PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III
Start Date
11/29/2023
Completion Date
9/1/2033
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Cordella™ Pulmonary Artery Sensor System
Conditions
Locations
St. Joseph's Hospital and Medical Center
Phoenix, Arizona 85013
United States
USC
Los Angeles, California 90033
United States
UCSF Medical Center
San Francisco, California 94143
United States
Baptist Health South Florida
Miami, Florida 33176
United States
Ascension Sacred Heart
Pensacola, Florida 32504
United States
Piedmont
Atlanta, Georgia 30309
United States
Advocate Health System
Downers Grove, Illinois 60515
United States
Heart Care Centers of Illinois (HCCI)
Palos Park, Illinois 60464
United States
Ascension St. Vincent's
Indianapolis, Indiana 46260
United States
University of Kansas Medical Center (KUMC)
Kansas City, Kansas 66160
United States
MedStar
Baltimore, Maryland 21239
United States
Tufts Medical Center
Boston, Massachusetts 02111
United States
Boston Medical Center Corporation
Boston, Massachusetts 02118
United States
Ascension Providence Hospital Cardiology - Heart Cardiology
Howell, Michigan 48843
United States
University of Minnesota
Minneapolis, Minnesota 55455
United States
Centra Care Heart Center
Saint Cloud, Minnesota 56303
United States
St. Lukes/ Mid-American Heart Institute
Kansas City, Missouri 64111
United States
Mount Sinai West
New York, New York 10019
United States
Mount Sinai
New York, New York 10029
United States
Lenox Hill/ Northwell Health
New York, New York 10075
United States
Stony Brook University Med Center
Stony Brook, New York 11794
United States
UNC Medical Center
Durham, North Carolina 27703
United States
Duke University
Durham, North Carolina 27710
United States
The Christ Hospital- Cincinnati
Cincinnati, Ohio 45219
United States
University of Cincinnati
Cincinnati, Ohio 45267
United States
University Hospital (Cleveland)
Cleveland, Ohio 44106
United States
Providence St. Vincent's - Portland
Portland, Oregon 97225
United States
Oregon Health Science Portland
Portland, Oregon 97239
United States
Penn State Health
Hershey, Pennsylvania 17033
United States
UPMC
Pittsburgh, Pennsylvania 15213
United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina 29425
United States
PRISMA Health- Upstate
Greenville, South Carolina 29605
United States
Sanford
Sioux Falls, South Dakota 57105
United States
Vanderbilt
Nashville, Tennessee 37232
United States
Austin Heart
Austin, Texas 78756
United States
Medical City Healthcare Dallas
Dallas, Texas 75240
United States
Baylor Scott & White -Dallas
Dallas, Texas 75246
United States
Baylor/Texas Heart
Houston, Texas 77030
United States
Methodist San Antonio
San Antonio, Texas 78229
United States
Baylor - Temple
Temple, Texas 76508
United States
University of Vermont
Burlington, Vermont 05401
United States
Providence Everett
Everett, Washington 98201
United States
West Virginia University
Morgantown, West Virginia 26506
United States
University of Wisconsin
Madison, Wisconsin 53792
United States
Advocate Aurora St. Luke's
Milwaukee, Wisconsin 53215
United States
AZORG Aalst
Aalst, 9300
Belgium
UZ Brussel
Brussels,
Belgium
University Hospital Galway
Galway,
Ireland