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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03484780
Registration number
NCT03484780
Ethics application status
Date submitted
16/03/2018
Date registered
2/04/2018
Date last updated
20/05/2020
Titles & IDs
Public title
VisONE Heart Failure Study: Pilot
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Scientific title
VisONE Pilot Study of Chronic Asymptomatic Diaphragmatic Stimulation for Patients With Symptomatic Heart Failure, Reduced Ejection Fraction and Preserved Ventricular Synchrony
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Secondary ID [1]
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VisCardia H01_17
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Failure With Reduced Ejection Fraction, HFrEF
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - VisONE ADS
Experimental: VisONE ADS - Patients implanted with a VisONE stimulator and leads for receiving continual Synchronized Diaphragmatic Stimulation
Treatment: Devices: VisONE ADS
VisONE stimulator and leads for delivering continual Synchronized Diaphragmatic Stimulation
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Freedom from serious complications or adverse events during procedural recovery and acute therapy
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Assessment method [1]
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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
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Timepoint [1]
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after 3 months of therapy
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Secondary outcome [1]
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Freedom from complications or adverse events during chronic therapy
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Assessment method [1]
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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
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Timepoint [1]
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after 3 and 12 months of therapy
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Secondary outcome [2]
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Freedom from serious complications or adverse events during chronic therapy
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Assessment method [2]
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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
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Timepoint [2]
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after 12 months of therapy
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Eligibility
Key inclusion criteria
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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/07/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/12/2019
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Sample size
Target
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Accrual to date
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Final
15
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Georgia
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State/province [1]
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Tbilisi
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Country [2]
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Ukraine
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State/province [2]
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Kiev
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Country [3]
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Ukraine
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State/province [3]
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Kyiv
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
VisCardia Inc.
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Clinical Accelerator Ltd.
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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University of Glasgow
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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University Hospital, Zürich
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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Stiftung für Herz-und Kreislaufkrankheiten
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Address [4]
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Country [4]
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Ethics approval
Ethics application status
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Summary
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 VisONEā¢ implantable system for 12 months.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03484780
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Vitaly Demyanchuk, M.D. Ph.D.
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Address
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Kyiv City Heart Center
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03484780
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