CardioMEMSTM HF System Post Approval Study
Description
Detailed Description
RATIONALE: Heart failure is a major cause of morbidity and mortality. CardioMEMS HF System is an FDA approved implantable device that wirelessly measures and monitors pulmonary arterial pressure and heart rate. The CHAMPION trial demonstrated that management of heart failure using pulmonary artery pressure information obtained with the CardioMEMS HF System, in addition to traditional signs and symptoms, reduced HF hospitalizations.
INTERVENTION: Patients will be scheduled for follow-up visits at 1 month and every 6 months for 2 years. Following sensor implant and hospital discharge, subjects will take PA pressure measurements on a daily basis, or as directed by the investigator. These measurements will be automatically transmitted to the secure Patient database (CardioMEMS HF website).
OBJECTIVES: The objective of this study is to confirm the post-market safety and effectiveness of the CardioMEMS HF System to premarket.
STUDY POPULATION: Twelve hundred subjects will be enrolled with at least 35% of the enrolled patients being women (420 women out of 1200). Enrollment will be limited to 15% of the total study population at any one site.
STUDY METHODOLOGY: This is a prospective, multi-center, open-label trial conducted in the United States (US). All subjects who sign the informed consent form and satisfy the inclusion/exclusion criteria will be enrolled into the CardioMEMS HF System PAS and will be scheduled for follow-up visits at 1 month and every 6 months for 2 years. Following sensor implant and hospital discharge, subjects will take PA pressure measurements on a daily basis, or as directed by the investigator. These measurements will be automatically transmitted to the secure Patient database (CardioMEMS HF website).
STUDY ENDPOINTS:Primary safety endpoints will be evaluated at 2 years: 1) freedom from device/system related complications and 2) freedom from pressure sensor failure.
STATISTICS: The primary safety hypotheses are that the device / system-related complication-free proportion of subjects will be at least 80% at 24 months (OPC used in the CHAMPION trial) and that the pressure sensor failure-free proportion of subjects will be at least 90% at 24 months (OPC used in the CHAMPION trial). Plotting and analysis of safety endpoints will also be displayed using Kaplan-Meier methods. All safety analyses will be performed on the safety population.
Phase
N/AInclusion and Exclusion Criteria
- - Diagnosis of NYHA class III heart failure - At least 1 heart failure hospitalization within previous 12 months - Patients with reduced LVEF heart failure should be receiving a beta blocker for 3 months and an ACE-I or ARB for one month unless in the investigator's opinion, the patient is intolerant to beta blockers, ACE-I or ARB
- Patients with BMI >35 will require their chest circumference to be measured at the axillary level. If > 65 inches the patient will not be eligible for the study. - Pulmonary artery branch diameter ≥ 7mm - (implant target artery - assessed during the right heart catheterization)
- Active infection
- History of recurrent (> 1) pulmonary embolism or deep vein thrombosis
- Inability to tolerate a right heart catheterization
- A major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke, etc.) within previous 2 months
- Cardiac resynchronization device (CRT) implanted within previous 3 months
- Glomerular Filtration Rate (GFR) < 25 ml/min (obtained within 2 weeks of implant) who are non-responsive to diuretic therapy or who are on chronic renal dialysis
- Congenital heart disease or mechanical right heart valve
- Likely to undergo heart transplantation or VAD within the next 6 months
- Known coagulation disorders
- Hypersensitivity or allergy to aspirin, and/or clopidogrel
Sites
Please contact Christine Tam to learn more about where you can participate in this trial. Please use the contact form on the right side.
Presentado por
SC CTSI