| Primary | Efficacy 6 Month Incidence of HF Related Hospitalizations (HFH) or All-cause Mortality | 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). | The Modified Intent-to-Treat Population (mITT) includes all implanted subjects from the Open Label Arm and Former Treatment Arm. All primary and secondary effectiveness analyses are performed on the mITT. | Posted | | Number | 95% Confidence Interval | Events Per Patient Per 6 Months | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | Modified Intent-to-Treat (mITT) | Received standard of care heart failure management (i.e., Guideline Directed Medical Therapy) and Pulmonary Artery Pressure Guided Heart Failure Management (PAPGHFM) using the Cordella Heart Failure System (CHFS) with the PA pressure sensor. Made up of open label arm plus former treatment arm. | | OG001 | Former Control Arm | Received standard of care heart failure management (i.e., Guideline Directed Medical Therapy) using the Cordella Heart Failure System (CHFS) excluding the PA pressure sensor until the trial redesign. After trial redesign were crossed over to receive standard of care HF management using the Cordella HF system with the PA pressure sensor. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0000.1549(0.1225 to 0.1957)
- OG0010.2787(0.1798 to 0.4320)
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Poisson Regression | | <0.0001 | | | | | | | | | | | | | | Superiority | Poisson regression for comparison of incidence rate against performance goal (0.43) | |
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| Primary | Safety: Freedom From Device/System Related Complication | 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%. | The Intent-to-Treat Population (ITT) includes all enrolled subjects intended to receive the Cordella PA Sensor who entered the Cath Lab, including those in whom Implant Procedure was not attempted for whatever reason (e.g., Cordella PA Sensor Implant cannot be performed due to anatomical reasons) from the Open Label Arm and Former Treatment Arm. Patients in this population in whom the Cordella PA Sensor Implant was not attempted were followed through 30 days for safety purposes. | Posted | | Number | 95% Confidence Interval | Proportion of patients without a DSRC | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | Intent-to-Treat (ITT) | Received standard of care heart failure management (i.e., Guideline Directed Medical Therapy) and Pulmonary Artery Pressure Guided Heart Failure Management (PAPGHFM) using the Cordella Heart Failure System (CHFS) with the PA pressure sensor OR withdrew from trial and did not receive an implant. Cordellaâ„¢ 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.
- Cordella Sensor
- Cordella Delivery System
- myCordella Patient Reader
- Reader Dock
- Cordella Calibration Equipment (CalEQ)
- myCordella Hub
- Cordella Data Analysis Platform (CDAP)
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| Primary | Safety: Freedom From Pressure Sensor Failure | 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%. | The Intent-to-Treat Population (ITT) includes all enrolled subjects intended to receive the Cordella PA Sensor who entered the Cath Lab, including those in whom Implant Procedure was not attempted for whatever reason (e.g., Cordella PA Sensor Implant cannot be performed due to anatomical reasons) from the Open Label Arm and Former Treatment Arm. Patients in this population in whom the Cordella PA Sensor Implant was not attempted were followed through 30 days for safety purposes. | Posted | | Number | 95% Confidence Interval | Proportion of patients without a PSF | | 6 months | | | | ID | Title | Description |
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| OG000 | Intent-to-Treat (ITT) | Received standard of care heart failure management (i.e., Guideline Directed Medical Therapy) and Pulmonary Artery Pressure Guided Heart Failure Management (PAPGHFM) using the Cordella Heart Failure System (CHFS) with the PA pressure sensor OR withdrew from trial and did not receive an implant. Cordellaâ„¢ 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.
