A Prospective, Multi-center, Non-randomized, Single Arm Open Label Study of 620 Subjects Receiving the OPTIMIZER Smart With CCM Therapy as Standard of Care
The post-approval study (PAS) protocol has been designed to evaluate long term safety and efficacy of the OPTIMIZER Smart in a real-world setting.
- Patient or legally authorized representative 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)
- 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 heart failure therapies with stable doses for at least 1 month