This is a prospective, multi-center, randomized, single-blind clinical trial conducted in the United States (US). The objective of the study is to evaluate the safety and efficacy of the HF Pressure Measurement System in reducing heart failure (HF) related hospitalizations in a subset of subjects suffering from HF.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
550
A pressure sensor is intended to be implanted into the pulmonary artery at the time of Swan-Ganz catheterization.
CardioMEMS Investigational Sites
Nationwide, Georgia, United States
Rate of Heart Failure Related (HFR) Hospitalizations
Time frame: 6 months
Freedom From a Device/System-related Complication (DSRC).
A DSRC is an adverse event that is, or is possibly, related to the HF Pressure Measurement System and at least one the following: * is treated with invasive means (other than intramuscular medication or a right heart catheterization with a Swan-Ganz measurement which is used for diagnostic purposes) * results in the death of the subject * results in the explant of the device
Time frame: 6 months
Freedom From Pressure Sensor Failure
A pressure sensor failure occurs when the sensor malfunctions to the point that no readings can be obtained from it after all attempts are exhausted including troubleshooting the system to rule out any problems with the electronic components.
Time frame: 6 months
Change From Baseline in Pulmonary Artery Mean Pressure
Change from baseline in pulmonary artery mean pressure was calculated using an area under the curve (AUC) methodology. All patients were instructed to take daily home readings for 180 days. By patient, a baseline average for the first 7 days of home readings was calculated. The difference between baseline and each daily reading was then determined and a corresponding daily AUC value was calculated. Finally, all daily AUC values were summed over the entire 180 day period resulting in a total AUC per patient. These data were aggregated for each randomization group and then compared. The unit of measure is mmHg x Days.
Time frame: 6 months
Proportion of Patients Hospitalized for Heart Failure
Time frame: 6 months
Days Alive Outside of the Hospital
Time frame: 6 months
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Quality of Life - Minnesota Living With Heart Failure Questionnaire (MLHFQ)
THe MLHFQ is patient self-assessment of how heart failure affects his or her daily life. To measure the effects of symptoms, functional limitations, psychological distress on an individual's quality of life, the MLHFQ questionnaire asks each person to indicate using a 6-point, zero to five, Likert scale how much each of 21 facets prevented them from living as they desired. Total scores are provided as sums. The total score scale range is 0 - 105. A lower total score is indicative of better quality of life.
Time frame: 6 months