NYHA Class III Heart Failure
Conditions
Brief summary
The purpose of the trial is to evaluate the wireless monitoring of pulmonary artery pressure using the CardioMEMS HF Pressure Measurement System in adult subjects with NYHA Class III Heart Failure.
Detailed description
The trial is designed to demonstrate that the CardioMEMS Sensor can be positioned in the right or left pulmonary artery, and that Sensor pressure measurements correlate to standardized methods of intra-cardiac pressure measurements post-sensor implant and at the 60 day visit. Safety will be monitored by the occurrence of adverse events throughout the trial.
Interventions
DEVICECardioMEMS HF Pressure Measurement System
Implant sensor into the left or right pulmonary artery. Measure pulmonary artery pressure
Sponsors
CardioMEMS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is male or female, at least 18 years of age 2. Subjects of childbearing age who have a negative serum pregnancy test, and at screening have agreed to use a reliable mechanical or hormonal form of conception during the study. 3. Subject has a diagnosis of New York Heart Association (NYHA) Class III HF at screening and at baseline. 4. Subject is able and willing to provide written informed consent or the subject guardian is able and willing to provide informed consent. 5. Subject has life expectancy of 1-2 years.
Exclusion criteria
1. Subject has unstable medical condition or impairment other than a medical condition associated with HF which would significantly increase the subject's morbidity or mortality risk. 2. Subject is unable to tolerate a right heart catheterization. 3. Subject is planned to undergo a heart transplantation or cardiac surgery within 2 months after enrollment. 4. Subject has permanent indwelling central venous catheter. 5. Subject has history of myocardial infarction (MI), unstable angina, stroke, transient ischemic attack, or intractable arrhythmias within last 2 months. 6. Subject has history of congenital heart disease or prosthetic valve on right side. 7. Subject has unstable hypertension. 8. Subject has a known coagulability disease state. 9. Subject has a known hypersensitivity and/or allergy to aspirin and clopidogrel. 10. Subject has active lung infection or acute pulmonary decompensation. 11. Subject has elevated white blood cell count and signs of infection are evident. 12. Subject has chronic renal insufficiency as defined by serum creatinine of greater than or equal to 2 mg/dl or requirement for dialysis. 13. Subject who is pregnant or lactating or might become pregnant during the duration of the study. 14. Subject who is participating in another therapeutic interventional trial. 15. Subject has other medical, psychological, or social circumstances that may affect the ability to comply with the study requirements or increase risk to the subject.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary objective is to evaluate the wireless monitoring of pulmonary artery pressure using the CardioMEMS HF Pressure Measurement System in adult subjects with Class III Heart Failure. | after implant of the sensor and at 60 day visit | The trial will demonstrate that the CardioMEMS Sensor can be positioned in the right or left pulmonary artery, and the Sensor pulmonary artery pressure measurements correlate to standardized methods of intra-cardiac pressure measurements immediately after deployment of the sensor and at the 60 day follow-up visit. Safety is assessed by monitoring the occurrence of adverse events. |
Secondary
| Measure | Time frame |
|---|---|
| To demonstrate the capability of the CardioMEMS HF System to obtain the pressure measurement from the Sensor and transmit the pulmonary artery pressure data to a secure database. | after deployment of the sensor and at 60 days |
Countries
United States
Outcome results
None listed