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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
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 With Reduced Ejection Fraction, HFrEF 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 Synchronized Diaphragmatic Stimulation


Treatment: Devices: VisONE ADS
VisONE stimulator and leads for delivering continual Synchronized 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
Timepoint [1] 0 0
after 3 months of therapy
Secondary outcome [1] 0 0
Freedom from complications or adverse events during chronic therapy
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
Timepoint [2] 0 0
after 12 months of therapy

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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/12/2019
Sample size
Target
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Georgia
State/province [1] 0 0
Tbilisi
Country [2] 0 0
Ukraine
State/province [2] 0 0
Kiev
Country [3] 0 0
Ukraine
State/province [3] 0 0
Kyiv

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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03484780
Trial related presentations / publications
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

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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries