Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Clinical Accelerator | INDUSTRY |
| University of Glasgow | OTHER |
| University Hospital, Zürich | OTHER |
| Stiftung für Herz-und Kreislaufkrankheiten |
Not provided
Not provided
Not provided
Not provided
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 VisONEâ„¢ implantable system for 12 months.
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 VisONEâ„¢ 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VisONE ADS | Experimental | Patients implanted with a VisONE stimulator and leads for receiving continual Synchronized Diaphragmatic Stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VisONE ADS | Device | VisONE stimulator and leads for delivering continual Synchronized Diaphragmatic Stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from serious complications or adverse events during procedural recovery and acute therapy | The following serious complications and adverse events will be analyzed for their rate and severity and compared to other implantable device systems
| after 3 months of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from complications or adverse events during chronic therapy | The following adverse events will be analyzed for their rate and severity and compared to other implantable device systems
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical composite of heart failure and cardiac function | The following outcomes will be analyzed determine the potential therapeutic impact on clinical heart failure management
|
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vitaly Demyanchuk, M.D. Ph.D. | Kyiv City Heart Center | Principal Investigator |
| Rudenko Vladimirovich, M.D. | Amosov National Institute of Cardiovascular Surgery | Principal Investigator |
| Tamaz Shaburishvil, M.D. | Tbilisi Heart and Vascular Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tbilisi Heart and Vascular Clinic | Tbilisi | 0159 | Georgia | |||
| Kyiv City Heart Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24464736 | Result | Beeler R, Schoenenberger AW, Bauer P, Kobza R, Bergner M, Mueller X, Schlaepfer R, Zuber M, Erne S, Erne P. Improvement of cardiac function with device-based diaphragmatic stimulation in chronic heart failure patients: the randomized, open-label, crossover Epiphrenic II Pilot Trial. Eur J Heart Fail. 2014 Mar;16(3):342-9. doi: 10.1002/ejhf.20. Epub 2013 Dec 6. | |
| 19168496 |
| Label | URL |
|---|---|
| Proof of concept therapeutic feasibility study of chronic ADS in post CABG heart failure patients | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| UNKNOWN |
Patients implanted with the VisONE implantable system for delivering chronic Asymptomatic Diaphragmatic Stimulation (ADS).
Not provided
Not provided
Independent data review and analysis by the University of Glasgow Department of Biostatistics
Not provided
| after 3 and 12 months of therapy |
| Freedom from serious complications or adverse events during chronic therapy | The following serious complications and adverse events will be analyzed for their rate and severity and compared to other implantable device systems
| after 12 months of therapy |
| after 0, 1, 3, 6 and 12 months of therapy |
| Kiev |
| Ukraine |
| Amosov National Institute of Cardiovascular Surgery | Kyiv | Ukraine |
| Roos M, Kobza R, Jamshidi P, Bauer P, Resink T, Schlaepfer R, Stulz P, Zuber M, Erne P. Improved cardiac performance through pacing-induced diaphragmatic stimulation: a novel electrophysiological approach in heart failure management? Europace. 2009 Feb;11(2):191-9. doi: 10.1093/europace/eun377. |
| Result | Jorbenadze A, Shaburishvili N, Mirro M, Zuber M, Erne P, Shaburishvili T. First-In-Human Visone Heart Failure Study: Asymptomatic Diaphragmatic Stimulation For Chronic Heart Failure With Reduced Ejection Fraction: Case Report. Journal of the American College of Cardiology. 2020;75(11) Supplement 1 |