Clinical trial

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

NCT03970343 · Impulse Dynamics, Industry · Active, not recruiting

Key facts

NCT number NCT03970343
Title Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy
Official title 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
Acronym PAS
Lead sponsor Impulse Dynamics, Industry
Status Active, not recruiting
Study type Observational [Patient Registry]
Conditions Heart Failure
Intervention type Device
Interventions OPTIMIZER Smart System
Enrollment 620
Start date Jan 21, 2020
Primary completion Jul 1, 2028
Completion Jul 1, 2028
First posted May 31, 2019
Last update posted Nov 20, 2025
Countries United States

At a glance

  • 100–999 Study sites
  • No Results posted
  • 10–99 FDA inspections linked to this trial
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date:

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