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Implantable Device

Treatment for Heart Failure (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

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%

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
All-cause mortality
Incidence of procedure and device-related complications
Procedure related complications
Secondary outcome measures
Cardiovascular hospitalizations

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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
~144 spots leftby Mar 2026
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