PROACTIVE-HF IDE Trial Heart Failure NYHA Class III
- Conditions
- Heart Failure NYHA Class III
- Interventions
- Device: Cordella™ Pulmonary Artery Sensor System
- Registration Number
- NCT04089059
- Lead Sponsor
- Endotronix, Inc.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 738
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Arm Cordella™ Pulmonary Artery Sensor System 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).
- Primary Outcome Measures
Name Time Method Safety: Freedom From Device/System Related Complication 6 months A device/system related complication (DSRC) is defined as an AE that is, or is possibly, related to the device/system (Cordella PA Sensor or electronic components) and is either treated invasively (other than intramuscular medication or diagnostic RHC) or results in subject´s death or explant of the device. The first primary safety endpoint describes freedom from a DSRC through 6 months and was tested against the null rate of 90%.
Safety: Freedom From Pressure Sensor Failure 6 months A pressure sensor failure (PSF) occurs when the sensor malfunctions to the point that no readings can be obtained from the sensor after all attempts are exhausted including troubleshooting the system to rule out any problems with the electronic components. The second primary safety endpoint describes freedom from Pressure Sensor Failure through 6 months, it was tested against the null rate of 95%.
Efficacy 6 Month Incidence of HF Related Hospitalizations (HFH) or All-cause Mortality 6 months The primary efficacy endpoint was the 6-month incidence of HF related hospitalizations or all-cause mortality in the modified Intent-to-Treat (mITT) population. As per the approved protocol/CIP, for study success the upper confidence bound of the observed event rate in the mITT population was required to be less than the performance goal (PG) of 0.43 events per patient 6-month, or equivalently, the corresponding p-value from the hypothesis test of 6-month incidence rate compared to PG was less than 0.025. Furthermore, the observed incidence rate was required to be less than 0.37. The 6-month incidence rate was derived using a Poisson regression with the number of events as the dependent variable and the exposure time as an offset term. In these analyses, a subject's exposure time was defined as the time to death, early study discontinuation, or 6 months (whichever occurred first).
- Secondary Outcome Measures
Name Time Method HF Hospitalizations 6 Months prior to implant and 6 months post implant Number of HF Hospitalizations at 6 months post-implant compared to the number of HF Hospitalizations in the 6 months prior to implant
HF Hospitalizations or Emergency Department/Hospital Outpatient IV Diuretic Visits. 6 months Incidence rate of HF Hospitalizations, Emergency Department/ Hospital Outpatient IV diuretic visits of Former Control Arm and Modified Intent to Treat at 6 months post implant, added together with equal weighting into a total number of events.
Mortality 6 Months Cardiac and all-cause mortality
IV Diuretic Visits 6 Months Intravenous (IV) diuretic visits
Pulmonary Artery Pressure (PAP) 6 months Change in PAP: a. From Baseline through 6 months in subjects with a baseline mPAP i. above target range ii. within or below target range iii. Overall
Device Success 6 Months Proportion of device success as documented by ability of the System to successfully transmit PAP data transmit PAP data
Kansas City Cardiomyopathy Questionnaire (KCCQ) 6 Months 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. From 23-items, the Overall Summary Score (OSS) will be calculated. In the OSS, each of the 23 items are converted onto a 0 to 100 scale using this formula: (Raw score - Minimum Raw Score)/(Maximum Raw Score - Minimum Raw Score) \* 100. Then these are averaged across the 23 items. A score of 100 (the maximum score) would indicate maximum quality of life relating to heart failure and a score of 0 (scale minimum) would indicate the worst possible quality of life relating to heart failure, with higher scores generally indicating higher quality of life.
NYHA 6 Months New York Heart Association (NYHA) Classification at 6 months. The New York Heart Association (NYHA) Classification provides a way of classifying the extent of heart failure by classifying patients in one of four categories based on their limitations during physical activity and in degree of shortness of breath and or angina pain. Class I is the least severe and Class IV is the most severe. The classes are:
Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.
Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.
Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances. Comfortable only at rest.
Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.6-Minute Walk Test 6 Months Functional status improvement, as measured by 6-Minute Walk Test total distance walked. The 6-Minute Walk Test (6MWT) is a test that measures the total distance an individual can walk on a flat, hard surface in 6 minutes. It is commonly used to evaluate functional exercise capacity in patients with conditions including heart failure. The minimum score possible is 0, which would represent an inability to walk any distance. There is no maximum score, as a patient could theoretically walk any distance in 6 minutes though 800 meters considered the top reference range, which is what would be expected by elite athletes. Higher score indicate greater higher exercise capacity and lower scores indicate lower exercise capacity.
Number and Percent of Patients With Serious Adverse Events 6 Months Number and percent of patients with serious adverse events throughout the study (site-reported).
Incidence of HF Hospitalizations or All-cause Mortality 12 months Incidence of HF Hospitalizations or all-cause mortality at 12 months calculated from Poisson regression.
N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) 6 months Change of N-terminal pro B-type Natriuretic Peptide (NT-proBNP) from Baseline through 6 months. NT-proBNP is a biomarker used to assess heart failure (HF). NT-proBNP levels vary widely and are reported in picograms per milliliter (pg/mL) or nanograms per liter (ng/L), with no predefined maximum value. Zero is a hypothetical minimum value though this is, in practice, not possible. In the current context, higher scores indicate more severe heart failure and lower levels indicate less severe heart failure.
