Phase
Condition
Congestive Heart Failure
Heart Failure
Vascular Diseases
Treatment
Cordella™ Pulmonary Artery Sensor System
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria 1. Subject has given written informed consent 2. Male or female, at least 18 years of age 3. Diagnosis and treatment of HF (regardless of LVEF) for ≥ 3 months and NYHA Class II HF (NYHA II Cohort) or NYHA III (NYHA III Cohort) at time of Screening
Subjects should be receiving appropriate medical therapy for heart failure according to current AHA/ACC guidelines as standard-of-care for HF therapy in the United States, or current ESC guidelines for HF treatment in Europe for at least 30 days prior to the Screening/Enrollment visit. Stable is defined as no more than a 100% increase or 50% decrease in dose. These criteria may be waived if a subject is intolerant of ACE-I, ARB, ARNI), MRA, beta-blockers, or SGLT2i, subject is unable to afford these agents, subject has contraindications to these agents, or these agents are not indicated under the Guidelines. Such intolerance, lack of affordability, contraindications, or lack of indications must be documented.
HFrEF (EF < 50%): Subject has been on stable medications maximized to the subject'stolerance of ACE-I or ARB or ARNI, MRA, beta-blockers, and SGLT2i as determined bythe study investigator for at least 30 days prior to Screening/Enrollment
HFpEF (EF ≥ 50%): Subject has been on stable medication maximized to the subject'stolerance of SGLT2i as determined by the study investigator for at least 30 daysprior to Screening/Enrollment 5. NYHA II Cohort- HF related hospitalization within 6months (last hospitalization should be 30 days before Screening /Enrollment) 5. NYHAIII Cohort -HF related hospitalization within 12 month (last hospitalization shouldbe 30 days before Screening/Enrollment)
Subjects should be on diuretic therapy (≥40 mg] furosemide or equivalent) for ≥ 1month at time of Screening
Subjects who are physically able to hold the myCordella™ Patient Reader unit (approximate weight 1.3lb) against the ventral thoracic surface for up to 2 minutesper day while in a seated position, as well as dock and undock the myCordella™Patient Reader
Subjects with sufficient eyesight, hearing, and mental capacity to respond to themyCordella™ Patient Reader's audio/visual cues and operate the myCordella™ PatientReader
Subject has sufficient Cellular and/ or Wi- Fi Internet coverage at home
Subject agrees to return to the treating Investigator for all scheduled followup visits and can return to the hospital for follow up
Exclusion
Exclusion Criteria:
ACC/AHA Stage D refractory HF (including a known history of >24 hours of IVinotropic therapy to support circulation within the past 6 months (other thanrelation to a procedure))
Subjects with history of recurrent pulmonary embolism (≥2 episodes within 5years prior to Screening Visit) and/or deep vein thrombosis in the femoral orIJ vein used for access (< 3 month prior to Screening Visit)
Subjects with a resting systolic blood pressure <90 mmHg and/ or severepre-capillary pulmonary hypertension with a pulmonary artery systolic pressureof ≥70 mm/Hg with pulmonary capillary wedge pressure ≤ 15 mmHg at the CordellaPA Sensor Implant RHC (V2)
Subjects who have had a major cardiovascular (CV) event (e.g., myocardialinfarction, stroke) within 3 months of the Screening Visit
Unrepaired severe valvular disease
Subjects with significant congenital heart disease that has not been repairedand would prevent implantation of the Cordella PA Sensor or mechanical/tissueright heart valve(s)
Subjects with known coagulation disorders
Subjects with a hypersensitivity or allergy to platelet aggregation inhibitorsincluding aspirin, clopidogrel, prasugrel, and ticagrelor; or patients unableto take dual antiplatelet or anticoagulants for one-month post implant
Known history of life-threatening allergy to contrast dye.
