- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04089059
PROACTIVE-HF IDE Trial Heart Failure NYHA Class III (PROACTIVE-HF)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Aalst, Belgium
- Cardiovascular Center OLV Aalst
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Antwerp, Belgium
- ZNA Middlheim
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Genk, Belgium
- Ziekenhuis- Oost Limburg
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Ronse, Belgium
- AZ Glorieux Ronse
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Galway, Ireland
- University Hospital Galway
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Alabama
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Birmingham, Alabama, United States, 35235
- Ascension St Vincent's
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Huntsville, Alabama, United States, 35801
- Huntsville Hospital
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Arizona
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Phoenix, Arizona, United States, 85018
- Phoenix Cardiovascular Research Group/Insight
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California
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Loma Linda, California, United States, 92354
- Loma Linda University
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Rancho Mirage, California, United States, 92270
- Eisenhower Medical Center
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San Diego, California, United States, 92037
- UCSD
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San Francisco, California, United States, 94143
- UCSF Medical Center
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San Francisco, California, United States, 94118
- Kaiser San Francisco
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Santa Clara, California, United States, 95051
- Kaiser Santa Clara
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Colorado
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Littleton, Colorado, United States, 80120
- South Denver Cardiology
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Connecticut
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Hartford, Connecticut, United States, 06102
- Hartford Hospital
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Florida
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Miami, Florida, United States, 33176
- Baptist Health South Florida
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Pensacola, Florida, United States, 32504
- Ascension Sacred Heart
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Tampa, Florida, United States, 33609
- USF Health
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Weston, Florida, United States, 33331
- Cleveland Clinic
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Georgia
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Athens, Georgia, United States, 30600
- Piedmont Athens
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Hawaii
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Honolulu, Hawaii, United States, 96813
- Queens Medical Center
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern
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Chicago, Illinois, United States, 60637
- U of Chicago
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Palos Park, Illinois, United States, 60464
- Heart Centers of Illinois
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Peoria, Illinois, United States, 61107
- OSF Healthcare
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Indiana
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Indianapolis, Indiana, United States, 46260
- Ascension St Vincent's
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa Medical Center
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Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center (KUMC)
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Kentucky
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Louisville, Kentucky, United States, 40202
- University of Louisville
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Louisiana
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New Orleans, Louisiana, United States, 70121
- Ochsner Medical Center
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland
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Baltimore, Maryland, United States, 21239
- MedStar
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Massachusetts
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Boston, Massachusetts, United States, 02111
- Tufts Medical Center
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center (BIDMC)
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Boston, Massachusetts, United States, 02215
- Brigham and Women's Hospital (Mass General Brigham)
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Hospital
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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Minneapolis, Minnesota, United States, 55407
- Minneapolis Heart Institute Foundation
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Saint Cloud, Minnesota, United States, 56303
- Centra Care Heart Center
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Missouri
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Kansas City, Missouri, United States, 64111
- St. Lukes/ Mid-American Heart Institute
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Hackensack University Medical Center
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Ridgewood, New Jersey, United States, 07450
- The Valley Hospital
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New York
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New York, New York, United States, 10029
- Mount Sinai
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New York, New York, United States, 11794
- NYU Langone Health
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Queens, New York, United States, 11355
- New York Presbyterian Queens
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Stony Brook, New York, United States, 11794
- Stony Brook University Med Center
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Ohio
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Cincinnati, Ohio, United States, 45267
- University of Cincinnati
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Columbus, Ohio, United States, 43210
- Ohio State University
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health Science Portland
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Pennsylvania
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Abington, Pennsylvania, United States, 19001
- Thomas Jefferson Abington
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Hershey, Pennsylvania, United States, 17033
- Penn State Health
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Philadelphia, Pennsylvania, United States, 19104
- Penn Medicine
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Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson
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Pittsburgh, Pennsylvania, United States, 15213
- UPMC
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South Carolina
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Columbia, South Carolina, United States, 29203
- PRISMA Midlands - Palmetto
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Greenville, South Carolina, United States, 29605
- PRISMA Health- Upstate
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South Dakota
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Sioux Falls, South Dakota, United States, 57105
- Sanford
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Tennessee
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Knoxville, Tennessee, United States, 37934
- Tennova Healthcare (Turkey Creek Medical Center)
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Nashville, Tennessee, United States, 37232
- Vanderbilt
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Texas
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Austin, Texas, United States, 78756
- Austin Heart
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Gonzales, Texas, United States, 78155
- Craig Cardiovascular Center
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Houston, Texas, United States, 77030
- Houston Methodist
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Houston, Texas, United States, 77030
- Baylor/Texas Heart
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Houston, Texas, United States, 77030
- University of Texas/Hermann Memorial
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Round Rock, Texas, United States, 78655
- Baylor - Round Rock
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San Antonio, Texas, United States, 78229
- Methodist Healthcare System
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Temple, Texas, United States, 76508
- Baylor - Temple
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Vermont
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Burlington, Vermont, United States, 05401
- University of Vermont
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Virginia
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Norfolk, Virginia, United States, 22191
- Sentara Healthcare
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Winchester, Virginia, United States, 22601
- Valley Health System/Winchester Medical Center
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Washington
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Seattle, Washington, United States, 98196
- University of Washington
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Spokane, Washington, United States, 99204
- Providence Health Care
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West Virginia
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Morgantown, West Virginia, United States, 26506
- West Virginia University
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Wisconsin
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Madison, Wisconsin, United States, 53792
- University of Wisconsin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria
- Subject has given written informed consent
- Male or female, at least 18 years of age
- Diagnosis and treatment of HF (regardless of left ventricular ejection fraction (LVEF)) for ≥ 3 months and NYHA Class III HF at time of Screening
- 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.
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:
- Subjects with LVEF ≤ 50%: NT-proBNP ≥ 1500 pg/mL.
- 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
- Subjects should be on diuretic therapy
- 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
- 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
- Subject has sufficient Cellular and/ or Wi- Fi Internet coverage at home
- 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
- Intolerance to all neuro-hormonal antagonists (i.e., intolerance to ACE-I, ARB, ARNI, and beta-blockers) due to hypotension or renal dysfunction
- ACC/AHA Stage D refractory HF (including having received or currently receiving pharmacologic circulatory support with inotropes)
- 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)
- Subjects who have had a major cardiovascular (CV) event (e.g. myocardial infarction, stroke) within 3 months of the Screening Visit
- Unrepaired severe valvular disease
- 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)
- Subjects with known coagulation disorders
- 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
- Known history of life threatening allergy to contrast dye
- Subjects whereby RHC is contraindicated
- Subjects with an active infection at the Sensor Implant Visit
- Subjects with a Glomerular Filtration Rate (GFR) <25 ml/min or who are on chronic renal dialysis
- Implanted with Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P) or CRT-Defibrillator (CRT-D) for less than 90 days prior to screening visit
- Received or are likely to receive an advanced therapy (e.g. mechanical circulatory support or lung or heart transplant) in the next 12 months
- Subjects who are pregnant or breastfeeding
- 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
- Severe illness, other than heart disease, which would limit survival to <1 year
- Subjects whose clinical condition, in the opinion of the Investigator, makes them 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: Treatment Arm
Pulmonary Artery Pressure Guided Heart Failure Management (PAPGHFM) and Guideline Directed Medical Therapy (GDMT) considering daily Pulmonary Artery Pressure (PAP) measurements and vital signs collected by Cordella Heart Failure System (CHFS).
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The Cordella PA Sensor System (CorPASS) is intended to measure, record, and transmit pulmonary artery pressure (PAP) data from NYHA Class III heart failure patients at home to clinicians for assessment and patient-centered heart failure management and comprises of seven subsystems that operate together to take daily Pulmonary Artery Pressure (PAP) readings at a patient's home and transmit the results to a care provider for evaluation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy 6 month incidence of HF related Hospitalizations (HFH) or all-cause mortality
Time Frame: 6 months
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6 month incidence of HF related Hospitalizations (HFH) or all- cause mortality compared to a Performance Goal
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6 months
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Safety: Freedom from device/system related complication
Time Frame: 6 months
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Freedom from device/system related complication at 6 months
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6 months
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Safety: Freedom from pressure sensor failure
Time Frame: 6 months
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Freedom from pressure sensor failure at 6 months
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HF Hospitalizations
Time Frame: 6 months and 12 months
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Number of HF Hospitalizations at 6 and 12 months post-implant compared to the number of HF Hospitalizations in the 6 and 12 months prior to implant
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6 months and 12 months
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HF Hospitalizations or Emergency Department/Hospital Outpatient IV diuretic visits.
