Device Trial Participant Snapshot: Cordella Pulmonary Artery Sensor System (CorPASS)
Device Category: Cardiovascular
Summary:
What is this device used for?
This sensor system measures, records, and transmits pulmonary artery pressure (the pressure the heart uses to pump blood through the arteries of the lungs). This device is used for patients with class III heart failure, which is a serious form of poor pumping ability of the heart. Patients eligible for this device have noticeable limitations in their ability to perform physical activity and are on medical therapy. This device helps monitor and manage heart failure at home by transmitting important data to clinicians and allows them to modify a patient’s medical therapy.
How is the device used?
A doctor places this permanent blood pressure sensor into a class III heart failure patient’s pulmonary artery (a major artery of the heart). Once in place, a patient can obtain measurements by placing a Reader against their chest and running a mobile device app. This device therefore allows the patient, while at home, to wirelessly measure their heart’s function on demand. The app sends these results securely to a clinician for review to enable close monitoring of the patient’s heart condition.
What are the benefits of this device?
This device allows for at home, on-demand measurement of important pulmonary artery pressure information by patients and their providers. It also allows a doctor to make changes to medical treatment based on the sensors results.
What are the risks and potential harmful side effects of this device?
Risks include those both during and after device implantation. These include, but are not limited to, the device moving from where it was placed in the body, injury to the blood vessels or heart valves, bleeding, blood clots, and abnormal heart rate or rhythm. In the clinical studies, there was also a higher rate of coughing up blood in individuals using this device.
Demographics Snapshot:
Figure 1. Participant Demographics by Sex
Figure 2. Participant Demographics by Race
Figure 3. Participant Demographics by Ethnicity
Table 1: Participant Demographics
| Category | Average | Range |
|---|---|---|
| Age (years) | 63.5 | 51-76 |
| Number of Participants | Percentage (%) | |
| Sex | ||
| Male | 276 | 60.5% |
| Female | 180 | 39.5% |
| Race | ||
| American Indian or Alaskan Native | 2 | 0.4% |
| Asian | 7 | 1.5% |
| Black or African American | 84 | 18.4% |
| Native Hawaiian or Pacific Islander | 3 | 0.7% |
| White | 347 | 76.1% |
| Other | 4 | 0.9% |
| Unknown | 9 | 2% |
| Ethnicity | ||
| Hispanic or Latino | 20 | 4.4% |
| Non-Hispanic or Latino | 401 | 87.9% |
| Ethnicity not Reported | 13 | 2.9% |
| Unknown | 22 | 4.8% |
Who participated in the clinical trials studies?
Clinical studies were performed between January 2020 and September 2023 and included 456 patients with class III heart failure, across 77 investigational sites. For more information about the demographics of all participants, please see Table 1.
What did the trials evaluate?
The device was evaluated by looking at the ability of the sensor and system to reduce the rates of hospitalization and death in class III heart failure patients compared to the rates seen in other combined clinical trials.
Were there any differences in risks or how well the device worked in the clinical trials among different sexes, races, and age groups?
Based on available data, there were no differences noted in risks or benefits of the device by sex, race, or ethnicity. There was no analysis done by age. These findings should be interpreted with caution because the number of participants in each subgroup was small.
Summary for Clinical Audiences
Safety and effectiveness of this device was determined through a prospective, single arm, open label, multi-center clinical trial in NYHA functional class III heart failure patients with either preserved or reduced left ventricular ejection fraction. The study compared how often patients receiving the device needed to go to the hospital because of their heart failure getting worse or died for any reason with how often these events have been observed in a review of similar studies. The primary safety endpoint was lack of pressure sensor failure and device related adverse events at 6 months. The primary effectiveness endpoint was the 6-month incidence of heart failure related hospitalization or all-cause mortality. Both primary endpoints were met. A post approval study will collect additional evidence of continued safety and effectiveness outcomes under commercial use, which is expected to include a more heterogeneous patient population.