- Cordella Sensor
- Cordella Delivery System
- myCordella Patient Reader
- Reader Dock
- Cordella Calibration Equipment (CalEQ)
- myCordella Hub
- Cordella Data Analysis Platform (CDAP)
|
|
| Secondary | HF Hospitalizations | Number of HF Hospitalizations at 6 months post-implant compared to the number of HF Hospitalizations in the 6 months prior to implant | The Modified Intent-to-Treat Population (mITT) includes all implanted subjects from the Open Label Arm and Former Treatment Arm. All primary and secondary effectiveness analyses are performed on the mITT. | Posted | | Number | | events | | 6 Months prior to implant and 6 months post implant | | | | ID | Title | Description |
|---|
| OG000 | Modified Intent-to-Treat (mITT) | Received standard of care heart failure management (i.e., Guideline Directed Medical Therapy) and Pulmonary Artery Pressure Guided Heart Failure Management (PAPGHFM) using the Cordella Heart Failure System (CHFS) with the PA pressure sensor. Made up of open label arm plus former treatment arm. | | OG001 | Former Control Arm | Received standard of care heart failure management (i.e., Guideline Directed Medical Therapy) using the Cordella Heart Failure System (CHFS) excluding the PA pressure sensor until the trial redesign. After trial redesign were crossed over to receive standard of care HF management using the Cordella HF system with the PA pressure sensor. |
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| Secondary | HF Hospitalizations or Emergency Department/Hospital Outpatient IV Diuretic Visits. | 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. | The Modified Intent-to-Treat Population (mITT) includes all implanted subjects from the Open Label Armand Former Treatment Arm. All primary and secondary effectiveness analyses are performed on the mITT. | Posted | | Number | 95% Confidence Interval | Events Per Patient Per 6 Months | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | Modified Intent-to-Treat (mITT) | Received standard of care heart failure management (i.e., Guideline Directed Medical Therapy) and Pulmonary Artery Pressure Guided Heart Failure Management (PAPGHFM) using the Cordella Heart Failure System (CHFS) with the PA pressure sensor. Made up of open label arm plus former treatment arm. | | OG001 | Former Control Arm | Received standard of care heart failure management (i.e., Guideline Directed Medical Therapy) using the Cordella Heart Failure System (CHFS) excluding the PA pressure sensor until the trial redesign. After trial redesign were crossed over to receive standard of care HF management using the Cordella HF system with the PA pressure sensor. |
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| Secondary | Mortality | Cardiac and all-cause mortality | The Modified Intent-to-Treat Population (mITT) includes all implanted subjects from the Open Label Armand Former Treatment Arm. All primary and secondary effectiveness analyses are performed on the mITT. | Posted | | Count of Participants | | Participants | | 6 Months | | | | ID | Title | Description |
|---|
| OG000 | Modified Intent-to-Treat (mITT) | Received standard of care heart failure management (i.e., Guideline Directed Medical Therapy) and Pulmonary Artery Pressure Guided Heart Failure Management (PAPGHFM) using the Cordella Heart Failure System (CHFS) with the PA pressure sensor. Made up of open label arm plus former treatment arm. | | OG001 | Former Control Arm | Received standard of care heart failure management (i.e., Guideline Directed Medical Therapy) using the Cordella Heart Failure System (CHFS) excluding the PA pressure sensor until the trial redesign. After trial redesign were crossed over to receive standard of care HF management using the Cordella HF system with the PA pressure sensor. |
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| Secondary | IV Diuretic Visits | Intravenous (IV) diuretic visits | The Modified Intent-to-Treat Population (mITT) includes all implanted subjects from the Open Label Armand Former Treatment Arm. All primary and secondary effectiveness analyses are performed on the mITT. | Posted | | Number | | events | | 6 Months | | | | ID | Title | Description |
|---|
| OG000 | Modified Intent-to-Treat (mITT) | Received standard of care heart failure management (i.e., Guideline Directed Medical Therapy) and Pulmonary Artery Pressure Guided Heart Failure Management (PAPGHFM) using the Cordella Heart Failure System (CHFS) with the PA pressure sensor. Made up of open label arm plus former treatment arm. | | OG001 | Former Control Arm | Received standard of care heart failure management (i.e., Guideline Directed Medical Therapy) using the Cordella Heart Failure System (CHFS) excluding the PA pressure sensor until the trial redesign. After trial redesign were crossed over to receive standard of care HF management using the Cordella HF system with the PA pressure sensor. |
