NCT04398654

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 554 (estimated)
• Sponsor: IHF GmbH - Institut für Herzinfarktforschung · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	CardioMEMSTM HF sensor - pulmonary artery pressure measurement	CardioMEMSTM HF sensor implantation to meassure pulmonary artery pressure. Evaluation of the pressure curves by telemetric transmission and coordination of necessary adjustments of the therapy.

Timeline

• Start date: 2020-10-02
• Primary completion: 2025-11-25
• Completion: 2026-12-09
• First posted: 2020-05-21
• Last updated: 2026-04-07

Locations

36 sites across 1 country: Germany