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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03484780




Registration number
NCT03484780
Ethics application status
Date submitted
1/03/2018
Date registered
25/03/2018
Date last updated
25/03/2018

Titles & IDs
Public title
VisONE Heart Failure Study: Pilot
Scientific title
VisONE Pilot Study of Chronic Asymptomatic Diaphragmatic Stimulation for Patients With Symptomatic Heart Failure, Reduced Ejection Fraction and Preserved Ventricular Synchrony
Secondary ID [1] 0 0
VisCardia H01_17
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - VisONE ADS

Experimental: VisONE ADS - Patients implanted with a VisONE stimulator and leads for receiving continual Asymptomatic Diaphragmatic Stimulation


Treatment: Devices: VisONE ADS
VisONE stimulator and leads for delivering continual Asymptomatic Diaphragmatic Stimulation

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
after 3 months of therapy
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
after 3 and 12 months of therapy
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
after 12 months of therapy

Eligibility
Key inclusion criteria
Inclusion Criteria

- NYHA class III medical refractory despite guideline indicated heart failure
medications

- Sinus rhythm with no prior arrhythmias

- EF ≤ 35%
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

- Ventricular dyssynchrony by ECG with QRS ≥ 140ms

- Unstable angina, AMI, CABG, PTCA, CVA/TIA within 3 months

- Intermittent inotropic drug treatment

- Prior arrhythmias or present during screening (bradycardia, NSVT, sustained VT or VF,
persistent AF), pacemakers 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 or contraindications to laparoscopy, as determined by
implanting physician

- Known or active intra-abdominal infections, or known intra-abdominal pathology

- Transplant waiting list or other known scheduled procedures

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Ukraine
State/province [1] 0 0
Kiev

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
VisCardia Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Clinical Accelerator Ltd.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Glasgow
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University Hospital, Zürich
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Stiftung für Herz-und Kreislaufkrankheiten
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a 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.
Trial website
https://clinicaltrials.gov/show/NCT03484780
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Vitaly Demyanchuk, M.D. Ph.D.
Address 0 0
Kyiv City Heart Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Peter Bauer, Ph.D.
Address 0 0
Country 0 0
Phone 0 0
(503) 806 6169
Fax 0 0
Email 0 0
BauerP@Viscardia.com
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable