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

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.

NCT Number	NCT04398654
Lead Sponsor	IHF GmbH - Institut für Herzinfarktforschung
Conditions	Heart Failure
Enrollment	554 participants
Start Date	2020-10-02
Primary Completion	2025-11-25 (estimated)
Study Completion	2026-12-09 (estimated)
Updated on ClinicalTrials.gov	2026-04-07