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Recruiting Not applicable Interventional

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

ClinicalTrials.gov ID: NCT05934487

Public ClinicalTrials.gov record NCT05934487. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 12:45 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Prospective, Multi-Center, Open Label, Randomized Control Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class II-III Heart Failure Patients

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05934487
Recruitment status
Recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
Endotronix, Inc.
Industry
Enrollment
1,750 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 28, 2023
Primary completion
Aug 31, 2028
Completion
Aug 31, 2033
Last update posted
Jun 28, 2026

2023 – 2033

United States locations

U.S. sites
45
U.S. states
25
U.S. cities
38
Facility City State ZIP Site status
St. Joseph's Hospital and Medical Center Phoenix Arizona 85013 Recruiting
USC Los Angeles California 90033 Recruiting
UCSF Medical Center San Francisco California 94143 Recruiting
Baptist Health South Florida Miami Florida 33176 Recruiting
Ascension Sacred Heart Pensacola Florida 32504 Recruiting
Piedmont Atlanta Georgia 30309 Recruiting
Advocate Health System Downers Grove Illinois 60515 Recruiting
Heart Care Centers of Illinois (HCCI) Palos Park Illinois 60464 Recruiting
Ascension St. Vincent's Indianapolis Indiana 46260 Recruiting
University of Kansas Medical Center (KUMC) Kansas City Kansas 66160 Recruiting
MedStar Baltimore Maryland 21239 Recruiting
Tufts Medical Center Boston Massachusetts 02111 Recruiting
Boston Medical Center Corporation Boston Massachusetts 02118 Not yet recruiting
Ascension Providence Hospital Cardiology - Heart Cardiology Howell Michigan 48843 Recruiting
University of Minnesota Minneapolis Minnesota 55455 Recruiting
Centra Care Heart Center Saint Cloud Minnesota 56303 Recruiting
St. Lukes/ Mid-American Heart Institute Kansas City Missouri 64111 Recruiting
Mount Sinai West New York New York 10019 Recruiting
Mount Sinai New York New York 10029 Recruiting
Lenox Hill/ Northwell Health New York New York 10075 Recruiting
Stony Brook University Med Center Stony Brook New York 11794 Recruiting
UNC Medical Center Durham North Carolina 27703 Recruiting
Duke University Durham North Carolina 27710 Recruiting
The Christ Hospital- Cincinnati Cincinnati Ohio 45219 Recruiting
University of Cincinnati Cincinnati Ohio 45267 Recruiting
University Hospital (Cleveland) Cleveland Ohio 44106 Recruiting
Providence St. Vincent's - Portland Portland Oregon 97225 Recruiting
Oregon Health Science Portland Portland Oregon 97239 Recruiting
Penn State Health Hershey Pennsylvania 17033 Recruiting
UPMC Pittsburgh Pennsylvania 15213 Recruiting
Medical University of South Carolina (MUSC) Charleston South Carolina 29425 Recruiting
PRISMA Health- Upstate Greenville South Carolina 29605 Recruiting
Sanford Sioux Falls South Dakota 57105 Recruiting
Vanderbilt Nashville Tennessee 37232 Recruiting
Austin Heart Austin Texas 78756 Recruiting
Medical City Healthcare Dallas Dallas Texas 75240 Recruiting
Baylor Scott & White -Dallas Dallas Texas 75246 Recruiting
Baylor/Texas Heart Houston Texas 77030 Recruiting
Methodist San Antonio San Antonio Texas 78229 Recruiting
Baylor - Temple Temple Texas 76508 Recruiting
University of Vermont Burlington Vermont 05401 Recruiting
Providence Everett Everett Washington 98201 Recruiting
West Virginia University Morgantown West Virginia 26506 Recruiting
University of Wisconsin Madison Wisconsin 53792 Recruiting
Advocate Aurora St. Luke's Milwaukee Wisconsin 53215 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05934487, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 28, 2026 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05934487 live on ClinicalTrials.gov.

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