Heart Failure With Reduced Ejection Fraction, HFrEF Clinical Trial
Official title:
VisONE Pilot Study of Chronic Asymptomatic Diaphragmatic Stimulation for Patients With Symptomatic Heart Failure, Reduced Ejection Fraction and Preserved Ventricular Synchrony
| Verified date | May 2020 |
| Source | VisCardia Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 15 |
| Est. completion date | December 12, 2019 |
| Est. primary completion date | December 12, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria - NYHA class II/III medical refractory despite guideline indicated heart failure medications - Sinus rhythm with <10% ectopy - EF = 35% - NT-proBNP > 500 (250 if on loop diuretics) Exclusion Criteria - 6MHW >500 m or < 200 m - Resting HR > 140 bpm - SBP <80 mmHg or > 170 mmHg - Serum creatine > 2.5 mg/dL - Ventricular dyssynchrony by ECG with QRS = 140ms - Unstable angina, AMI, CABG, PTCA, CVA/TIA, persistent AF, NSVT, sustained VT or VF, or DCCV within 3 months - Intermittent inotropic drug treatment - Existing pacemaker or indications for a pacemaker - Severe primary pulmonary disease including pulmonary arterial hypertension or severe COPD, or other respiratory or lung diseases where FEV < 50% or any condition with severe diaphragmatic dysfunction - Previous open laparotomy within 1 year or contraindications to laparoscopy, as determined by implanting physician - Known or active intra-abdominal infections, or known intra-abdominal pathology - Previous thoracic or abdominal organ transplant, transplant waiting list - Pregnancy |
| Country | Name | City | State |
|---|---|---|---|
| Georgia | Tbilisi Heart and Vascular Clinic | Tbilisi | |
| Ukraine | Kyiv City Heart Center | Kiev | |
| Ukraine | Amosov National Institute of Cardiovascular Surgery | Kyiv |
| Lead Sponsor | Collaborator |
|---|---|
| VisCardia Inc. | Clinical Accelerator Ltd., Stiftung für Herz-und Kreislaufkrankheiten, University Hospital, Zürich, University of Glasgow |
Georgia, Ukraine,
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, crossove — View Citation
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 Coll
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 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Clinical composite of heart failure and cardiac function | The following outcomes will be analyzed determine the potential therapeutic impact on clinical heart failure management NT Pro-BNP blood levels to assess heart failure status Improvements to cardiac output, stroke volume or left ventricular filling Improvements to left ventricular volumes or ejection fraction Improvements to heart failure status, 6 minute hall walk, or assessment by heart failure questionnaire |
after 0, 1, 3, 6 and 12 months of therapy | |
| Primary | 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 Excessive procedural or implanted system morbidity Procedural or implanted system events resulting in unscheduled patient hospitalizations and surgical intervention Incidences resulting in physician choice to permanently discontinue therapy |
after 3 months of therapy | |
| Secondary | 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 Procedural or implanted system events resulting in adverse patient symptoms Degradation of respiratory function by spirometer measures associated with procedure or implanted system Adverse events due to procedural or implanted system complications correctable by non re-operative means including system reprogramming or other readjustments |
after 3 and 12 months of therapy | |
| Secondary | 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 Excessive procedural or implanted system morbidity Procedural or implanted system events resulting in unscheduled patient hospitalizations and surgical intervention Incidences resulting in physician choice to permanently discontinue therapy |
after 12 months of therapy |