Days Alive and Out of Hospital (DAOH) 6 Months Days Alive and Out of Hospital (DAOH) during the 6 months after implant
Number of Heart Failure Related Medication Changes 6 Months Number of patients (%) with heart failure related medication changes in the 6 months after implant
Number of HF Hospitalization or All-cause Mortality 12 months Number of HF Hospitalizations or all-cause mortality at 12 months
Number of HF Hospitalization, Emergency Department/Hospital Outpatient IV Diuretic Visits, All-cause Mortality 6 months Number of combined outcome of:
1. First and recurrent Heart Failure Hospitalizations
2. Emergency Department / Hospital Outpatient IV diuretic visits all-cause mortality at 6 months, added together with equal weighting into a total number of events.Number of HF Hospitalization, Emergency Department/Hospital Outpatient IV Diuretic Visits 6 months Number of HF Hospitalization, Emergency Department/Hospital Outpatient IV diuretic visits at 6 months.
Implant Procedure and Procedure Related Adverse Events and Serious Adverse Events 6 months Frequency of implant procedure and procedure related adverse events and serious adverse events
Trial Locations
- Locations (73)
Ascension St Vincent's
🇺🇸Indianapolis, Indiana, United States
Huntsville Hospital
🇺🇸Huntsville, Alabama, United States
Phoenix Cardiovascular Research Group/Insight
🇺🇸Phoenix, Arizona, United States
Loma Linda University
🇺🇸Loma Linda, California, United States
Eisenhower Medical Center
🇺🇸Rancho Mirage, California, United States
UCSD
🇺🇸San Diego, California, United States
Kaiser San Francisco
🇺🇸San Francisco, California, United States
UCSF Medical Center
🇺🇸San Francisco, California, United States
Kaiser Santa Clara
🇺🇸Santa Clara, California, United States
South Denver Cardiology
🇺🇸Littleton, Colorado, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Baptist Health South Florida
🇺🇸Miami, Florida, United States
Cardiovascular Center OLV Aalst
🇧🇪Aalst, Belgium
U of Chicago
🇺🇸Chicago, Illinois, United States
ZNA Middlheim
🇧🇪Antwerp, Belgium
Ascension Sacred Heart
🇺🇸Pensacola, Florida, United States
USF Health
🇺🇸Tampa, Florida, United States
Cleveland Clinic
🇺🇸Weston, Florida, United States
Piedmont Athens
🇺🇸Athens, Georgia, United States
Queens Medical Center
🇺🇸Honolulu, Hawaii, United States
Northwestern
🇺🇸Chicago, Illinois, United States
Heart Centers of Illinois
🇺🇸Palos Park, Illinois, United States
OSF Healthcare
🇺🇸Peoria, Illinois, United States
University of Iowa Medical Center
🇺🇸Iowa City, Iowa, United States
University of Kansas Medical Center (KUMC)
🇺🇸Kansas City, Kansas, United States
University Of Louisville
🇺🇸Louisville, Kentucky, United States
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Medstar
🇺🇸Baltimore, Maryland, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center (BIDMC)
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hospital (Mass General Brigham)
🇺🇸Boston, Massachusetts, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Centra Care Heart Center
🇺🇸Saint Cloud, Minnesota, United States
St. Lukes/ Mid-American Heart Institute
🇺🇸Kansas City, Missouri, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
The Valley Hospital
🇺🇸Ridgewood, New Jersey, United States
Mount Sinai
🇺🇸New York, New York, United States
NYU Langone Health
🇺🇸New York, New York, United States
New York Presbyterian Queens
🇺🇸Queens, New York, United States
Stony Brook University Med Center
🇺🇸Stony Brook, New York, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Oregon Health Science Portland
🇺🇸Portland, Oregon, United States
Thomas Jefferson Abington
🇺🇸Abington, Pennsylvania, United States
Penn State Health
🇺🇸Hershey, Pennsylvania, United States
Penn Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Thomas Jefferson
🇺🇸Philadelphia, Pennsylvania, United States
UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
PRISMA Midlands - Palmetto
🇺🇸Columbia, South Carolina, United States
PRISMA Health- Upstate
🇺🇸Greenville, South Carolina, United States
Sanford
🇺🇸Sioux Falls, South Dakota, United States
Tennova Healthcare (Turkey Creek Medical Center)
🇺🇸Knoxville, Tennessee, United States
Vanderbilt
🇺🇸Nashville, Tennessee, United States
Austin Heart
🇺🇸Austin, Texas, United States
Craig Cardiovascular Center
🇺🇸Gonzales, Texas, United States
Baylor/Texas Heart
🇺🇸Houston, Texas, United States
Houston Methodist
🇺🇸Houston, Texas, United States
University of Texas/Hermann Memorial
🇺🇸Houston, Texas, United States
Baylor - Round Rock
🇺🇸Round Rock, Texas, United States
Methodist Healthcare System
🇺🇸San Antonio, Texas, United States
Baylor - Temple
🇺🇸Temple, Texas, United States
University of Vermont
🇺🇸Burlington, Vermont, United States
Sentara Healthcare
🇺🇸Norfolk, Virginia, United States
Valley Health System/Winchester Medical Center
🇺🇸Winchester, Virginia, United States
University of Washington
🇺🇸Seattle, Washington, United States
Providence Health Care
🇺🇸Spokane, Washington, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Ziekenhuis- Oost Limburg
🇧🇪Genk, Belgium
University Hospital Galway
🇮🇪Galway, Ireland