Subjects whereby RHC is contraindicated
Subjects with an active infection at the Cordella Sensor Implant Visit
Subjects with a GFR <20 ml/min or who are on chronic renal dialysis
Implanted with Cardiac Resynchronization Therapy-Pacemaker (CRT-P) or CardiacResynchronization Therapy-Defibrillator (CRT-D), or having undergonemitral/tricuspid valve repair/replacement within 90 days or catheter ablationfor atrial fibrillation within 30 days prior to screening visit
Received or are likely to receive an advanced therapy (e.g., durable mechanicalcirculatory support or lung or heart transplant) in the next 24 months
Subjects who are pregnant or breastfeeding
Subjects who are unwilling or deemed by the Investigator to be unwilling tocomply with the study protocol, or subjects with a history of non-compliance
Severe illness, other than heart disease, which would limit survival to <2years
Subjects whose clinical condition, in the opinion of the Investigator, makesthem an unsuitable candidate for the study
Subjects enrolled in another investigational trial with an active Treatment Arm
Subject who is in custody by order of an authority or a court of law
Study Design
Connect with a study center
AZORG Aalst
Aalst 2803448, Aalst 9300
BelgiumActive - Recruiting
UZ Brussel
Brussels 2800866,
BelgiumActive - Recruiting
University Hospital Galway
Galway 2964180,
IrelandActive - Recruiting
St. Joseph's Hospital and Medical Center
Phoenix, Arizona 85013
United StatesSite Not Available
St. Joseph's Hospital and Medical Center
Phoenix 5308655, Arizona 5551752 85013
United StatesActive - Recruiting
Loma Linda University
Loma Linda, California 92354
United StatesSite Not Available
USC
Los Angeles, California 90033
United StatesSite Not Available
San Diego Cardiac Care
San Diego, California 92123
United StatesSite Not Available
UCSF Medical Center
San Francisco, California 94143
United StatesSite Not Available
USC
Los Angeles 5368361, California 5332921 90033
United StatesActive - Recruiting
UCSF Medical Center
San Francisco 5391959, California 5332921 94143
United StatesActive - Recruiting
South Denver Cardiology
Denver, Colorado 80210
United StatesSite Not Available
Baptist Health South Florida
Miami, Florida 33176
United StatesSite Not Available
Ascension Sacred Heart
Pensacola, Florida 32504
United StatesSite Not Available
Cleveland Clinic
Weston, Florida 33331
United StatesSite Not Available
Baptist Health South Florida
Miami 4164138, Florida 4155751 33176
United StatesActive - Recruiting
Ascension Sacred Heart
Pensacola 4168228, Florida 4155751 32504
United StatesActive - Recruiting
Piedmont
Atlanta, Georgia 30309
United StatesSite Not Available
Piedmont
Atlanta 4180439, Georgia 4197000 30309
United StatesActive - Recruiting
Northwestern
Chicago, Illinois 60611
United StatesSite Not Available
U of Chicago
Chicago, Illinois 60637
United StatesSite Not Available
Advocate Health System
Downers Grove, Illinois 60515
United StatesSite Not Available
Heart Care Centers of Illinois (HCCI)
Palos Park, Illinois 60464
United StatesSite Not Available
OSF Healthcare
Peoria, Illinois 61107
United StatesSite Not Available
Advocate Health System
Downers Grove 4890119, Illinois 4896861 60515
United StatesSite Not Available
Heart Care Centers of Illinois (HCCI)
Palos Park 4905265, Illinois 4896861 60464
United StatesActive - Recruiting
Ascension St. Vincent's
Indianapolis, Indiana 46260
United StatesSite Not Available
Ascension St. Vincent's
Indianapolis 4259418, Indiana 4921868 46260
United StatesActive - Recruiting
University of Iowa Medical Center
Iowa City, Iowa 52242
United StatesSite Not Available
University of Kansas Medical Center (KUMC)
Kansas City, Kansas 66160
United StatesSite Not Available
University of Kansas Medical Center (KUMC)
Kansas City 4273837, Kansas 4273857 66160
United StatesActive - Recruiting
St. Elizabeth's Healthcare
Edgewood, Kentucky 41017
United StatesSite Not Available
University Of Louisville
Louisville, Kentucky 40202
United StatesSite Not Available
MedStar
Baltimore, Maryland 21239
United StatesActive - Recruiting
University of Maryland
Baltimore, Maryland 21201
United StatesSite Not Available
MedStar
Baltimore 4347778, Maryland 4361885 21239
United StatesActive - Recruiting
University of Maryland
Baltimore 4347778, Maryland 4361885 21201
United StatesSite Not Available
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts 02215
United StatesSite Not Available
Tufts Medical Center
Boston, Massachusetts 02111
United StatesSite Not Available
Beth Israel Deaconess Medical Center (BIDMC)
Boston 4930956, Massachusetts 6254926 02215
United StatesSite Not Available
Tufts Medical Center
Boston 4930956, Massachusetts 6254926 02111
United StatesActive - Recruiting
Henry Ford Hospital
Detroit, Michigan 48202
United StatesSite Not Available
Ascension Providence Hospital Cardiology - Heart Cardiology
Howell, Michigan 48843
United StatesSite Not Available
Ascension Providence Hospital Cardiology - Heart Cardiology
Howell 4996655, Michigan 5001836 48843
United StatesActive - Recruiting
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota 55407
United StatesSite Not Available
University of Minnesota
Minneapolis, Minnesota 55455
United StatesActive - Recruiting
Centra Care Heart Center
Saint Cloud, Minnesota 56303
United StatesSite Not Available
Centra Care Heart Center
St. Cloud, Minnesota 56303
United StatesSite Not Available
Minneapolis Heart Institute Foundation
Minneapolis 5037649, Minnesota 5037779 55407
United StatesSite Not Available
University of Minnesota
Minneapolis 5037649, Minnesota 5037779 55455
United StatesActive - Recruiting
Centra Care Heart Center
Saint Cloud 5044407, Minnesota 5037779 56303
United StatesActive - Recruiting
St. Lukes/ Mid-American Heart Institute
Kansas City, Missouri 64111
United StatesActive - Recruiting
Washington University
Saint Louis, Missouri 63110
United StatesSite Not Available
St. Lukes/ Mid-American Heart Institute
Kansas City 4393217, Missouri 4398678 64111
United StatesActive - Recruiting
Washington University
St Louis 4407066, Missouri 4398678 63110
United StatesActive - Recruiting
University of Nebraska
Omaha, Nebraska 68198
United StatesSite Not Available
Lenox Hill/ Northwell Health
New York, New York 10075
United StatesActive - Recruiting
Mount Sinai
New York, New York 10029
United StatesActive - Recruiting
Mount Sinai West
New York, New York 10019
United StatesSite Not Available
NYU Langone Health
New York, New York 11794
United StatesSite Not Available
Stony Brook University Med Center
Stony Brook, New York 11794
United StatesSite Not Available
Lenox Hill/ Northwell Health
New York 5128581, New York 5128638 10075
United StatesActive - Recruiting
Mount Sinai
New York 5128581, New York 5128638 10029
United StatesActive - Recruiting
Mount Sinai West
New York 5128581, New York 5128638 10019
United StatesActive - Recruiting
Stony Brook University Med Center
Stony Brook 5139865, New York 5128638 11794
United StatesActive - Recruiting
Duke University
Durham, North Carolina 27710
United StatesSite Not Available
Duke University Medical Center
Durham, North Carolina 27710
United StatesSite Not Available
Duke University
Durham 4464368, North Carolina 4482348 27710
United StatesActive - Recruiting
The Christ Hospital- Cincinnati
Cincinnati, Ohio 45219
United StatesSite Not Available
University of Cincinnati
Cincinnati, Ohio 45267
United StatesActive - Recruiting
University Hospital (Cleveland)
Cleveland, Ohio 44106
United StatesSite Not Available
The Christ Hospital- Cincinnati
Cincinnati 4508722, Ohio 5165418 45219
