Actively Recruiting
PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III
Led by Endotronix, Inc. · Updated on 2026-01-12
1750
Participants Needed
49
Research Sites
509 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject has given written informed consent
- Male or female, at least 18 years of age
- Diagnosis and treatment of heart failure for at least 3 months and NYHA Class II or III at time of screening
- Receiving appropriate medical therapy for heart failure according to current guidelines for at least 30 days prior to screening
- NYHA II Cohort: heart failure-related hospitalization within 6 months, at least 30 days before screening
- NYHA III Cohort: heart failure-related hospitalization within 12 months, at least 30 days before screening
- On diuretic therapy (at least 40 mg furosemide or equivalent) for at least 1 month at screening
- Physically able to hold the myCordella™ Patient Reader against the chest for up to 2 minutes daily while seated
- Sufficient eyesight, hearing, and mental capacity to operate the myCordella™ Patient Reader
- Sufficient cellular and/or Wi-Fi internet coverage at home
- Agree to return for all scheduled follow-up visits and hospital visits if needed
You will not qualify if you...
- ACC/AHA Stage D refractory heart failure, including recent IV inotropic therapy within 6 months
- History of recurrent pulmonary embolism (2 or more episodes within 5 years) or recent deep vein thrombosis in access veins within 3 months
- Resting systolic blood pressure below 90 mmHg or severe pre-capillary pulmonary hypertension (pulmonary artery systolic pressure ≥70 mmHg with wedge pressure ≤15 mmHg)
- Major cardiovascular event (e.g., heart attack, stroke) within 3 months prior to screening
- Unrepaired severe valvular disease
- Significant unrepaired congenital heart disease or mechanical/tissue right heart valves preventing sensor implantation
- Known coagulation disorders
- Allergy or hypersensitivity to platelet aggregation inhibitors or inability to take dual antiplatelet or anticoagulant therapy for one month post-implant
- History of life-threatening allergy to contrast dye
- Contraindications to right heart catheterization
- Active infection at time of sensor implant
- Severe kidney impairment (GFR <20 ml/min) or chronic dialysis
- Recent cardiac device implantation or valve repair/replacement within specified timeframes
- Expected to receive advanced therapies such as mechanical support or transplant within 24 months
- Pregnant or breastfeeding
- Unwilling or unable to comply with study protocol
- Severe illness limiting survival to less than 2 years
- Investigator deems subject unsuitable
- Enrolled in another investigational trial with active treatment arm
- In custody by legal authority or court order
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 49 locations
1
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
Actively Recruiting
2
USC
Los Angeles, California, United States, 90033
Actively Recruiting
3
UCSF Medical Center
San Francisco, California, United States, 94143
Actively Recruiting
4
Baptist Health South Florida
Miami, Florida, United States, 33176
Actively Recruiting
5
Ascension Sacred Heart
Pensacola, Florida, United States, 32504
Actively Recruiting
6
Piedmont
Atlanta, Georgia, United States, 30309
Actively Recruiting
7
Advocate Health System
Downers Grove, Illinois, United States, 60515
Active, Not Recruiting
8
Heart Care Centers of Illinois (HCCI)
Palos Park, Illinois, United States, 60464
Actively Recruiting
9
Ascension St. Vincent's
Indianapolis, Indiana, United States, 46260
Actively Recruiting
10
University of Kansas Medical Center (KUMC)
Kansas City, Kansas, United States, 66160
Actively Recruiting
11
University of Maryland
Baltimore, Maryland, United States, 21201
Active, Not Recruiting
12
MedStar
Baltimore, Maryland, United States, 21239
Actively Recruiting
13
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
14
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, United States, 02215
Active, Not Recruiting
15
Ascension Providence Hospital Cardiology - Heart Cardiology
Howell, Michigan, United States, 48843
Actively Recruiting
16
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407
Active, Not Recruiting
17
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
18
Centra Care Heart Center
Saint Cloud, Minnesota, United States, 56303
Actively Recruiting
19
St. Lukes/ Mid-American Heart Institute
Kansas City, Missouri, United States, 64111
Actively Recruiting
20
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
21
Mount Sinai West
New York, New York, United States, 10019
Actively Recruiting
22
Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
23
Lenox Hill/ Northwell Health
New York, New York, United States, 10075
Actively Recruiting
24
Stony Brook University Med Center
Stony Brook, New York, United States, 11794
Actively Recruiting
25
Duke University
Durham, North Carolina, United States, 27710
Actively Recruiting
26
The Christ Hospital- Cincinnati
Cincinnati, Ohio, United States, 45219
Active, Not Recruiting
27
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Actively Recruiting
28
University Hospital (Cleveland)
Cleveland, Ohio, United States, 44106
Actively Recruiting
29
Providence St. Vincent's - Portland
Portland, Oregon, United States, 97225
Actively Recruiting
30
Oregon Health Science Portland
Portland, Oregon, United States, 97239
Active, Not Recruiting
31
Penn State Health
Hershey, Pennsylvania, United States, 17033
Active, Not Recruiting
32
UPMC
Pittsburgh, Pennsylvania, United States, 15213
Active, Not Recruiting
33
PRISMA Health- Upstate
Greenville, South Carolina, United States, 29605
Active, Not Recruiting
34
Sanford
Sioux Falls, South Dakota, United States, 57105
Actively Recruiting
35
Vanderbilt
Nashville, Tennessee, United States, 37232
Actively Recruiting
36
Austin Heart
Austin, Texas, United States, 78756
Active, Not Recruiting
37
Medical City Healthcare Dallas
Dallas, Texas, United States, 75240
Actively Recruiting
38
Baylor Scott & White -Dallas
Fort Worth, Texas, United States, 76110
Actively Recruiting
39
Baylor/Texas Heart
Houston, Texas, United States, 77030
Active, Not Recruiting
40
Methodist San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
41
Baylor - Temple
Temple, Texas, United States, 76508
Actively Recruiting
42
University of Vermont
Burlington, Vermont, United States, 05401
Active, Not Recruiting
43
Providence Everett
Everett, Washington, United States, 98201
Actively Recruiting
44
West Virginia University
Morgantown, West Virginia, United States, 26506
Active, Not Recruiting
45
University of Wisconsin
Madison, Wisconsin, United States, 53792
Actively Recruiting
46
Advocate Aurora St. Luke's
Milwaukee, Wisconsin, United States, 53215
Active, Not Recruiting
47
AZORG Aalst
Aalst, Aalst, Belgium, 9300
Active, Not Recruiting
48
UZ Brussel
Brussels, Belgium
Not Yet Recruiting
49
University Hospital Galway
Galway, Ireland
Not Yet Recruiting
Research Team
A
Andrea Sauerland
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
8
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