Clinical trial NCT04089059: PROACTIVE-HF IDE Trial Heart Failure NYHA Class III
Official title: A Prospective, Multi-Center, Open Label, Single Arm Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in NYHA Class III Heart Failure Patients (PROACTIVE- HF Trial)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heart Failure NYHA Class III
Keywords: Heart Failure
Heart Disease
Cardiovascular Disease
Pulmonary Artery Pressure
Lead sponsor: Endotronix, Inc.
Sponsor class: INDUSTRY
First posted: 2019-09-13
Enrollment: 738
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a prospective, open- label, single arm, multicenter clinical trial to evaluate the safety and effectiveness of the Cordella PA Sensor System in NYHA Class III Heart Failure Patients compared to a Performance Goal (PG).


Eligibility criteria: 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 left ventricular ejection fraction (LVEF)) for ≥ 3 months and NYHA Class III HF at time of Screening
4. Subjects should be on stable, optimally titrated medical therapy for at least 30 days, as recommended according to current American Heart Association (AHA)/American College of Cardiology (ACC) guidelines as standard-of-care for HF therapy in the United States, or current European Society of Cardiology (ESC) guidelines for HF treatment in Europe, with any intolerance documented.
5. HF related hospitalization, HF treatment in a hospital day-care setting, or urgent outpatient clinic HF visit for IV diuretics within 12 month (last hospitalization should be 30 days before Screening/Enrollment) and/or N-terminal pro B-type Natriuretic Peptide (NT proBNP) at time of Screening/ Enrollment defined as:

   1. Subjects with LVEF ≤ 50%: NT-proBNP ≥ 1500 pg/mL.
   2. Subjects with LVEF \> 50%: NT-proBNP ≥ 800 pg/mL . Thresholds for NT-proBNP (for both LVEF ≤ 50% and LVEF \> 50%) will be corrected for body mass index (BMI) using a 4% reduction per BMI unit over 25 kg/m2
6. Subjects should be on diuretic therapy
7. 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 minutes per day while in a seated position, as well as dock and undock the myCordella™ Patient Reader
8. Subjects with sufficient eyesight, hearing, and mental capacity to respond to the myCordella™ Patient Reader's audio/visual cues and operate the myCordella™ Patient Reader
9. Subject has sufficient Cellular and/ or Wi- Fi Internet coverage at home
10. Subject agrees to return to the treating Investigator for all scheduled follow up visits and can return to the hospital for follow up

Exclusion Criteria

1. Intolerance to all neuro-hormonal antagonists (i.e., intolerance to ACE-I, ARB, ARNI, and beta-blockers) due to hypotension or renal dysfunction
2. ACC/AHA Stage D refractory HF (including having received or currently receiving pharmacologic circulatory support with inotropes)
3. Subjects with history of recurrent pulmonary embolism ( ≥2 episodes within 5 years prior to Screening Visit) and/or deep vein thrombosis (\< 3 month prior to Screening Visit)
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 Sensor Implant Visit
12. Subjects with a Glomerular Filtration Rate (GFR) \<25 ml/min or who are on chronic renal dialysis
13. Implanted with Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P) or CRT-Defibrillator (CRT-D) for less than 90 days prior to screening visit
14. Received or are likely to receive an advanced therapy (e.g. mechanical circulatory support or lung or heart transplant) in the next 12 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 \<1 year
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

