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This is a prospective, multi-center, open-label, single-arm feasibility trial to assess device safety and efficacy of the Cordella™ Heart Failure System in 10 NYHA Class III heart failure patients who will receive the Cordella™ Sensor implant.
The objectives of this study are to establish that the Cordella™ Sensor can be safely delivered, deployed, and remain stable within the target pulmonary artery (PA) segment through 30 days post-implant as well as to measure the accuracy of Cordella™ Sensor PA pressure measurements compared with fluid-filled catheter PA pressure measurements obtained by standard right heart catheterization (RHC) at 90 days post implant. Safety measures will include the frequency and rates of adverse events, both overall and for each specific event, which will be collected throughout the study. Subjects will remain in this trial for 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cordella™ Heart Failure System | Experimental | Cordella™ Heart Failure System and implant of Cordella™ Pulmonary Artery Sensor System (CorPASS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cordella™ Heart Failure System | Device | The Cordella™ Heart Failure System collects, records, and transmits physiologic data and communications from the patient at home to clinicians for assessment, patient communication, and patient-centered heart failure management. The system consists of the following components:
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Freedom form Adverse events | Freedom from adverse events associated with use of the Cordella™ HF System | 30 days |
| Efficacy: Accuracy | Accuracy of Cordella™ Sensor PA pressure measurements, compared to standard-of-care fluid-filled catheter PA pressure measurements obtained by standard Right Heart Catheter | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Adverse Events | Frequency of adverse events throughout the study | 30 days and 2 years |
| Device/system-related complications | Device/system-related complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Sauerland | Endotronix, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost Limburg | Genk | 3600 | Belgium | |||
| Galway University Hospital |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| 30 days and 2 years |
| Pressure sensor failure rate | Pressure sensor failure rate throughout the study | 30 days and 2 years |
| Accuracy of Cordella™ sensor pressure measurements | Accuracy of Cordella™ Sensor PA pressure measurements compared with echo pulmonary artery pressure (PAP) measurements | 2 years |
| Percentage of device success | Percentage of device success as documented by ability of the System to successfully transmit collected data to a secure database | 90 days |
| Change in Pulmonary Artery (PA) pressure | Change in PA pressure pre- and post-implant | 90 days |
| Heart Failure (HF) Hospitalizations | Frequency of HF hospitalizations, HF treatments in a hospital day-care setting, or urgent outpatient clinic HF visits. | 90 days |
| Quality of Life measured by Kansas City Cardiomyopathy Questionnaire | Quality of Life measured by KCCQ at 90 days and 2 years post implant procedure | 90 days and 2 years |
| Quality of Life measured by EuroQOL EQ-5D-5L | Quality of Life measured by EuroQOL EQ-5D-5L at 90 days and 2 years post implant procedure | 90 days and 2 years |
| Adherence to regular myCordella™ Peripherals measurements | Adherence to regular myCordella™ Peripherals measurements | 90 days and 2 years |
| Galway |
| H91 YR71 |
| Ireland |