United StatesSite Not Available
University of Cincinnati
Cincinnati 4508722, Ohio 5165418 45267
United StatesActive - Recruiting
University Hospital (Cleveland)
Cleveland 5150529, Ohio 5165418 44106
United StatesActive - Recruiting
Oregon Health Science Portland
Portland, Oregon 97239
United StatesSite Not Available
Providence St. Vincent's - Portland
Portland, Oregon 97225
United StatesSite Not Available
Oregon Health Science Portland
Portland 5746545, Oregon 5744337 97239
United StatesSite Not Available
Providence St. Vincent's - Portland
Portland 5746545, Oregon 5744337 97225
United StatesActive - Recruiting
TJ Abington
Abington, Pennsylvania 190001
United StatesSite Not Available
Penn State Health
Hershey, Pennsylvania 17033
United StatesSite Not Available
Penn Medicine (UPENN)
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
UPMC
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Penn State Health
Hershey 5193342, Pennsylvania 6254927 17033
United StatesSite Not Available
UPMC
Pittsburgh 5206379, Pennsylvania 6254927 15213
United StatesSite Not Available
PRISMA Midlands - Palmetto
Columbia, South Carolina 29203
United StatesSite Not Available
PRISMA Health- Upstate
Greenville, South Carolina 29605
United StatesSite Not Available
PRISMA Health- Upstate
Greenville 4580543, South Carolina 4597040 29605
United StatesSite Not Available
Sanford
Sioux Falls, South Dakota 57105
United StatesSite Not Available
Sanford
Sioux Falls 5231851, South Dakota 5769223 57105
United StatesActive - Recruiting
Vanderbilt
Nashville, Tennessee 37232
United StatesSite Not Available
Vanderbilt
Nashville 4644585, Tennessee 4662168 37232
United StatesActive - Recruiting
Austin Heart
Austin, Texas 78756
United StatesSite Not Available
Medical City Healthcare Dallas
Dallas, Texas 75240
United StatesSite Not Available
Baylor Scott & White -Dallas
Fort Worth, Texas 76110
United StatesSite Not Available
Baylor/Texas Heart
Houston, Texas 77030
United StatesSite Not Available
Methodist San Antonio
San Antonio, Texas 78229
United StatesSite Not Available
Baylor - Temple
Temple, Texas 76508
United StatesSite Not Available
Austin Heart
Austin 4671654, Texas 4736286 78756
United StatesSite Not Available
Medical City Healthcare Dallas
Dallas 4684888, Texas 4736286 75240
United StatesActive - Recruiting
Baylor Scott & White -Dallas
Fort Worth 4691930, Texas 4736286 76110
United StatesActive - Recruiting
Baylor/Texas Heart
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
Methodist San Antonio
San Antonio 4726206, Texas 4736286 78229
United StatesActive - Recruiting
Baylor - Temple
Temple 4735966, Texas 4736286 76508
United StatesActive - Recruiting
University of Vermont
Burlington, Vermont 05401
United StatesSite Not Available
University of Vermont
Burlington 5234372, Vermont 5242283 05401
United StatesSite Not Available
Sentara Healthcare
Norfolk, Virginia 22191
United StatesSite Not Available
Providence Everett
Everett, Washington 98201
United StatesSite Not Available
Providence Health Care
Spokane, Washington 99204
United StatesSite Not Available
Providence Everett
Everett 5793933, Washington 5815135 98201
United StatesActive - Recruiting
West Virginia University
Morgantown, West Virginia 26506
United StatesSite Not Available
West Virginia University
Morgantown 4815352, West Virginia 4826850 26506
United StatesSite Not Available
University of Wisconsin
Madison, Wisconsin 53792
United StatesSite Not Available
Advocate Aurora St. Luke's
Milwaukee, Wisconsin 53215
United StatesSite Not Available
University of Wisconsin
Madison 5261457, Wisconsin 5279468 53792
United StatesActive - Recruiting
Advocate Aurora St. Luke's
Milwaukee 5263045, Wisconsin 5279468 53215
United StatesSite Not Available

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