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PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III

NCT05934487

This study is recruiting at 44 US sites in 25 states, according to its ClinicalTrials.gov record last updated .

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Heart Failure NYHA Class II
  • Heart Failure NYHA Class III
  • Heart Failure

Eligibility basics and study details

Study type
Interventional
Phase
Not applicable
Ages
18 years and older
Sex
All
Healthy volunteers
Not accepted
Sponsor
Endotronix, Inc.
Last updated on ClinicalTrials.gov
June 29, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Arizona · 1

  • St. Joseph's Hospital and Medical Center · Phoenix, AZ

California · 2

  • USC · Los Angeles, CA
  • UCSF Medical Center · San Francisco, CA

Florida · 2

  • Baptist Health South Florida · Miami, FL
  • Ascension Sacred Heart · Pensacola, FL

Georgia · 1

  • Piedmont · Atlanta, GA

Illinois · 2

  • Advocate Health System · Downers Grove, IL
  • Heart Care Centers of Illinois (HCCI) · Palos Park, IL

Indiana · 1

  • Ascension St. Vincent's · Indianapolis, IN

Kansas · 1

  • University of Kansas Medical Center (KUMC) · Kansas City, KS

Maryland · 1

  • MedStar · Baltimore, MD

Massachusetts · 1

  • Tufts Medical Center · Boston, MA

Michigan · 1

  • Ascension Providence Hospital Cardiology - Heart Cardiology · Howell, MI

Minnesota · 2

  • University of Minnesota · Minneapolis, MN
  • Centra Care Heart Center · Saint Cloud, MN

Missouri · 1

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

New York · 4

  • Lenox Hill/ Northwell Health · New York, NY
  • Mount Sinai · New York, NY
  • Mount Sinai West · New York, NY
  • Stony Brook University Med Center · Stony Brook, NY

North Carolina · 2

  • Duke University · Durham, NC
  • UNC Medical Center · Durham, NC

Ohio · 3

  • The Christ Hospital- Cincinnati · Cincinnati, OH
  • University of Cincinnati · Cincinnati, OH
  • University Hospital (Cleveland) · Cleveland, OH

Oregon · 2

  • Oregon Health Science Portland · Portland, OR
  • Providence St. Vincent's - Portland · Portland, OR

Pennsylvania · 2

  • Penn State Health · Hershey, PA
  • UPMC · Pittsburgh, PA

South Carolina · 2

  • Medical University of South Carolina (MUSC) · Charleston, SC
  • PRISMA Health- Upstate · Greenville, SC

South Dakota · 1

  • Sanford · Sioux Falls, SD

Tennessee · 1

  • Vanderbilt · Nashville, TN

Texas · 6

  • Austin Heart · Austin, TX
  • Baylor Scott & White -Dallas · Dallas, TX
  • Medical City Healthcare Dallas · Dallas, TX
  • Baylor/Texas Heart · Houston, TX
  • Methodist San Antonio · San Antonio, TX
  • Baylor - Temple · Temple, TX

Vermont · 1

  • University of Vermont · Burlington, VT

Washington · 1

  • Providence Everett · Everett, WA

West Virginia · 1

  • West Virginia University · Morgantown, WV

Wisconsin · 2

  • University of Wisconsin · Madison, WI
  • Advocate Aurora St. Luke's · Milwaukee, WI

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.