Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)

PHASE3RecruitingINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

July 14, 2025

Primary Completion Date

August 31, 2027

Study Completion Date

December 31, 2027

Conditions
Acute Decompensated Heart Failure
Interventions
DEVICE

Reprieve System

The Reprieve System is a hospital bedside fluid management console designed to provide personalized and automated infusion of the IV diuretic furosemide and physiological saline in response to the patient's real-time urine output to safely and rapidly decongest patients suffering from Acute Decompensated Heart Failure.

DRUG

furosemide infusion

Participants randomized to ODT will be treated with guided diuretic titration, as recommended in the ESC guidelines on diuretic therapy

Trial Locations (27)

27157

RECRUITING

Atrium Health Wake Forest Baptist Medical Center, Winston-Salem

27401

NOT_YET_RECRUITING

Moses H. Cone Memorial Hospital, Greensboro

27710

NOT_YET_RECRUITING

Duke University, Durham

28000

RECRUITING

Hospital Ramon y Cajal, Madrid

29605

RECRUITING

Prisma Health Greenville Memorial Hospital, Greenville

30501

RECRUITING

Northeast Georgia Medical Center, Gainesville

32610

RECRUITING

University of Florida, Gainesville

38677

RECRUITING

University of Mississippi, Jackson

43210

RECRUITING

Ohio State University Hospital, Columbus

44106

RECRUITING

UH Cleveland Medical Center, Cleveland

RECRUITING

University Hospital Cleveland, Cleveland

45219

RECRUITING

Lindner Center at Christ Hospital, Cincinnati

45573

RECRUITING

University Hospital Wroclaw, Wroclaw

46000

RECRUITING

Clínico Universitario de Valencia, Valencia

RECRUITING

Hospital General Valencia, Valencia

48073

RECRUITING

Corewell William Beaumont University Hospital, Royal Oak

48197

RECRUITING

Trinity Health Ann Arbor Hospital, Ann Arbor

55407

RECRUITING

Minneapolis Heart Institute, Minneapolis

63130

RECRUITING

St. Louis VA, St Louis

RECRUITING

Washington University, St Louis

70445

RECRUITING

Medical University of Lodz, Lodz

73120

RECRUITING

Oklahoma Heart Hospital, Oklahoma City

75246

RECRUITING

Baylor Scott and White, Dallas

77030

RECRUITING

Baylor College of Medicine Ben Taub Hospital, Houston

92697

RECRUITING

University of California Irvine, Irvine

98104

RECRUITING

UW Harborview, Seattle

191904

RECRUITING

University of Pennsylvania, Philadelphia

All Listed Sponsors
lead

Reprieve Cardiovascular, Inc

INDUSTRY

NCT06898515 - Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258) | Biotech Hunter | Biotech Hunter