CardioFit(TM) for heart Failure

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.

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000758606

Enrollment

Registered

2005-11-18

Start date

2006-11-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

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.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

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.

Outcome results