1 |
Written informed consent received from the patient or a legal representative after the information 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 3 months |
5 |
Hospitalization within 12 months prior to inclusion due to deterioration of HF symptoms |
6 |
Able to tolerate dual antiplatelet therapy or anticoagulation therapy for 1 month after sensor implantation |
7 |
Patients with reduced left ventricular ejection fraction (LVEF) ≤ 40% (assessed 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%; assessed within 6 months prior to inclusion), comorbidities must be treated in accordance with guideline-compliant medication |
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 monitoring) |
11 |
Appropriate domestic situation, defined as being accessible by telephone (via fixed or mobile network)a
|
12 |
For the intervention group: implantation is only performed if the diameter of the pulmonary artery branch intended for implantation is ≥ 7 mm (assessment will be made during the right heart catheterization) |