Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000758606
Ethics application status
Approved
Date submitted
26/10/2005
Date registered
18/11/2005
Date last updated
18/11/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
CardioFit(TM) for heart Failure
Scientific title
A non randomized trial to evaluate the safety and efficacy of the CardioFit â¿¢ implantable neurostimulator for the treatment of patients diagnosed with NYHA Class II-IV heart failure disease to improve cardiac haemodynamic makers such as left ventricular ejection fraction, stroke volume and prevent the negative left ventricular remodeling seen in patients with a congestive cardiomyopathy.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
NYHF II-IV Heart Failure 914 0
Condition category
Condition code
Cardiovascular 981 981 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A non randomized study for the Cardiofit â¿¢ system, involving implantation of active neurostimulator for vagal stimulation. The surgical procedure will take approximately an hour and will be conducted under general anesthesia. Overall study duration is estimated at 18 months, consists of 12 months recruitment time. Nevertheless, patients will be followed up to 3 years post implantation in 6 months interval.
Intervention code [1] 737 0
Treatment: Devices
Comparator / control treatment
Control group
Historical

Outcomes
Primary outcome [1] 1303 0
Safety: Incidence of all adverse events
Timepoint [1] 1303 0
Secondary outcome [1] 2332 0
The secondary outcome will measure the CardiFit (TM) efficacy according to the listed parameters: NYHA functional class; QoL, Exercise capacity;Oxegen consumption; Ejection fraction; Circulating cytokines.
Timepoint [1] 2332 0
Outcome measurements will take place at each follow up visit at 1,2,3,4,5 and 6 months post parameter setting of the system.

Eligibility
Key inclusion criteria
1. NYHA II-IV2. Resting HR>70 and HR<1303. EF<35%4. Patient capable to perfom walking test.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Life threatening condition2. Acute MI3. Cerebral vascular accident4. CABG or PTCA in the last 3 months5. Acute myocarditis6. Constrictive pericarditis, aortic stenosis 7.Acure reanl of hepatic failure8. Anatomical defect that preclude use of device9.Hypotension10. Mitral stenosis11.Active peptic disease12. Asthma, severe COPD13. AV block of 1-3 degree14. Atrial fibrilation15. Long QT syndrome16. Glaucoma17. immunosuppressed patients18. LBBB.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1078 0
Commercial sector/Industry
Name [1] 1078 0
Country [1] 1078 0
Primary sponsor type
Commercial sector/Industry
Name
BioControl Medical
Address
Country
Israel
Secondary sponsor category [1] 939 0
None
Name [1] 939 0
none
Address [1] 939 0
Country [1] 939 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36305 0
Address 36305 0
Country 36305 0
Phone 36305 0
Fax 36305 0
Email 36305 0
Contact person for public queries
Name 9926 0
Shirley Giorini-Silfen
Address 9926 0
7 Vernon St
Glen Iris VIC 3146
Country 9926 0
Australia
Phone 9926 0
+61 3 98860335
Fax 9926 0
Email 9926 0
[email protected]
Contact person for scientific queries
Name 854 0
Dr. Harry Mond
Address 854 0
Cardiology Department
Royal Melbourne Hospital
City Campus
Grattan St
Parkville VIC 3050
Country 854 0
Australia
Phone 854 0
+61 3 93427133 ext.7076
Fax 854 0
Email 854 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.