Time Frame: 6 and 12 months
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Comparison of the number of HF Hospitalizations, Emergency Department/ Hospital Outpatient IV diuretic visits of Cohort #1 and Cohort #2 at 6 and 12 months post implant at 6 months, added together with equal weighting into a total number of events
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6 and 12 months
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Mortality
Time Frame: 3 years
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Cardiac and all-cause mortality
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3 years
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IV diuretic visits
Time Frame: 3 years
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Intravenous (IV) diuretic visits
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3 years
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Pulmonary Artery Pressure (PAP)
Time Frame: 6 and 12 months
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Change in PAP: a. From Baseline through 6 and 12 months in subjects with a baseline mPAP i. above target range ii.
within or below target range iii.
Overall b.
Before and after 6-Minute Walk Test
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6 and 12 months
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Device success
Time Frame: 3 years
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Percentage of device success as documented by ability of the System to successfully transmit PAP data transmit PAP data
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3 years
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KCCQ
Time Frame: 3 years
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The Quality of Life KCCQ questionnaire is a measure of health-related quality of life.
It is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life related to Heart Failure.
Out of 23-items, 10 scores will be calculated: Physical Limitation, Symptom Stability, Symptom Frequency, Symptom Burden, Total Symptom Score, Self-Efficacy, Quality of Life, Social Limitation, Overall Summary Score, Clinical Summary Score .Presentation will be done by means of descriptive statistics including the absolute value and change from baseline by visit.
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3 years
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NYHA
Time Frame: 3 years
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Subjects complete a six (6) minute walk test at the study visits described in the study protocol.
Total distance walked (meters) will be collected and analyzed by means of descriptive statistics including the absolute value and change from baseline by visit
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3 years
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NYHA and 6-Minute Walk Test
Time Frame: 3 years
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Functional status improvement, as measured by NYHA and 6-Minute Walk Test
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3 years
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Serious adverse events
Time Frame: 3 years
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Frequency of serious adverse events throughout the study
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3 years
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Incidence of HF Hospitalizations or all-cause mortality
Time Frame: 12 months
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Incidence of HF Hospitalizations or all-cause mortality at 12 months
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12 months
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N-terminal pro B-type Natriuretic Peptide (NT-proBNP
Time Frame: 6 and 12 months
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Change of N-terminal pro B-type Natriuretic Peptide (NT-proBNP) from Baseline through 6 and 12 months
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6 and 12 months
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Days Alive and Out of Hospital (DAOH)
Time Frame: 3 years
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Days Alive and Out of Hospital (DAOH)
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3 years
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Heart failure related Medication changes
Time Frame: 3 years
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Heart failure related Medication changes
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3 years
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HF Hospitalization or all-cause mortality
Time Frame: 12 months
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Incidence of HF Hospitalizations or all-cause mortality at 12 months
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12 months
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HF Hospitalization, Emergency Department/Hospital Outpatient IV diuretic visits, all-cause mortality
Time Frame: 6 months
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Combined outcome of:
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6 months
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HF Hospitalization, Emergency Department/Hospital Outpatient IV diuretic visits
Time Frame: 6 and 12 months
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HF Hospitalization, Emergency Department/Hospital Outpatient IV diuretic visits at 6 and 12 months
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6 and 12 months
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Implant procedure and procedure related adverse events and serious adverse events
Time Frame: 3 years
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Frequency of implant procedure and procedure related adverse events and serious adverse events
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3 years
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Andrea Sauerland, Endotronix, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ETX-HFS-PA-03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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-
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-
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