PROACTIVE-HF IDE Trial Heart Failure NYHA Class III
Condition(s) studied
Investigational drug(s) / intervention(s)
Cordella™ Pulmonary Artery Sensor System: The Cordella PA Sensor System (CorPASS) is intended to measure, record, and transmit pulmonary artery pressure (PAP) data from NYHA Class III heart failure patients at home to clinicians for assessment and patient-centered heart failure management and comprises of seven subsystems that operate together to take daily Pulmonary Artery Pressure (PAP) readings at a patient's home and transmit the results to a care provider for evaluation. 1. Cordella Sensor 2. Cordella Delivery System 3. myCordella Patient Reader 4. Reader Dock 5. Cordella Calibration Equipment (CalEQ) 6. myCordella Hub 7. Cordella Data Analysis Platform (CDAP)
Study 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).
Eligibility
Primary outcome measure(s)
- Efficacy 6 Month Incidence of HF Related Hospitalizations (HFH) or All-cause Mortality — 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 — 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 — 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%.
Trial sites (74)
| Facility | City | Region | Status |
|---|---|---|---|
| Ascension St Vincent's | Birmingham | Alabama | |
| Huntsville Hospital | Huntsville | Alabama | |
| Phoenix Cardiovascular Research Group/Insight | Phoenix | Arizona | |
| Loma Linda University | Loma Linda | California | |
| Eisenhower Medical Center | Rancho Mirage | California | |
| UCSD | San Diego | California | |
| Kaiser San Francisco | San Francisco | California | |
| UCSF Medical Center | San Francisco | California | |
| Kaiser Santa Clara | Santa Clara | California | |
| South Denver Cardiology | Littleton | Colorado | |
| Hartford Hospital | Hartford | Connecticut | |
| Baptist Health South Florida | Miami | Florida | |
| Ascension Sacred Heart | Pensacola | Florida | |
| USF Health | Tampa | Florida | |
| Cleveland Clinic | Weston | Florida | |
| Piedmont Athens | Athens | Georgia | |
| Queens Medical Center | Honolulu | Hawaii | |
| Northwestern | Chicago | Illinois | |
| U of Chicago | Chicago | Illinois | |
| Heart Centers of Illinois | Palos Park | Illinois | |
| OSF Healthcare | Peoria | Illinois | |
| Ascension St Vincent's | Indianapolis | Indiana | |
| University of Iowa Medical Center | Iowa City | Iowa | |
| University of Kansas Medical Center (KUMC) | Kansas City | Kansas | |
| University Of Louisville | Louisville | Kentucky | |
| Ochsner Medical Center | New Orleans | Louisiana | |
| University of Maryland | Baltimore | Maryland | |
| Medstar | Baltimore | Maryland | |
| Tufts Medical Center | Boston | Massachusetts | |
| Beth Israel Deaconess Medical Center (BIDMC) | Boston | Massachusetts | |
| Brigham and Women's Hospital (Mass General Brigham) | Boston | Massachusetts | |
| Henry Ford Hospital | Detroit | Michigan | |
| Minneapolis Heart Institute Foundation | Minneapolis | Minnesota | |
| University of Minnesota | Minneapolis | Minnesota | |
| Centra Care Heart Center | Saint Cloud | Minnesota | |
| St. Lukes/ Mid-American Heart Institute | Kansas City | Missouri | |
| Hackensack University Medical Center | Hackensack | New Jersey | |
| The Valley Hospital | Ridgewood | New Jersey | |
| Mount Sinai | New York | New York | |
| NYU Langone Health | New York | New York |
+ 34 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04089059 on ClinicalTrials.gov ↗ ← All trials in Ireland