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

Prior treatment

• Severe cardiovascular event (e.g. myocardial infarction, open heart surgery, stroke, CRT implantation) in the 2 months prior to admission
• Continuous or intermittent chronic inotropic therapy.

Other illness

• 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)
• Active infection.
• History of recurrent (\>1 episode) pulmonary embolism and/or deep vein throm-bosis.
• Severe, unrepaired congenital heart defect that would prevent implantation of the sensor.
• Presence of a mechanical right heart valve.
• Mental disorder that presumably (in the opinion of the study physician) has a negative impact on patient compliance or consent.
• Failure of the coordinating physician to approve if the patient is enrolled in an HF disease management program or comparable case management program.

Lab values

• Estimated glomerular filtration rate (eGFR) \<25 ml/min

Age

• Women of childbearing age with a positive pregnancy test at the time of inclusion

Other

• Enrolment in another study with an active treatment arm.
• Life expectancy (according to the study physician's assessment) \<12 months.
• Severe valve vitium with planned intervention in the next 3 months
• For the intervention group: Preliminary investigations have shown that the diameter of the pulmonary artery branch intended for implantation is \<7 mm
• The patient has private health insurance

• Written consent received from the patient or a legal representative after the in-formation has been provided.
• ≥ 18 years of age.
• Predominant symptoms in NYHA Stage III in the 30-day period prior to consent to the study.
• Objectified HF diagnosis for more than three months.
• Hospitalisation within 12 months prior to inclusion due to deterioration of HF symptoms.
• Able to tolerate dual antiplatelet therapy or anticoagulation therapy for one month after sensor implantation
• 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.
• 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.
• Chest circumference (measured at axillary level) of less than 165 cm if BMI \>35 kg/m2.
• 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).
• Appropriate domestic situation, defined as being accessible by telephone (via fixed or mobile network) .