NCT03970343

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 620 (estimated)
• Sponsor: Impulse Dynamics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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%

Detailed description

The Impulse Dynamics OPTIMIZER Smart Pre-Market Application (PMA) clinical data confirmed that CCM therapy delivered with the Optimizer meaningfully improved health outcomes in patients with NYHA class III heart failure symptoms and left ventricular ejection fraction of 25-45%. CCM has shown significant improvements in quality of life measures, with an average improvement of \>11 points in MLHWFQ incremental to the improvement of a randomized control group with no device. Six minute hall walk and functional class also showed improvements in the PMA data. The post-approval study (PAS) protocol has been designed to evaluate long term safety and efficacy of the OPTIMIZER Smart in a real-world setting.

Conditions

• Heart Failure

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-01-21
• Primary completion: 2028-07-01
• Completion: 2028-07-01
• First posted: 2019-05-31
• Last updated: 2025-11-20

Locations

90 sites across 1 country: United States

Regulatory

• FDA-regulated device study