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

Inclusion Criteria:

1. Written consent received from the patient or a legal representative after thein-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 thestudy.

4. Objectified HF diagnosis for more than three months.

5. Hospitalisation within 12 months prior to inclusion due to deterioration of HFsymptoms.

6. Able to tolerate dual antiplatelet therapy or anticoagulation therapy for one monthafter sensor implantation

7. Patients with reduced left ventricular ejection fraction (LVEF) ≤40% (diagnosedwithin 6 months prior to inclusion) must be treated with guideline-compliant HFpharmacotherapy; if one class of guideline-compliant medication is not tolerated,appropriate documentation must be supplied; patients must receive and tolerate atleast one class of guideline-compliant medication; if no guideline-compliantmedication is tolerated at all, the patient may not participate in the study.

8. In patients with preserved LVEF (>40%; diagnosed within 6 months prior toinclu-sion) comorbidities must be treated in accordance with guideline-compliantmedi-cation.

9. Chest circumference (measured at axillary level) of less than 165 cm if BMI >35kg/m2.

10. Willing and mentally and physically able to meet the requirements for follow-up andlong-term basic care (this includes the long-term willingness of the patient, and oftheir relatives where relevant, to participate in PA pressure-based monitor-ing).

11. Appropriate domestic situation, defined as being accessible by telephone (via fixedor mobile network) .

12. For the intervention group: Implantation is only performed if the diameter of thepulmonary artery branch intended for implantation is ≥7 mm (assessment will be madeduring the right heart catheterization)

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 takenplace or are planned in the next 12 months (e.g. implantation of a left ven-tricularassist 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 thesensor.

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 anegative impact on patient compliance or consent.

13. Failure of the coordinating physician to approve if the patient is enrolled in an HFdisease management program or comparable case management program.

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