliance or consent. 13. Failure of the coordinating physician to approve if the patient is enrolled in an HF disease management program or comparable case management program. 14. Women of childbearing age with a positive pregnancy test at the time of inclusion 15. For the intervention group: Preliminary investigations have shown that the diameter of the pulmonary artery branch intended for implantation is \<7 mm 16. The patient has private health insurance

Primary outcome measure(s)

Trial sites (36)

FacilityCityRegionStatus
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

More IHF GmbH - Institut für Herzinfarktforschung trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04398654 on ClinicalTrials.gov ↗ ← All trials in Germany