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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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:
Diabetic Macular Oedema 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

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
Not applicable
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)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
VisCardia Inc.
Address
Country

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/study/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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03484780