PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and 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, with the goal of reducing heart failure hospitalizations. The system 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. Cordella Sensor Cordella Delivery System myCordella Patient Reader Reader Dock Cordella Calibration Equipment (CalEQ) myCordella Tablet Cordella Data Analysis Platform (CDAP)
Study summary
This is a prospective, multi-center, open label, randomized control clinical trial evaluating the safety and efficacy of the Cordella™ Pulmonary Artery Sensor System in NYHA Class II-III Heart Failure Patients (PROACTIVE-HF-2 Trial).
The study contains of 5 arms:
NYHA II Cohort - To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class II HF patients, where patients have daily access to PAP data.
* Treatment Arm (Group 1)
* Active Control Arm (Group 2)
* Crossover Arm (Group 3)
NYHA III Cohort - To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class III HF patients, where patients have daily access to PAP data, including a randomized sub-study to evaluate a clinician-directed patient self-management strategy.
Eligibility
Primary outcome measure(s)
- Efficacy- NYHA II Cohort - A composite of first HF event or death from Cardiovascular Death up to 24 months. — 24 months
A composite endpoint of first HF event or death from CVD up to 24 months. - Efficacy- NYHA III Cohort (Phase I) - a composite of HF events or death from cardiovascular disease at 6 months — 12 months
A composite of HF events or death from cardiovascular disease at 6 months - Safety- Randomized Arm- Freedom from device/system related complication — 24 months
Freedom from device/system related complication at 24 months - Safety- Randomized Arm-Freedom from pressure sensor failure — 24 months
Freedom from pressure sensor failure at 24 months - Safety- Single Arm-Freedom from device/system related complication — 12 months
Freedom from device/system related complication at 12 months - Safety- Single Arm- Freedom from pressure sensor failure — 12 months
Freedom from pressure sensor failure at 12 months - Efficacy- NYHA III Cohort (Phase II) - A test of non-inferiority at 12 months of the percentage of patients at or below trend seated mPAP of 25 mmHg in (i) Clinician-Directed Patient Self-Management vs. (ii) Clinician Management Arm — 12 months
A test of non-inferiority at 12 months of the percentage of patients at or below trend seated mPAP of 25 mmHg in (i) Clinician-Directed Patient Self-Management vs. (ii) Clinician Management Arm
Trial sites (48)
| Facility | City | Region | Status |
|---|---|---|---|
| St. Joseph's Hospital and Medical Center | Phoenix | Arizona | Recruiting |
| USC | Los Angeles | California | Recruiting |
| UCSF Medical Center | San Francisco | California | Recruiting |
| Baptist Health South Florida | Miami | Florida | Recruiting |
| Ascension Sacred Heart | Pensacola | Florida | Recruiting |
| Piedmont | Atlanta | Georgia | Recruiting |
| Advocate Health System | Downers Grove | Illinois | Recruiting |
| Heart Care Centers of Illinois (HCCI) | Palos Park | Illinois | Recruiting |
| Ascension St. Vincent's | Indianapolis | Indiana | Recruiting |
| University of Kansas Medical Center (KUMC) | Kansas City | Kansas | Recruiting |
| MedStar | Baltimore | Maryland | Recruiting |
| Tufts Medical Center | Boston | Massachusetts | Recruiting |
| Boston Medical Center Corporation | Boston | Massachusetts | Not Yet Recruiting |
| Ascension Providence Hospital Cardiology - Heart Cardiology | Howell | Michigan | Recruiting |
| University of Minnesota | Minneapolis | Minnesota | Recruiting |
| Centra Care Heart Center | Saint Cloud | Minnesota | Recruiting |
| St. Lukes/ Mid-American Heart Institute | Kansas City | Missouri | Recruiting |
| Mount Sinai West | New York | New York | Recruiting |
| Mount Sinai | New York | New York | Recruiting |
| Lenox Hill/ Northwell Health | New York | New York | Recruiting |
| Stony Brook University Med Center | Stony Brook | New York | Recruiting |
| UNC Medical Center | Durham | North Carolina | Recruiting |
| Duke University | Durham | North Carolina | Recruiting |
| The Christ Hospital- Cincinnati | Cincinnati | Ohio | Recruiting |
| University of Cincinnati | Cincinnati | Ohio | Recruiting |
| University Hospital (Cleveland) | Cleveland | Ohio | Recruiting |
| Providence St. Vincent's - Portland | Portland | Oregon | Recruiting |
| Oregon Health Science Portland | Portland | Oregon | Recruiting |
| Penn State Health | Hershey | Pennsylvania | Recruiting |
| UPMC | Pittsburgh | Pennsylvania | Recruiting |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | Recruiting |
| PRISMA Health- Upstate | Greenville | South Carolina | Recruiting |
| Sanford | Sioux Falls | South Dakota | Recruiting |
| Vanderbilt | Nashville | Tennessee | Recruiting |
| Austin Heart | Austin | Texas | Recruiting |
| Medical City Healthcare Dallas | Dallas | Texas | Recruiting |
| Baylor Scott & White -Dallas | Dallas | Texas | Recruiting |
| Baylor/Texas Heart | Houston | Texas | Recruiting |
| Methodist San Antonio | San Antonio | Texas | Recruiting |
| Baylor - Temple | Temple | Texas | Recruiting |
+ 8 more sites — see the full list on the official registry below.
More Endotronix, Inc. trials in Ireland
Other trials for the same condition
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 NCT05934487 on ClinicalTrials.gov ↗ ← All trials in Ireland