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RECRUITING NA

PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III

NCT05934487 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DEVICE Cordella™ Pulmonary Artery Sensor System

Study Locations (20)

Minnesota

  • Minneapolis Heart Institute Foundation — Minneapolis
  • University of Minnesota — Minneapolis
  • Centra Care Heart Center — Saint Cloud

California

  • USC — Los Angeles
  • UCSF Medical Center — San Francisco

Florida

  • Baptist Health South Florida — Miami
  • Ascension Sacred Heart — Pensacola

Illinois

  • Advocate Health System — Downers Grove
  • Heart Care Centers of Illinois (HCCI) — Palos Park

Maryland

  • University of Maryland — Baltimore
  • MedStar — Baltimore

Massachusetts

  • Tufts Medical Center — Boston
  • Beth Israel Deaconess Medical Center (BIDMC) — Boston

Missouri

  • St. Lukes/ Mid-American Heart Institute — Kansas City
  • Washington University — St Louis

Arizona

  • St. Joseph's Hospital and Medical Center — Phoenix

Trial Details

FieldValue
Enrollment Target 1,750 participants
Start Date 2023-11-29
Est. Completion 2033-09
Phase NA

Sponsor

Endotronix

34 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05934487

The ClinicalTrials.gov registry entry for NCT05934487 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,750 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Endotronix, which has 34 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Heart Failure appearing as the primary indexed condition, and to 1 intervention — of which Cordella™ Pulmonary Artery Sensor System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05934487 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Minnesota, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05934487 about?

NCT05934487 is a clinical study titled "PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III". 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 sa...

What is the current status of trial NCT05934487?

This trial is currently recruiting. It is a NA study. The enrollment target is 1,750 participants. The study started on 2023-11-29. Estimated completion is 2033-09.

What conditions does trial NCT05934487 study?

This clinical trial studies the following conditions: Heart Failure, Heart Failure NYHA Class III, Heart Failure NYHA Class II. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05934487?

The interventions under investigation include: Cordella™ Pulmonary Artery Sensor System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05934487?

This trial is sponsored by Endotronix, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05934487 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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