CardioMEMS HF System Post Approval Study (NCT02279888) | Clinical Trial Compass
CompletedNot Applicable
CardioMEMS HF System Post Approval Study
United States1,214 participantsStarted 2015-01
Plain-language summary
The purpose of the CardioMEMS HF System Post Approval Study (PAS) is to evaluate the use of the CardioMEMS HF System in patients with NYHA class III heart failure in a commercial setting.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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
* BMI ≤ 35. 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)
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Freedom From Device and/or System Related Complication (DSRC)