PROACTIVE-HF IDE Trial Heart Failure NYHA Class III
N/A
Active, not recruiting
NCT04089059
| Condition | Heart Failure NYHA Class III |
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| Phase | N/A |
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| Sponsor | Endotronix, Inc. |
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| Status | Active, not recruiting |
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| Enrollment | 738 participants |
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| Interventions | Cordella™ Pulmonary Artery Sensor System |
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| Start date | Jan 10, 2020 |
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| Completion date | Apr, 2028 |
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| Results posted | Mar 3, 2025 |
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Summary
This is a prospective, open- label, single arm, multicenter clinical trial to evaluate the safety and effectiveness of the Cordella PA Sensor System in NYHA Class III Heart Failure Patients compared to a Performance Goal (PG).
Efficacy 6 Month Incidence of HF Related Hospitalizations (HFH) or All-cause Mortality
6 months · Events Per Patient Per 6 Months
| Modified Intent-to-Treat (mITT) | 0.1549 Events Per Patient Per 6 Months |
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| Former Control Arm | 0.2787 Events Per Patient Per 6 Months |
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Safety: Freedom From Device/System Related Complication
6 months · Proportion of patients without a DSRC
| Intent-to-Treat (ITT) | 0.992 Proportion of patients without a DSRC |
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| Former Control Arm | 0.986 Proportion of patients without a DSRC |
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Safety: Freedom From Pressure Sensor Failure
6 months · Proportion of patients without a PSF
| Intent-to-Treat (ITT) | 0.998 Proportion of patients without a PSF |
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| Former Control Arm | 1.000 Proportion of patients without a PSF |
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Open in BENITIONS
View on ClinicalTrials.gov
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