Primary outcomes:
measure: Efficacy 6 Month Incidence of HF Related Hospitalizations (HFH) or All-cause Mortality
timeFrame: 6 months
measure: Safety: Freedom From Device/System Related Complication
timeFrame: 6 months
measure: Safety: Freedom From Pressure Sensor Failure
timeFrame: 6 months
Secondary outcomes:
measure: HF Hospitalizations
timeFrame: 6 Months prior to implant and 6 months post implant
measure: HF Hospitalizations or Emergency Department/Hospital Outpatient IV Diuretic Visits.
timeFrame: 6 months
measure: Mortality
timeFrame: 6 Months
measure: IV Diuretic Visits
timeFrame: 6 Months
measure: Pulmonary Artery Pressure (PAP)
timeFrame: 6 months
measure: Device Success
timeFrame: 6 Months
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: 6 Months
measure: NYHA
timeFrame: 6 Months
measure: 6-Minute Walk Test
timeFrame: 6 Months
measure: Number and Percent of Patients With Serious Adverse Events
timeFrame: 6 Months
measure: Incidence of HF Hospitalizations or All-cause Mortality
timeFrame: 12 months
measure: N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)
timeFrame: 6 months
measure: Days Alive and Out of Hospital (DAOH)
timeFrame: 6 Months
measure: Number of Heart Failure Related Medication Changes
timeFrame: 6 Months
measure: Number of HF Hospitalization or All-cause Mortality
timeFrame: 12 months
measure: Number of HF Hospitalization, Emergency Department/Hospital Outpatient IV Diuretic Visits, All-cause Mortality
timeFrame: 6 months
measure: Number of HF Hospitalization, Emergency Department/Hospital Outpatient IV Diuretic Visits
timeFrame: 6 months
measure: Implant Procedure and Procedure Related Adverse Events and Serious Adverse Events
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Ascension St Vincent's
state: Alabama
city: Huntsville
country: United States
facility: Huntsville Hospital
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Cardiovascular Research Group/Insight
state: Arizona
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: Rancho Mirage
country: United States
facility: Eisenhower Medical Center
state: California
city: San Diego
country: United States
facility: UCSD
state: California
city: San Francisco
country: United States
facility: Kaiser San Francisco
state: California
city: San Francisco
country: United States
facility: UCSF Medical Center
state: California
city: Santa Clara
country: United States
facility: Kaiser Santa Clara
state: California
city: Littleton
country: United States
facility: South Denver Cardiology
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Miami
country: United States
facility: Baptist Health South Florida
state: Florida
city: Pensacola
country: United States
facility: Ascension Sacred Heart
state: Florida
city: Tampa
country: United States
facility: USF Health
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic
state: Florida
city: Athens
country: United States
facility: Piedmont Athens
state: Georgia
city: Honolulu
country: United States
facility: Queens Medical Center
state: Hawaii
city: Chicago
country: United States
facility: Northwestern
state: Illinois
city: Chicago
country: United States
facility: U of Chicago
state: Illinois
city: Palos Park
country: United States
facility: Heart Centers of Illinois
state: Illinois
city: Peoria
country: United States
facility: OSF Healthcare
state: Illinois
city: Indianapolis
country: United States
facility: Ascension St Vincent's
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Medical Center
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center (KUMC)
state: Kansas
city: Louisville
country: United States
facility: University Of Louisville
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Baltimore
country: United States
facility: Medstar
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center (BIDMC)
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital (Mass General Brigham)
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Saint Cloud
country: United States
facility: Centra Care Heart Center
state: Minnesota
city: Kansas City
country: United States
facility: St. Lukes/ Mid-American Heart Institute
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: New York
country: United States
facility: Mount Sinai
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Queens
country: United States
facility: New York Presbyterian Queens
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Med Center
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Portland
country: United States
facility: Oregon Health Science Portland
state: Oregon
city: Abington
country: United States
facility: Thomas Jefferson Abington
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Health
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
city: Columbia
country: United States
facility: PRISMA Midlands - Palmetto
state: South Carolina
city: Greenville
country: United States
facility: PRISMA Health- Upstate
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford
state: South Dakota
city: Knoxville
country: United States
facility: Tennova Healthcare (Turkey Creek Medical Center)
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt
state: Tennessee
city: Austin
country: United States
facility: Austin Heart
state: Texas
city: Gonzales
country: United States
facility: Craig Cardiovascular Center
state: Texas
city: Houston
country: United States
facility: Baylor/Texas Heart
state: Texas
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Houston
country: United States
facility: University of Texas/Hermann Memorial
state: Texas
city: Round Rock
country: United States
facility: Baylor - Round Rock
state: Texas
city: San Antonio
country: United States
facility: Methodist Healthcare System
state: Texas
city: Temple
country: United States
facility: Baylor - Temple
state: Texas
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
city: Norfolk
country: United States
facility: Sentara Healthcare
state: Virginia
city: Winchester
country: United States
facility: Valley Health System/Winchester Medical Center
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Spokane
country: United States
facility: Providence Health Care
state: Washington
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Aalst
country: Belgium
facility: Cardiovascular Center OLV Aalst
city: Antwerp
country: Belgium
facility: ZNA Middlheim
city: Genk
country: Belgium
facility: Ziekenhuis- Oost Limburg
city: Galway
country: Ireland
facility: University Hospital Galway
Study officials:
affiliation: Endotronix, Inc.
name: Andrea Sauerland
role: STUDY_DIRECTOR
References: