Active, not recruiting
Not applicable
PROACTIVE-HF IDE Trial Heart Failure NYHA Class III
Condition(s) studied
Heart Failure NYHA Class III
Investigational drug(s) / intervention(s)
Cordella™ Pulmonary Artery Sensor System
Cordella™ Pulmonary Artery Sensor System: 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.
1. Cordella Sensor
2. Cordella Delivery System
3. myCordella Patient Reader
4. Reader Dock
5. Cordella Calibration Equipment (CalEQ)
6. myCordella Hub
7. Cordella Data Analysis Platform (CDAP)
Study 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
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 outcome measure(s)
- 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).
- 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%.
Trial sites (74)
| Facility | City | Region | Status |
| Ascension St Vincent's |
Birmingham |
Alabama |
|
| Huntsville Hospital |
Huntsville |
Alabama |
|
| Phoenix Cardiovascular Research Group/Insight |
Phoenix |
Arizona |
|
| Loma Linda University |
Loma Linda |
California |
|
| Eisenhower Medical Center |
Rancho Mirage |
California |
|
| UCSD |
San Diego |
California |
|
| Kaiser San Francisco |
San Francisco |
California |
|
| UCSF Medical Center |
San Francisco |
California |
|
| Kaiser Santa Clara |
Santa Clara |
California |
|
| South Denver Cardiology |
Littleton |
Colorado |
|
| Hartford Hospital |
Hartford |
Connecticut |
|
| Baptist Health South Florida |
Miami |
Florida |
|
| Ascension Sacred Heart |
Pensacola |
Florida |
|
| USF Health |
Tampa |
Florida |
|
| Cleveland Clinic |
Weston |
Florida |
|
| Piedmont Athens |
Athens |
Georgia |
|
| Queens Medical Center |
Honolulu |
Hawaii |
|
| Northwestern |
Chicago |
Illinois |
|
| U of Chicago |
Chicago |
Illinois |
|
| Heart Centers of Illinois |
Palos Park |
Illinois |
|
| OSF Healthcare |
Peoria |
Illinois |
|
| Ascension St Vincent's |
Indianapolis |
Indiana |
|
| University of Iowa Medical Center |
Iowa City |
Iowa |
|
| University of Kansas Medical Center (KUMC) |
Kansas City |
Kansas |
|
| University Of Louisville |
Louisville |
Kentucky |
|
| Ochsner Medical Center |
New Orleans |
Louisiana |
|
| University of Maryland |
Baltimore |
Maryland |
|
| Medstar |
Baltimore |
Maryland |
|
| Tufts Medical Center |
Boston |
Massachusetts |
|
| Beth Israel Deaconess Medical Center (BIDMC) |
Boston |
Massachusetts |
|
| Brigham and Women's Hospital (Mass General Brigham) |
Boston |
Massachusetts |
|
| Henry Ford Hospital |
Detroit |
Michigan |
|
| Minneapolis Heart Institute Foundation |
Minneapolis |
Minnesota |
|
| University of Minnesota |
Minneapolis |
Minnesota |
|
| Centra Care Heart Center |
Saint Cloud |
Minnesota |
|
| St. Lukes/ Mid-American Heart Institute |
Kansas City |
Missouri |
|
| Hackensack University Medical Center |
Hackensack |
New Jersey |
|
| The Valley Hospital |
Ridgewood |
New Jersey |
|
| Mount Sinai |
New York |
New York |
|
| NYU Langone Health |
New York |
New York |
|
+ 34 more sites — see the full list on the official registry below.
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