Research article
Seated Pulmonary Artery Pressure Monitoring in Patients With Heart Failure
- Single-arm clinical trial
- open-label
- multicentre
- 75 centres in the US and Europe
- changed from randomised to single-arm
- performance goal
Patients implanted between February 7, 2020, and March 31, 2023
Authors' conclusion
Remote management of seated mPAP is safe and results in a low rate of HF hospitalizations and mortality.
Study context
- Population
- Chronic heart failure (HF), NYHA class III irrespective of EF, with recent HF hospitalization and/or elevated natriuretic peptidesmodified ITT cohort
- Participants
- 456 participants
- Comparison
- Seated mean pulmonary artery pressure (mPAP)-guided management vs performance goal of 0.43 events/patient
- Cordella Pulmonary Artery sensorn = 456
- Outcome
- HF hospitalization or all-cause mortality rate, compared with a performance goal of 0.43 events/patient
- Follow-up
- 6 months
Main finding
As reported in the abstract
HF hospitalization or all-cause mortality rate (events/patient)
6-month event rate
0.15 (95% CI: 0.12-0.20)
Significantly lower than performance goal (0.15 vs 0.43)
P < 0.0001
Safety
Freedom from device- or system-related complications; freedom from sensor failure · through 6 months
- Freedom from device- or system-related complications
- 99.2%
- Freedom from sensor failure
- 99.8%
Original publication
Seated Pulmonary Artery Pressure Monitoring in Patients With Heart Failure. JACC Heart Fail. Published 14 August 2024. doi:10.1016/j.jchf.2024.05.017
Summarised from the published abstract; every number is checked against it