Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy (NCT03970343) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy
United States620 participantsStarted 2020-01-21
Plain-language summary
The OPTIMIZER Smart Post-Approval Study is a prospective, multi-center, non-randomized, single arm open label study of 620 subjects receiving an OPTIMIZER implant as standard of care. Patients to be included will have NYHA functional class III symptoms and a left ventricular ejection fraction of 25-45%
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
. Patient provides written authorization and/or consent per institution and geographical requirements
. Male or non-pregnant female, aged 18 or older
. Left ventricular ejection fraction of 25-45% (inclusive, per site assessment)
. NYHA Class III heart failure symptoms
. Stated willingness to comply with all study procedures and availability for the duration of the study
. Patient has been treated with guideline-directed medical therapy
Exclusion criteria
. Primary heart failure due to uncorrected mitral valve disease, or mitral valve repair or clip within 90 days of implant
. IV inotropes, hemofiltration, or any form of positive inotropic support within 30 days prior to implant
. Myocardial infarction within 90 days prior to implant
. Undergone a CABG procedure within 90 days or a PTCA procedure within 30 days of implant
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
Incidence of procedure and device-related complications
. Prior heart transplant or ventricular assist device
. Mechanical tricuspid valve
. Receiving cardiac resynchronization therapy (CRT) or has a Class I indication for CRT implantation according to the ACCF/AHA/HRS guidelines for device-based therapy
. Participating in a cardiac investigational study at the same time