Heart failure & cardiomyopathies
Twelve-Month Follow-Up Results from the SIRONA 2 Clinical Trial
Authors' conclusion
Long-term follow-up of the SIRONA 2 trial supports the safety and accuracy of the Cordella PA Sensor System in enabling comprehensive HF management in NYHA class III HF patients.
Study context
- Population
- New York Heart Association (NYHA) class III heart failure (HF) with a prior HF hospitalization and/or increase of NT-proBNP within 12 months of enrolment
- Participants
- 70 participants
- Primary endpoint
- Prespecified secondary endpoints: safety and accuracy of the PA sensor (vs RHC)
- Follow-up
- 12 months
Methodological detailsprospective, multicentre, open-label
- Prospective
- Multicentre
- Open-label
Primary result
As reported in the abstract
Average difference for mean PAP, sensor vs right heart catheterization (RHC) (mean ± SD)
2.9 ± 7.3 mmHg
Freedom from device/system-related complications
98.4%
Pressure sensor failures
0
Secondary outcomes
HF hospitalizations and mortality · 12 months
- Event rate per patient year
- 0.33
NYHA symptoms · 12 months
- Significantly improved
- P < 0.0001
Functional capacity (6 min walk test) · 12 months
- Significantly improved
- P = 0.02
Adherence to daily transmissions of PAP and vital signs · 12 months
- Adherence
- 95%
Safety
Device/system-related complications · 12 months
- Freedom from device/system-related complications
- 98.4%
- Pressure sensor failures
- 0
Original publication
Composed by AI from the published abstract and checked against it. How Briefs are made →