CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 738 enrolled
Drug / intervention
Cordella™ Pulmonary Artery Sensor Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04089059
NCT04089059N/AActive
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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)

Endotronix, Inc.·interventional·Posted Sep 13, 2019·Updated Jun 1, 2026

In Brief

A clinical study evaluating Cordella™ Pulmonary Artery Sensor System for Heart Failure NYHA Class III. Active but no longer recruiting, targeting 738 participants across 74 sites in 3 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure NYHA Class III
CountriesBelgium, Ireland, United States
Collaborators--

Timeline

N/AActive
202020212022202320242025202620272028
First PostedSep 13, 2019
Enrollment StartJan 10, 2020
Primary CompletionApr 1, 2028
TodayJul 2, 2026
Enrollment to primary: 8.2 yearsPosted 6.8 years agoPrimary completion in 1.7 years

Interventions

Cordella™ Pulmonary Artery Sensor Systemdevice

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)