CardioFit(TM) for heart Failure

Phase 1

• Conditions: YHF II-IV Heart Failure; NYHF II-IV Heart Failure; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12605000758606
• Lead Sponsor: BioControl Medical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-11-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. NYHA II-IV2. Resting HR>70 and HR<1303. EF<35%4. Patient capable to perfom walking test.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety: Incidence of all adverse events[]

Secondary Outcome Measures

Name	Time	Method
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.[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.]