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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
1,750
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, with the goal of reducing heart failure hospitalizations. The system 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. Cordella Sensor Cordella Delivery System myCordella Patient Reader Reader Dock Cordella Calibration Equipment (CalEQ) myCordella Tablet Cordella Data Analysis Platform (CDAP)
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
RECRUITINGUSC
Los Angeles, California, United States
RECRUITINGUCSF Medical Center
San Francisco, California, United States
RECRUITINGBaptist Health South Florida
Miami, Florida, United States
Efficacy- NYHA II Cohort - A composite of first HF event or death from Cardiovascular Death up to 24 months.
A composite endpoint of first HF event or death from CVD up to 24 months.
Time frame: 24 months
Efficacy- NYHA III Cohort (Phase I) - a composite of HF events or death from cardiovascular disease at 6 months
A composite of HF events or death from cardiovascular disease at 6 months
Time frame: 12 months
Safety- Randomized Arm- Freedom from device/system related complication
Freedom from device/system related complication at 24 months
Time frame: 24 months
Safety- Randomized Arm-Freedom from pressure sensor failure
Freedom from pressure sensor failure at 24 months
Time frame: 24 months
Safety- Single Arm-Freedom from device/system related complication
Freedom from device/system related complication at 12 months
Time frame: 12 months
Safety- Single Arm- Freedom from pressure sensor failure
Freedom from pressure sensor failure at 12 months
Time frame: 12 months
Efficacy- NYHA III Cohort (Phase II) - A test of non-inferiority at 12 months of the percentage of patients at or below trend seated mPAP of 25 mmHg in (i) Clinician-Directed Patient Self-Management vs. (ii) Clinician Management Arm
A test of non-inferiority at 12 months of the percentage of patients at or below trend seated mPAP of 25 mmHg in (i) Clinician-Directed Patient Self-Management vs. (ii) Clinician Management Arm
Time frame: 12 months
Efficacy - NYHA II Cohort & NYHA III Cohort - HF Hospitalizations
-Incidence of HFH at 12, 18, and 24 months
Time frame: 12 months, 18 months and 24 months
Efficacy - NYHA II Cohort & NYHA III Cohort- HF Hospitalizations
-Number of HFH at 12- and 24-months post-implant compared to the number of HFH in the 12 and 24 months prior to implant
Time frame: 12 months and 24 months
Efficacy - NYHA II Cohort & NYHA III Cohort - HF Hospitalizations
Combined outcome of : 1. First and recurrent HF Hospitalizations 2. Urgent HF Visits 3. all-cause mortality
Time frame: 12 month
Efficacy - NYHA II Cohort & NYHA III Cohort - HF Hospitalizations
Length of stay
Time frame: Duration of study (to 5 years)
Efficacy - NYHA II Cohort & NYHA III Cohort - All-cause mortality
All-cause mortality
Time frame: Duration of study (to 5 years)
Efficacy - NYHA II Cohort & NYHA III Cohort - Death from cardiovascular disease
Death from cardiovascular disease
Time frame: Duration of study (to 5 years)
Efficacy - NYHA II Cohort & NYHA III Cohort - Urgent HF visits
Urgent HF visits
Time frame: Duration of study (to 5 years)
Efficacy - NYHA II Cohort - Incidence of HF hospitalizations or all-cause mortality
Incidence of HF hospitalizations or all-cause mortality
Time frame: 12 months
Efficacy - NYHA III Cohort - Composite of first HF event (HF hospitalization or urgent HF visit or death from cardiovascular disease (CVD)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Ascension Sacred Heart
Pensacola, Florida, United States
RECRUITINGPiedmont
Atlanta, Georgia, United States
RECRUITINGAdvocate Health System
Downers Grove, Illinois, United States
ACTIVE_NOT_RECRUITINGHeart Care Centers of Illinois (HCCI)
Palos Park, Illinois, United States
RECRUITINGAscension St. Vincent's
Indianapolis, Indiana, United States
RECRUITINGUniversity of Kansas Medical Center (KUMC)
Kansas City, Kansas, United States
RECRUITING...and 39 more locations
Composite of first HF event (HF hospitalization or urgent HF visit or
Time frame: Up to 24 months
Eff-NYHA II Cohort & NYHA III Cohort -time to death, # HFH or urgent HF visits, time to first HFH or urgent HF visit, diff >/= 15 KCCQ BSL to 24 mos,diff >/= 10 in KCCQ BSL to 24 mos, diff >/= 5 in KCCQ BSL to 24 mos, diff >/= 30m in 6 MWT BSL to 24 mos
-time to death, # HFH or urgent HF visits, time to first HFH or urgent HF visit, diff \>/= 15 KCCQ BSL to 24 mos,diff \>/= 10 in KCCQ BSL to 24 mos, diff \>/= 5 in KCCQ BSL to 24 mos, diff \>/= 30m in 6 MWT BSL to 24 mos
Time frame: Duration of study (to 5 years)
Efficacy - NYHA II Cohort & NYHA III Cohort - Various measurements via ECHO and evaluated by ECHO core lab at Baseline, 12, 24, 36, 48 and 60 months.
