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. 2022 Mar 4;111(11):1245–1255. doi: 10.1007/s00392-022-01987-3

Table 1.

Inclusion criteria

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)