A Prospective, Multi-Center, Open Label, Single Arm Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in NYHA Class III Heart Failure Patients (PROACTIVE- HF Trial)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Failure NYHA Class III
- Sponsor
- Endotronix, Inc.
- Enrollment
- 738
- Locations
- 73
- Primary Endpoint
- Efficacy 6 Month Incidence of HF Related Hospitalizations (HFH) or All-cause Mortality
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
Brief 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).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Efficacy 6 Month Incidence of HF Related Hospitalizations (HFH) or All-cause Mortality
Time Frame: 6 months
The primary efficacy endpoint was the 6-month incidence of HF related hospitalizations or all-cause mortality in the modified Intent-to-Treat (mITT) population. As per the approved protocol/CIP, for study success the upper confidence bound of the observed event rate in the mITT population was required to be less than the performance goal (PG) of 0.43 events per patient 6-month, or equivalently, the corresponding p-value from the hypothesis test of 6-month incidence rate compared to PG was less than 0.025. Furthermore, the observed incidence rate was required to be less than 0.37. The 6-month incidence rate was derived using a Poisson regression with the number of events as the dependent variable and the exposure time as an offset term. In these analyses, a subject's exposure time was defined as the time to death, early study discontinuation, or 6 months (whichever occurred first).
Safety: Freedom From Device/System Related Complication
Time Frame: 6 months
A device/system related complication (DSRC) is defined as an AE that is, or is possibly, related to the device/system (Cordella PA Sensor or electronic components) and is either treated invasively (other than intramuscular medication or diagnostic RHC) or results in subject´s death or explant of the device. The first primary safety endpoint describes freedom from a DSRC through 6 months and was tested against the null rate of 90%.
Safety: Freedom From Pressure Sensor Failure
Time Frame: 6 months
A pressure sensor failure (PSF) occurs when the sensor malfunctions to the point that no readings can be obtained from the sensor after all attempts are exhausted including troubleshooting the system to rule out any problems with the electronic components. The second primary safety endpoint describes freedom from Pressure Sensor Failure through 6 months, it was tested against the null rate of 95%.
Secondary Outcomes
- HF Hospitalizations(6 Months prior to implant and 6 months post implant)
- HF Hospitalizations or Emergency Department/Hospital Outpatient IV Diuretic Visits.(6 months)
- Mortality(6 Months)
- IV Diuretic Visits(6 Months)
- Pulmonary Artery Pressure (PAP)(6 months)
- Device Success(6 Months)
- Kansas City Cardiomyopathy Questionnaire (KCCQ)(6 Months)
- NYHA(6 Months)
- 6-Minute Walk Test(6 Months)
- Number and Percent of Patients With Serious Adverse Events(6 Months)
- Incidence of HF Hospitalizations or All-cause Mortality(12 months)
- N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)(6 months)
- Days Alive and Out of Hospital (DAOH)(6 Months)
- Number of Heart Failure Related Medication Changes(6 Months)
- Number of HF Hospitalization or All-cause Mortality(12 months)
- Number of HF Hospitalization, Emergency Department/Hospital Outpatient IV Diuretic Visits, All-cause Mortality(6 months)
- Number of HF Hospitalization, Emergency Department/Hospital Outpatient IV Diuretic Visits(6 months)
- Implant Procedure and Procedure Related Adverse Events and Serious Adverse Events(6 months)