Various measurements via ECHO and evaluated by ECHO core lab at Baseline, 12, 24, 36, 48 and 60 months.
Time frame: Duration of study (to 5 years)
Efficacy - NYHA II Cohort & NYHA III Cohort - Heart failure related medication changes
Heart failure related medication changes
Time frame: Duration of study (to 5 years)
Efficacy - NYHA II Cohort & NYHA III Cohort - Change in PAP from baseline
Change in PAP from baseline
Time frame: Duration of study (to 5 years)
Efficacy - NYHA II Cohort & NYHA III Cohort - Change in PAP from baseline as measured by echocardiogram (ECHO) and evaluated by anECHO core lab at 12, 24, 36, 48, and 60 months
Change in PAP from baseline as measured by echocardiogram (ECHO) and evaluated by an ECHO core lab at 12, 24, 36, 48, and 60 months
Time frame: Duration of study (to 5 years)
Efficacy - NYHA II Cohort & NYHA III Cohort - Patient Outcome Measures as measured by KCCQ, Brief Illness Perception Questionnaire, andEuroQol-5 Dimensions-5 Level (EQ-5D-5L)
Patient Outcome Measures as measured by KCCQ, Brief Illness Perception Questionnaire, and EuroQol-5 Dimensions-5 Level (EQ-5D-5L)
Time frame: Duration of study (to 5 years)
Efficacy - NYHA II Cohort & NYHA III Cohort - Functional status improvement as measured by NYHA classification and 6MWT
Functional status improvement as measured by NYHA classification and 6MWT
Time frame: Duration of study (to 5 years)
Efficacy - NYHA II Cohort & NYHA III Cohort - HFH stratified by ejection fraction (HFrEF, HFmrEF, HFpEF, and HF recovered EF) and baselineenrollment ECHO estimated systolic PAP
HFH stratified by ejection fraction (HFrEF,
Time frame: Duration of study (to 5 years)
Efficacy - NYHA II Cohort & NYHA III Cohort - Mortality by baseline EF (HFrEF, HFmrEF, HFpEF, HF recovered EF), and baseline enrollmentECHO estimated systolic PAP
Mortality by baseline EF (HFrEF, HFmrEF,
Time frame: Duration of study (to 5 years)
Efficacy - NYHA II Cohort & NYHA III Cohort - Days alive outside hospital (DAOH)
Days alive outside hospital (DAOH)
Time frame: Duration of study (to 5 years)
Efficacy - NYHA II Cohort & NYHA III Cohort - Health Economic Analysis
Health Economic Analysis
Time frame: Duration of study (to 5 years)
Efficacy - NYHA II Cohort & NYHA III Cohort - Adherence to regular PAP and vital sign measurements including a sub-analysis on subjectswho move to another area of the country
Adherence to regular PAP and vital sign measurements including a sub-analysis on subjects who move to another area of the country
Time frame: Duration of study (to 5 years)
Safety - NYHA II Cohort - Freedom from device/system related complications at 12 months
Freedom from device/system related complications at 12 months
Time frame: Duration of study (to 5 years)
Safety - NYHA III Cohort - Freedom from pressure sensor failure at 12 months
Freedom from pressure sensor failure at 12 months
Time frame: Duration of study (to 5 years)
Safety - NYHA II Cohort & NYHA III Cohort - Pressure sensor failure rate throughout the study
Pressure sensor failure rate throughout the study
Time frame: Duration of study (to 5 years)
Safety - NYHA II Cohort & NYHA III Cohort - Frequency of serious adverse events throughout the study
Frequency of serious adverse events throughout the study
Time frame: Duration of study (to 5 years)
Safety - NYHA II Cohort & NYHA III Cohort - Frequency of implant procedure and procedure related adverse events and serious adverse events
Frequency of implant procedure and procedure related adverse events and serious adverse events
Time frame: Duration of study (to 5 years)
Safety - NYHA III Cohort - Freedom from device/system related complications at 24 months
Freedom from device/system related complications at 24 months
Time frame: Duration of study (to 5 years)
Safety - NYHA III Cohort - Freedom from pressure sensor failure at 24 months
Freedom from pressure sensor failure at 24 months
Time frame: Duration of study (to 5 years)