Clinical Trial

Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy

Study acronym: PAS
Active, Not Recruiting
View on ClinicalTrials.gov →
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%
Protocol Amendment History 71 amendments
This ClinicalTrials.gov record has been amended 71 times since 2019-05-30; most recent amendment 2025-11-18.
Status change: Recruiting → Active, Not Recruiting 2025-11-18
Status change: Not Yet Recruiting → Recruiting 2020-02-19
Trial Details
NCT Number NCT03970343
Lead Sponsor Impulse Dynamics
Conditions Heart Failure
Enrollment 620 participants
Start Date 2020-01-21
Primary Completion 2028-07 (estimated)
Study Completion 2028-07 (estimated)
Updated on ClinicalTrials.gov 2025-11-20