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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 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.

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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).

Conditions Studied

Heart Failure NYHA Class III

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

FieldValue
Enrollment Target 738 participants
Start Date 2020-01-10
Est. Completion 2028-04
Phase NA

Sponsor

Endotronix

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04089059

The ClinicalTrials.gov registry entry for NCT04089059 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 738 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 763-participant average among 9 other Heart Failure NYHA Class III trials with a reported enrollment target. The listed sponsor is Endotronix, which has 4 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 9 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.