Trials / Completed
CompletedNCT03484780
VisONE Heart Failure Study: Pilot
VisONE Pilot Study of Chronic Asymptomatic Diaphragmatic Stimulation for Patients With Symptomatic Heart Failure, Reduced Ejection Fraction and Preserved Ventricular Synchrony
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- VisCardia Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The VisONE HF pilot is a feasibility pilot for evaluating the benefits and risks of chronically delivering Asymptomatic Diaphragmatic Stimulation in medical refractory heart failure patients using the VisONE™ implantable system for 12 months.
Detailed description
This 12 month study is intended to validate the early benefits observed with Asymptomatic Diaphragmatic Stimulation (ADS) as a primary form of heart failure therapy with low rates and severity of adverse effects. Medical refractory symptomatic heart failure patients with reduced ejection fraction and no evidence of arrhythmias or ventricular dysynchrony will undergo laparoscopic implantation of the VisONE™ implantable system comprised of a pulse generator and two leads, programmed to deliver cardiac-gaited diaphragmatic stimulation pulses at asymptomatic outputs. Patients will be followed in pre-specified durations of 1,3,6 and 12-months using a series of evaluations of hemodynamic, echocardiographic, heart failure status, diaphragmatic function, implanted system data and standard safety measures including adverse events, for comparison with their baseline values. The results are intended to be used for designing a subsequent larger study for performing statistical power calculations.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | VisONE ADS | VisONE stimulator and leads for delivering continual Synchronized Diaphragmatic Stimulation |
Timeline
- Start date
- 2018-07-25
- Primary completion
- 2019-12-12
- Completion
- 2019-12-12
- First posted
- 2018-04-02
- Last updated
- 2020-05-20
Locations
3 sites across 2 countries: Georgia, Ukraine
Source: ClinicalTrials.gov record NCT03484780. Inclusion in this directory is not an endorsement.