PROACTIVE-HF IDE Trial Heart Failure NYHA Class III

NAActive, not recruitingINTERVENTIONAL
Enrollment

738

Participants

Timeline

Start Date

January 10, 2020

Primary Completion Date

April 30, 2028

Study Completion Date

April 30, 2028

Conditions
Heart Failure NYHA Class III
Interventions
DEVICE

Cordella™ Pulmonary Artery Sensor System

"The Cordella PA Sensor System (CorPASS) is intended to measure, record, and transmit pulmonary artery pressure (PAP) data from NYHA Class III heart failure patients at home to clinicians for assessment and patient-centered heart failure management and comprises of seven subsystems that operate together to take daily Pulmonary Artery Pressure (PAP) readings at a patient's home and transmit the results to a care provider for evaluation.~1. Cordella Sensor~2. Cordella Delivery System~3. myCordella Patient Reader~4. Reader Dock~5. Cordella Calibration Equipment (CalEQ)~6. myCordella Hub~7. Cordella Data Analysis Platform (CDAP)"

Trial Locations (74)

10029

Mount Sinai, New York

11355

New York Presbyterian Queens, Queens

11794

NYU Langone Health, New York

Stony Brook University Med Center, Stony Brook

15213

UPMC, Pittsburgh

17033

Penn State Health, Hershey

19001

Thomas Jefferson Abington, Abington

19104

Penn Medicine, Philadelphia

19107

Thomas Jefferson, Philadelphia

21201

University of Maryland, Baltimore

21239

Medstar, Baltimore

22191

Sentara Healthcare, Norfolk

22601

Valley Health System/Winchester Medical Center, Winchester

26506

West Virginia University, Morgantown

29203

PRISMA Midlands - Palmetto, Columbia

29605

PRISMA Health- Upstate, Greenville

30600

Piedmont Athens, Athens

32504

Ascension Sacred Heart, Pensacola

33176

Baptist Health South Florida, Miami

33331

Cleveland Clinic, Weston

33609

USF Health, Tampa

35235

Ascension St Vincent's, Birmingham

35801

Huntsville Hospital, Huntsville

37232

Vanderbilt, Nashville

37934

Tennova Healthcare (Turkey Creek Medical Center), Knoxville

40202

University Of Louisville, Louisville

43210

Ohio State University, Columbus

45267

University of Cincinnati, Cincinnati

46260

Ascension St Vincent's, Indianapolis

48202

Henry Ford Hospital, Detroit

52242

University of Iowa Medical Center, Iowa City

53792

University of Wisconsin, Madison

55407

Minneapolis Heart Institute Foundation, Minneapolis

55455

University of Minnesota, Minneapolis

56303

Centra Care Heart Center, Saint Cloud

57105

Sanford, Sioux Falls

60464

Heart Centers of Illinois, Palos Park

60611

Northwestern, Chicago

60637

U of Chicago, Chicago

61107

OSF Healthcare, Peoria

64111

St. Lukes/ Mid-American Heart Institute, Kansas City

66160

University of Kansas Medical Center (KUMC), Kansas City

70121

Ochsner Medical Center, New Orleans

76508

Baylor - Temple, Temple

77030

Baylor/Texas Heart, Houston

Houston Methodist, Houston

University of Texas/Hermann Memorial, Houston

78155

Craig Cardiovascular Center, Gonzales

78229

Methodist Healthcare System, San Antonio

78655

Baylor - Round Rock, Round Rock

78756

Austin Heart, Austin

80120

South Denver Cardiology, Littleton

85018

Phoenix Cardiovascular Research Group/Insight, Phoenix

92037

UCSD, San Diego

92270

Eisenhower Medical Center, Rancho Mirage

92354

Loma Linda University, Loma Linda

94118

Kaiser San Francisco, San Francisco

94143

UCSF Medical Center, San Francisco

95051

Kaiser Santa Clara, Santa Clara

96813

Queens Medical Center, Honolulu

97239

Oregon Health Science Portland, Portland

98196

University of Washington, Seattle

99204

Providence Health Care, Spokane

06102

Hartford Hospital, Hartford

02111

Tufts Medical Center, Boston

02215

Beth Israel Deaconess Medical Center (BIDMC), Boston

Brigham and Women's Hospital (Mass General Brigham), Boston

07601

Hackensack University Medical Center, Hackensack

07450

The Valley Hospital, Ridgewood

05401

University of Vermont, Burlington

Unknown

Cardiovascular Center OLV Aalst, Aalst

ZNA Middlheim, Antwerp

Ziekenhuis- Oost Limburg, Genk

University Hospital Galway, Galway

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Endotronix, Inc.

INDUSTRY