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| Secondary | Pulmonary Artery Pressure (PAP) | 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 | The Modified Intent-to-Treat Population (mITT) includes all implanted subjects from the Open Label Armand Former Treatment Arm. All primary and secondary effectiveness analyses are performed on the mITT. mPAP target was 20 mmHG, thus patients above 20 mmHG for mPAP were assigned to Above Target group and patients at or below 20 mmHG mPAP were assigned to the Within/Below Target group. | Posted | | Mean | Standard Deviation | mmHG of mPAP | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | Modified Intent-to-Treat | The Modified Intent-to-Treat Population (mITT) includes all implanted subjects from the Open Label Armand Former Treatment Arm. All primary and secondary effectiveness analyses are performed on the mITT. | | OG001 | Above Target mPAP at Baseline | mPAP target was 20 mmHG, thus patients above 20 mmHG for mPAP were assigned to Above Target group. | | OG002 | Within/BelowTarget mPAP at Baseline | mPAP target was 20 mmHG, thus patients at or below 20 mmHG mPAP were assigned to the Within/Below Target group. |
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| Secondary | Device Success | Proportion of device success as documented by ability of the System to successfully transmit PAP data transmit PAP data | The Modified Intent-to-Treat Population (mITT) includes all implanted subjects from the Open Label Armand Former Treatment Arm. All primary and secondary effectiveness analyses are performed on the mITT. | Posted | | Number | | Proportion of device readings successful | | 6 Months | | | | ID | Title | Description |
|---|
| OG000 | Modified Intent-to-Treat (mITT) | Received standard of care heart failure management (i.e., Guideline Directed Medical Therapy) and Pulmonary Artery Pressure Guided Heart Failure Management (PAPGHFM) using the Cordella Heart Failure System (CHFS) with the PA pressure sensor. Made up of open label arm plus former treatment arm. |
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| Secondary | Kansas City Cardiomyopathy Questionnaire (KCCQ) | 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. | All primary and secondary effectiveness analyses are performed on the Modified Intent-to-Treat Population (mITT). For this measure, only patients who completed the measure were included in the results reported, which is the reason for the smaller number of patients in these results than in the mITT population overall. | Posted | | Mean | Standard Deviation | points | | 6 Months | | | | ID | Title | Description |
|---|
| OG000 | Modified Intent-to-Treat (mITT) | Received standard of care heart failure management (i.e., Guideline Directed Medical Therapy) and Pulmonary Artery Pressure Guided Heart Failure Management (PAPGHFM) using the Cordella Heart Failure System (CHFS) with the PA pressure sensor. Made up of open label arm plus former treatment arm. | |
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| Secondary | NYHA | 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. | All primary and secondary effectiveness analyses are performed on the Modified Intent-to-Treat Population (mITT). For this measure, only patients who completed the measure were included in the results reported, which is the reason for the smaller number of patients in these results than in the mITT population overall. | Posted | | Count of Participants | | Participants | | 6 Months | | | | ID | Title | Description |
|---|
| OG000 | Modified Intent-to-Treat (mITT) | Received standard of care heart failure management (i.e., Guideline Directed Medical Therapy) and Pulmonary Artery Pressure Guided Heart Failure Management (PAPGHFM) using the Cordella Heart Failure System (CHFS) with the PA pressure sensor. Made up of open label arm plus former treatment arm. |
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| Secondary | 6-Minute Walk Test | 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. | The Modified Intent-to-Treat Population (mITT) includes all implanted subjects from the Open Label Armand Former Treatment Arm. All primary and secondary effectiveness analyses are performed on the mITT. For this measure, only patients who completed the measure were included in the results reported, which is the reason for the smaller number of participants in these results than in the mITT population overall. | Posted | | Mean | Standard Deviation | Meters Walked | | 6 Months | | | | ID | Title | Description |
|---|
| OG000 | Modified Intent-to-Treat (mITT) | Received standard of care heart failure management (i.e., Guideline Directed Medical Therapy) and Pulmonary Artery Pressure Guided Heart Failure Management (PAPGHFM) using the Cordella Heart Failure System (CHFS) with the PA pressure sensor. Made up of open label arm plus former treatment arm. | | OG001 |
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| Secondary | Number and Percent of Patients With Serious Adverse Events | Number and percent of patients with serious adverse events throughout the study (site-reported). | The Intent-to-Treat Population (ITT) includes all implanted subjects from the Open Label Arm and Former Treatment Arm. All safety analyses were performed on the ITT population. | Posted | | Count of Participants | | Participants | | 6 Months | | | | ID | Title | Description |
|---|
| OG000 | Intent-to-Treat (ITT) | Received standard of care heart failure management (i.e., Guideline Directed Medical Therapy) and Pulmonary Artery Pressure Guided Heart Failure Management (PAPGHFM) using the Cordella Heart Failure System (CHFS) with the PA pressure sensor OR withdrew from trial and did not receive an implant. Cordellaâ„¢ 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.
