RECRUITING

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

Conditions

Heart Failure NYHA Class II Heart Failure NYHA Class III Heart Failure Heart Disease Cardiovascular Disease Pulmonary Artery Pressure

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Prospective, Multi-Center, Open Label, Randomized Control Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class II-III Heart Failure Patients

Quick Facts

Study Start:2023-11-29

Study Completion:2033-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05934487

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	1. ACC/AHA Stage D refractory HF (including a known history of \>24 hours of IV inotropic therapy to support circulation within the past 6 months (other than relation to a procedure)) 2. Subjects with history of recurrent pulmonary embolism (≥2 episodes within 5 years prior to Screening Visit) and/or deep vein thrombosis in the femoral or IJ vein used for access (\< 3 month prior to Screening Visit) 3. Subjects with a resting systolic blood pressure \<90 mmHg and/ or severe pre-capillary pulmonary hypertension with a pulmonary artery systolic pressure of ≥70 mm/Hg with pulmonary capillary wedge pressure ≤ 15 mmHg at the Cordella PA Sensor Implant RHC (V2) 4. Subjects who have had a major cardiovascular (CV) event (e.g., myocardial infarction, stroke) within 3 months of the Screening Visit 5. Unrepaired severe valvular disease 6. Subjects with significant congenital heart disease that has not been repaired and would prevent implantation of the Cordella PA Sensor or mechanical/tissue right heart valve(s) 7. Subjects with known coagulation disorders 8. Subjects with a hypersensitivity or allergy to platelet aggregation inhibitors including aspirin, clopidogrel, prasugrel, and ticagrelor; or patients unable to take dual antiplatelet or anticoagulants for one-month post implant 9. Known history of life-threatening allergy to contrast dye. 10. Subjects whereby RHC is contraindicated 11. Subjects with an active infection at the Cordella Sensor Implant Visit 12. Subjects with a GFR \<20 ml/min or who are on chronic renal dialysis 13. Implanted with Cardiac Resynchronization Therapy-Pacemaker (CRT-P) or Cardiac Resynchronization Therapy-Defibrillator (CRT-D), or having undergone mitral/tricuspid valve repair/replacement within 90 days or catheter ablation for atrial fibrillation within 30 days prior to screening visit 14. Received or are likely to receive an advanced therapy (e.g., durable mechanical circulatory support or lung or heart transplant) in the next 24 months 15. Subjects who are pregnant or breastfeeding 16. Subjects who are unwilling or deemed by the Investigator to be unwilling to comply with the study protocol, or subjects with a history of non-compliance 17. Severe illness, other than heart disease, which would limit survival to \<2 years 18. Subjects whose clinical condition, in the opinion of the Investigator, makes them an unsuitable candidate for the study 19. Subjects enrolled in another investigational trial with an active Treatment Arm 20. Subject who is in custody by order of an authority or a court of law

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

1. ACC/AHA Stage D refractory HF (including a known history of \>24 hours of IV inotropic therapy to support circulation within the past 6 months (other than relation to a procedure))
2. Subjects with history of recurrent pulmonary embolism (≥2 episodes within 5 years prior to Screening Visit) and/or deep vein thrombosis in the femoral or IJ vein used for access (\< 3 month prior to Screening Visit)
3. Subjects with a resting systolic blood pressure \<90 mmHg and/ or severe pre-capillary pulmonary hypertension with a pulmonary artery systolic pressure of ≥70 mm/Hg with pulmonary capillary wedge pressure ≤ 15 mmHg at the Cordella PA Sensor Implant RHC (V2)
4. Subjects who have had a major cardiovascular (CV) event (e.g., myocardial infarction, stroke) within 3 months of the Screening Visit
5. Unrepaired severe valvular disease
6. Subjects with significant congenital heart disease that has not been repaired and would prevent implantation of the Cordella PA Sensor or mechanical/tissue right heart valve(s)
7. Subjects with known coagulation disorders
8. Subjects with a hypersensitivity or allergy to platelet aggregation inhibitors including aspirin, clopidogrel, prasugrel, and ticagrelor; or patients unable to take dual antiplatelet or anticoagulants for one-month post implant
9. Known history of life-threatening allergy to contrast dye.
10. Subjects whereby RHC is contraindicated
11. Subjects with an active infection at the Cordella Sensor Implant Visit
12. Subjects with a GFR \<20 ml/min or who are on chronic renal dialysis
13. Implanted with Cardiac Resynchronization Therapy-Pacemaker (CRT-P) or Cardiac Resynchronization Therapy-Defibrillator (CRT-D), or having undergone mitral/tricuspid valve repair/replacement within 90 days or catheter ablation for atrial fibrillation within 30 days prior to screening visit
14. Received or are likely to receive an advanced therapy (e.g., durable mechanical circulatory support or lung or heart transplant) in the next 24 months
15. Subjects who are pregnant or breastfeeding
16. Subjects who are unwilling or deemed by the Investigator to be unwilling to comply with the study protocol, or subjects with a history of non-compliance
17. Severe illness, other than heart disease, which would limit survival to \<2 years
18. Subjects whose clinical condition, in the opinion of the Investigator, makes them an unsuitable candidate for the study
19. Subjects enrolled in another investigational trial with an active Treatment Arm
20. Subject who is in custody by order of an authority or a court of law

Contacts and Locations

Study Contact

Andrea Sauerland

CONTACT

(630) 473-3200

clinical@endotronix.com

Principal Investigator

Andrea Sauerland

STUDY_DIRECTOR

Endotronix, Inc.

Study Locations (Sites)

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

University of Maryland

Baltimore, Maryland, 21201

United States

MedStar

Baltimore, Maryland, 21239

United States

Tufts Medical Center

Boston, Massachusetts, 02111

United States

Beth Israel Deaconess Medical Center (BIDMC)

Boston, Massachusetts, 02215

United States

Ascension Providence Hospital Cardiology - Heart Cardiology

Howell, Michigan, 48843

United States

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407

United States

University of Minnesota

Minneapolis, Minnesota, 55455

United States

Centra Care Heart Center

St. Cloud, Minnesota, 56303

United States

St. Lukes/ Mid-American Heart Institute

Kansas City, Missouri, 64111

United States

Washington University

Saint Louis, Missouri, 63110

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

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

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

Fort Worth, Texas, 76110

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

Collaborators and Investigators

Sponsor: Endotronix, Inc.

Andrea Sauerland, STUDY_DIRECTOR, Endotronix, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-29

Study Completion Date2033-09

Study Record Updates

Study Start Date2023-11-29

Study Completion Date2033-09

Terms related to this study

Keywords Provided by Researchers

Heart Failure
Heart Disease
Cardiovascular Disease
Pulmonary Artery Pressure

Additional Relevant MeSH Terms

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