PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III
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.
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
- 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
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05934487 live on ClinicalTrials.gov.