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

NCT03970343 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 620

Last updated 2025-11-20

No results posted yet for this study

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%

Conditions

Interventions

DEVICE

OPTIMIZER Smart System

Eligible subjects will receive the OPTIMIZER Smart, which is comprised of three major components: 1. Optimizer Smart or Optimizer Smart Mini 2. Vesta Charger or Guardio Charger 3. Two commercially available intravascular leads

Sponsors & Collaborators

  • Impulse Dynamics

    lead INDUSTRY

Principal Investigators

  • Rami Kahwash, MD · Ohio State University

  • Raul Weiss, MD · Mt. Sinai Miami

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-21
Primary Completion
2028-07-31
Completion
2028-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03970343 on ClinicalTrials.gov