Trials / Completed
CompletedNCT03339310
Evaluation of the Safety and Efficacy of the 2-lead OPTIMIZER® Smart System
FIX-HF-5C2: Evaluation of the Safety and Efficacy of the 2-lead OPTIMIZER® Smart System in Subjects With Moderate-to-Severe Heart Failure With Ejection Fraction Between 25% and 45%
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Impulse Dynamics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter, prospective, single-arm study of the Optimizer Smart System with 2-leads
Detailed description
This is a multicenter, prospective, single-arm treatment only confirmatory study of the 2-lead configuration of the Optimizer Smart System.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Optimizer Smart System with 2-leads | The Optimizer Smart System with 2-leads delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Implanted subjects receive five non-contiguous one-hour periods of CCM signals per day. |
Timeline
- Start date
- 2017-10-23
- Primary completion
- 2019-10-30
- Completion
- 2019-10-30
- First posted
- 2017-11-13
- Last updated
- 2020-01-14
Locations
10 sites across 2 countries: United States, Germany
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03339310. Inclusion in this directory is not an endorsement.