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Implantable Device
Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy (PAS Trial)
N/A
Recruiting
Research Sponsored by Impulse Dynamics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group
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%
Eligible Conditions
- Heart Failure
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
All-cause mortality
Incidence of procedure and device-related complications
Procedure related complications
Secondary study objectives
Cardiovascular hospitalizations
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Find a Location
Who is running the clinical trial?
Impulse DynamicsLead Sponsor
13 Previous Clinical Trials
3,197 Total Patients Enrolled
11 Trials studying Heart Failure
2,995 Patients Enrolled for Heart Failure
Raul Weiss, MDStudy DirectorMt. Sinai Miami
4 Previous Clinical Trials
1,419 Total Patients Enrolled
1 Trials studying Heart Failure
816 Patients Enrolled for Heart Failure
Rami Kahwash, MDStudy DirectorThe Ohio State University Wexner Medical Center