- Cordella Sensor
- Cordella Delivery System
- myCordella Patient Reader
- Reader Dock
- Cordella Calibration Equipment (CalEQ)
- myCordella Hub
- Cordella Data Analysis Platform (CDAP)
| | OG001 | Former Control Arm | Received standard of care heart failure management (i.e., Guideline Directed Medical Therapy) using the Cordella Heart Failure System (CHFS) excluding the PA pressure sensor until the trial redesign. After trial redesign were crossed over to receive standard of care HF management using the Cordella HF system with the PA pressure sensor. |
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| Secondary | Incidence of HF Hospitalizations or All-cause Mortality | Incidence of HF Hospitalizations or all-cause mortality at 12 months calculated from Poisson regression. | Participants who received Cordella PA sensor implant. | Posted | | Number | 95% Confidence Interval | Events Per Patient Per 12 Months | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | Modified Intent-to-Treat (mITT) | Received standard of care heart failure management (i.e., Guideline Directed Medical Therapy) and Pulmonary Artery Pressure Guided Heart Failure Management (PAPGHFM) using the Cordella Heart Failure System (CHFS) with the PA pressure sensor. Made up of open label arm plus former treatment arm. | | OG001 | Former Control Arm | Received standard of care heart failure management (i.e., Guideline Directed Medical Therapy) using the Cordella Heart Failure System (CHFS) excluding the PA pressure sensor until the trial redesign. After trial redesign were crossed over to receive standard of care HF management using the Cordella HF system with the PA pressure sensor. |
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| Secondary | N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) | 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. | All primary and secondary effectiveness analyses are performed on the Modified Intent-to-Treat Population (mITT). For this measure, only patients who completed the measure were included in the results reported, which is the reason for the smaller number of patients in these results than in the mITT population overall. | Posted | | Mean | Standard Deviation | pg/ml | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | Modified Intent-to-Treat (mITT) | Received standard of care heart failure management (i.e., Guideline Directed Medical Therapy) and Pulmonary Artery Pressure Guided Heart Failure Management (PAPGHFM) using the Cordella Heart Failure System (CHFS) with the PA pressure sensor. Made up of open label arm plus former treatment arm. | | OG001 | Former Control Arm | Received standard of care heart failure management (i.e., Guideline Directed Medical Therapy) using the Cordella Heart Failure System (CHFS) excluding the PA pressure sensor until the trial redesign. After trial redesign were crossed over to receive standard of care HF management using the Cordella HF system with the PA pressure sensor. |
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| Secondary | Days Alive and Out of Hospital (DAOH) | Days Alive and Out of Hospital (DAOH) during the 6 months after implant | The Modified Intent-to-Treat Population (mITT) includes all implanted subjects from the Open Label Armand Former Treatment Arm. All primary and secondary effectiveness analyses are performed on the mITT. | Posted | | Mean | Standard Deviation | days | | 6 Months | | | | ID | Title | Description |
|---|
| OG000 | Modified Intent-to-Treat (mITT) | Received standard of care heart failure management (i.e., Guideline Directed Medical Therapy) and Pulmonary Artery Pressure Guided Heart Failure Management (PAPGHFM) using the Cordella Heart Failure System (CHFS) with the PA pressure sensor. Made up of open label arm plus former treatment arm. | | OG001 | Former Control Arm | Received standard of care heart failure management (i.e., Guideline Directed Medical Therapy) using the Cordella Heart Failure System (CHFS) excluding the PA pressure sensor until the trial redesign. After trial redesign were crossed over to receive standard of care HF management using the Cordella HF system with the PA pressure sensor. |
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| Secondary | Number of Heart Failure Related Medication Changes | Number of patients (%) with heart failure related medication changes in the 6 months after implant | The Modified Intent-to-Treat Population (mITT) includes all implanted subjects from the Open Label Armand Former Treatment Arm. All primary and secondary effectiveness analyses are performed on the mITT. | Posted | | Count of Participants | | Participants | | 6 Months | | | | ID | Title | Description |
|---|
| OG000 | Modified Intent-to-Treat (mITT) | Received standard of care heart failure management (i.e., Guideline Directed Medical Therapy) and Pulmonary Artery Pressure Guided Heart Failure Management (PAPGHFM) using the Cordella Heart Failure System (CHFS) with the PA pressure sensor. Made up of open label arm plus former treatment arm. | | OG001 | Former Control Arm | Received standard of care heart failure management (i.e., Guideline Directed Medical Therapy) using the Cordella Heart Failure System (CHFS) excluding the PA pressure sensor until the trial redesign. After trial redesign were crossed over to receive standard of care HF management using the Cordella HF system with the PA pressure sensor. |
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| Secondary | Number of HF Hospitalization or All-cause Mortality | Number of HF Hospitalizations or all-cause mortality at 12 months | Participants who received the Cordella PA sensor implant. | Posted | | Number | | Events | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | Modified Intent-to-Treat (mITT) | Received standard of care heart failure management (i.e., Guideline Directed Medical Therapy) and Pulmonary Artery Pressure Guided Heart Failure Management (PAPGHFM) using the Cordella Heart Failure System (CHFS) with the PA pressure sensor. Made up of open label arm plus former treatment arm. | | OG001 | Former Control Arm | Received standard of care heart failure management (i.e., Guideline Directed Medical Therapy) using the Cordella Heart Failure System (CHFS) excluding the PA pressure sensor until the trial redesign. After trial redesign were crossed over to receive standard of care HF management using the Cordella HF system with the PA pressure sensor. |
| |
| Secondary | Number of HF Hospitalization, Emergency Department/Hospital Outpatient IV Diuretic Visits, All-cause Mortality | Number of combined outcome of:
- First and recurrent Heart Failure Hospitalizations
- Emergency Department / Hospital Outpatient IV diuretic visits all-cause mortality at 6 months, added together with equal weighting into a total number of events.
