Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT02729922 |
| Other study ID # |
824716 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 2016 |
| Est. completion date |
June 2025 |
Study information
| Verified date |
August 2023 |
| Source |
University of Pennsylvania |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
CardioMEMS is an implantable wireless hemodynamic monitoring system which can transmit the
pulmonary artery pressure. This device is FDA approved to be used as a diagnostic tool to
help management of selected heart failure patients. Heart failure patients with NYHA class
III heart failure, irrespective of the left ventricular ejection fraction, and a previous
hospital admission for heart failure in the past 12 months, without stage IV or V chronic
kidney disease are candidates to receive a CardioMEMS device. Our goal is to create a
registry of all patients that receive a CardioMEMS device and monitor outcomes, primarily
heart failure hospitalizations, heart failure related quality of life and re-admissions.
Description:
Background Clinical trials with CardioMEMS were done and the device is now FDA approved for
use in heart failure patients with NYHA class III heart failure for at least three months,
irrespective of the left ventricular ejection fraction, with a previous hospitalization for
heart failure in the last 12 months. Patients with chronic kidney disease stage IV or V are
excluded.
Briefly, the CHAMPION Trial, which was published in the Lancet (Lancet 2011; 377: 658-66),
enrolled patients in 64 centers in the USA and were randomly assigned by the use of a
centralized electronic system to management with CardioMEMS or a control group. The patients
were followed for six months. The treatment group used daily measures of pulmonary artery
pressures in addition to standard of care versus standard of care alone in the control group.
The protocol for the treatment group was to lower the pulmonary artery pressures when
elevated, using neurohormonal, diuretic, or vasodilator drugs. The control group continued to
have drug changes in response to patients' clinical signs and symptoms rather than the
pulmonary artery pressure. All patients were on optimum drug and device therapies at the time
of sensor implantation in accordance to the ACC and AHA guidelines. At six months the
treatment group had a 37% reduction in heart failure related hospitalizations, patients with
more days alive outside the hospital, and better quality of life compared to the control
group.
A follow up study was published in the Lancet (Lancet 2016; 387:453-461) which examined the
extended efficacy of this strategy over 18 months looking at the clinical effect of open
access to pressure information and monitored the original treatment group for an additional
13 months. After pulmonary artery pressure information became available to guide therapy
during open access (the devices in the control group were activated and followed for the 13
months after the initial six months), rates of admissions to hospital for heart failure in
the former control group were reduced by 48% compared with rates of admissions in the control
group during randomized access (initial six months).
These studies show that both short term and long term management of NYHA Class III heart
failure based on home transmission of pulmonary artery pressure with an implanted pressure
sensor has significant short-term and long-term benefit in lowering hospital admission rates
for heart failure.
Patients aged 18 years or older with moderate NYHA functional class III heart failure for at
least 3 months, irrespective of left ventricular ejection fraction or cause, and a
hospitalization for heart failure within the past 12 months are eligible for a CardioMEMS
device. If the patient is thought to be a good clinical candidate, with difficult to manage
fluid status, the patient and their Heart Failure Cardiologist will discuss the option of
having a CardioMEMS device implanted for standard of care treatment. If the device is
implanted, the patient will be asked to be enrolled in the registry. The patient will have
normal clinical follow up and clinically standard interrogations. The device interrogations
will be sent daily from the patient and reviewed once a week unless the patient calls with
symptoms or weight gain in which it will be reviewed at that time. If changes in medications
are made, the patient's device will be interrogated daily for 3 subsequent days and then
return to the baseline weekly interrogation. The data obtained from the interrogation is the
pulmonary artery pressure. There are no research interventions outside of normal standard
clinical care. All of the clinically collected data will be recorded in the Penn CardioMEMS
registry.
Patients will be followed up in clinic one month after implant, then 3 months and then as
determined by their Heart Failure Cardiologist as part of usual clinical care. A quality of
life assessment will be done at each clinic appointment for the first year (Minnesota Living
with Heart Failure questionnaire).
Adverse events will be recorded as they occur. There are device-related or system-related
complications such as bleeding complications or pressure-sensor failures defined as the
inability to obtain recordings. Of note, during the clinical trials there were no
pressure-sensor failures.
The data will be collected from the clinical electronic medical record and administrative
data sets at the University of Pennsylvania.
Standard statistical methods will be used. Statistical analysis will be done with Wilcoxon
rank sum test and student's t test with alpha=0.05. Patient survival rates will be analyzed
by Kaplan-Meier method and the log-rank test.
