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NCT04089059 · ClinicalTrials.gov registry record · NA
PROACTIVE-HF IDE Trial Heart Failure NYHA Class III
A NA study of Heart Failure NYHA Class III, sponsored by Endotronix.
- Active
- Registry status
- NA
- Development phase
- 738
- Enrollment target
- 20
- Study locations
NCT04089059: Active NA study of Heart Failure NYHA Class III, sponsored by Endotronix.
NCT04089059 is a NA study of Heart Failure NYHA Class III that is active but no longer recruiting, run by Endotronix. The registered enrollment target is 738 participants, roughly in line with the 763-participant average among 9 other Heart Failure NYHA Class III trials with a reported enrollment target. The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04089059, a NA study of Heart Failure NYHA Class III, is active but no longer recruiting, sponsored by Endotronix.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 738 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
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 t
Conditions Studied
Interventions
- DEVICE Cordella™ Pulmonary Artery Sensor System
Study Locations (20)
California
- Loma Linda University - Loma Linda
- Eisenhower Medical Center - Rancho Mirage
- UCSD - San Diego
- Kaiser San Francisco - San Francisco
- UCSF Medical Center - San Francisco
- Kaiser Santa Clara - Santa Clara
Florida
- Baptist Health South Florida - Miami
- Ascension Sacred Heart - Pensacola
- USF Health - Tampa
- Cleveland Clinic - Weston
Illinois
- Northwestern - Chicago
- U of Chicago - Chicago
- Heart Centers of Illinois - Palos Park
Alabama
- Ascension St Vincent's - Birmingham
- Huntsville Hospital - Huntsville
Arizona
- Phoenix Cardiovascular Research Group/Insight - Phoenix
Colorado
- South Denver Cardiology - Littleton
Connecticut
- Hartford Hospital - Hartford
Georgia
- Piedmont Athens - Athens
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 738 participants |
| Start Date | 2020-01-10 |
| Est. Completion | 2028-04 |
| Phase | NA |
What the registry record for NCT04089059 still lists
NCT04089059 is an interventional study that assigns participants to a tested intervention. The registered 738 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 763-participant average among 9 other Heart Failure NYHA Class III trials with a reported enrollment target.
The record links to 1 condition, with Heart Failure NYHA Class III appearing as the primary indexed condition, and to 1 intervention - of which Cordella™ Pulmonary Artery Sensor System is the first listed.
NCT04089059 names 20 study sites across 9 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT04089059 about?
NCT04089059 is a clinical study titled "PROACTIVE-HF IDE Trial Heart Failure NYHA Class III". 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).
What is the current status of trial NCT04089059?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 738 participants. The study started on 2020-01-10. Estimated completion is 2028-04.
What conditions does trial NCT04089059 study?
This clinical trial studies the following conditions: Heart Failure NYHA Class III.
What interventions are being tested in trial NCT04089059?
The interventions under investigation include: Cordella™ Pulmonary Artery Sensor System (DEVICE).
Who is sponsoring clinical trial NCT04089059?
This trial is sponsored by Endotronix, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04089059 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Failure NYHA Class III
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04089059's enrollment target sits among peer trials
738 4th of 9 higher than 6 of 9 other Heart Failure NYHA Class III trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure NYHA Class III trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III
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-
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-
An Early Feasibility Study Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure
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-
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-
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RECRUITING · NA
-
Hemodynamic-GUIDEd Management of Heart Failure
COMPLETED · NA
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