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NCT05934487 · ClinicalTrials.gov registry record · NA
PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III
A NA study of Heart Failure and Heart Failure NYHA Class III, sponsored by Endotronix.
- Recruiting
- Registry status
- NA
- Development phase
- 1,750
- Enrollment target
- 20
- Study locations
NCT05934487: Recruiting NA study of Heart Failure and Heart Failure NYHA Class III, sponsored by Endotronix.
NCT05934487 is a NA study of Heart Failure and Heart Failure NYHA Class III that is actively recruiting participants, run by Endotronix. The registered enrollment target is 1,750 participants, below the 2,045-participant average among 397 other Heart Failure trials with a reported enrollment target (14% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05934487, a NA study of Heart Failure and Heart Failure NYHA Class III, is actively recruiting participants, sponsored by Endotronix.
- RECRUITING
- Registry status
- NA
- Development phase
- 1,750 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
A composite endpoint of first HF event or death from CVD up to 24 months.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 1,750 participants |
| Start Date | 2023-11-29 |
| Est. Completion | 2033-09 |
| Phase | NA |
What NCT05934487 shows while recruiting
NCT05934487 is an interventional study that assigns participants to a tested intervention. Its 1,750 participants enrollment target places it among the larger protocols in the corpus, below the 2,045-participant average among 397 other Heart Failure trials with a reported enrollment target (14% lower).
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.
NCT05934487 names 20 study sites across 12 states, led by Minnesota, California, Florida.
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.
What interventions are being tested in trial NCT05934487?
The interventions under investigation include: Cordella™ Pulmonary Artery Sensor System (DEVICE).
Who is sponsoring clinical trial NCT05934487?
This trial is sponsored by Endotronix, which has 4 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Heart Failure
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 NCT05934487's enrollment target sits among peer trials
1,750 48th of 397 higher than 349 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure 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
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