Status:
COMPLETED
VisONE Heart Failure Study: Pilot
Lead Sponsor:
VisCardia Inc.
Collaborating Sponsors:
Clinical Accelerator
University of Glasgow
Conditions:
Heart Failure With Reduced Ejection Fraction, HFrEF
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
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 adve...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2019
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03484780
Start Date
July 25 2018
End Date
December 12 2019
Last Update
May 20 2020
Active Locations (3)
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1
Tbilisi Heart and Vascular Clinic
Tbilisi, Georgia, 0159
2
Kyiv City Heart Center
Kiev, Ukraine
3
Amosov National Institute of Cardiovascular Surgery
Kyiv, Ukraine