| The Modified Intent-to-Treat Population (mITT) includes all implanted subjects from the Open Label Armand Former Treatment Arm. All primary and secondary effectiveness analyses are performed on the mITT. | Posted | | Number | | events | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | Modified Intent-to-Treat (mITT) | Received standard of care heart failure management (i.e., Guideline Directed Medical Therapy) and Pulmonary Artery Pressure Guided Heart Failure Management (PAPGHFM) using the Cordella Heart Failure System (CHFS) with the PA pressure sensor. Made up of open label arm plus former treatment arm. | | OG001 | Former Control Arm | Received standard of care heart failure management (i.e., Guideline Directed Medical Therapy) using the Cordella Heart Failure System (CHFS) excluding the PA pressure sensor until the trial redesign. After trial redesign were crossed over to receive standard of care HF management using the Cordella HF system with the PA pressure sensor. | | OG002 |
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| Secondary | Number of HF Hospitalization, Emergency Department/Hospital Outpatient IV Diuretic Visits | Number of HF Hospitalization, Emergency Department/Hospital Outpatient IV diuretic visits at 6 months. | The Modified Intent-to-Treat Population (mITT) includes all implanted subjects from the Open Label Armand Former Treatment Arm. All primary and secondary effectiveness analyses are performed on the mITT. | Posted | | Number | | Events | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | Modified Intent-to-Treat (mITT) | Received standard of care heart failure management (i.e., Guideline Directed Medical Therapy) and Pulmonary Artery Pressure Guided Heart Failure Management (PAPGHFM) using the Cordella Heart Failure System (CHFS) with the PA pressure sensor. Made up of open label arm plus former treatment arm. | | OG001 | Former Control Arm | Received standard of care heart failure management (i.e., Guideline Directed Medical Therapy) using the Cordella Heart Failure System (CHFS) excluding the PA pressure sensor until the trial redesign. After trial redesign were crossed over to receive standard of care HF management using the Cordella HF system with the PA pressure sensor. | | OG002 | Former Treatment Arm | Received standard of care HF management using the Cordella Heart Failure System (CHFS) and Pulmonary Artery Pressure Guided Heart Failure Management (PAPGHFM) using the Cordella Heart Failure System (CHFS) with the PA pressure sensor before and after trial redesign. |
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| Secondary | Implant Procedure and Procedure Related Adverse Events and Serious Adverse Events | Frequency of implant procedure and procedure related adverse events and serious adverse events | The Intent-to-Treat Population (ITT) includes all implanted subjects from the Open Label Arm and Former Treatment Arm. All safety analyses were performed on the ITT population. | Posted | | Count of Participants | | Participants | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | Intent-to-Treat (ITT) | Received standard of care heart failure management (i.e., Guideline Directed Medical Therapy) and Pulmonary Artery Pressure Guided Heart Failure Management (PAPGHFM) using the Cordella Heart Failure System (CHFS) with the PA pressure sensor OR withdrew from trial and did not receive an implant. Cordellaâ„¢ 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.
- Cordella Sensor
- Cordella Delivery System
- myCordella Patient Reader
- Reader Dock
- Cordella Calibration Equipment (CalEQ)
- myCordella Hub
- Cordella Data Analysis Platform (CDAP)
|
| |