To determine the performance of CardioFit* for the treatment of Class II-IV Heart Failure patients with preserved left ventricular function
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety endpoints: The incidence of all adverse events (system and/or procedure
related).
Performance endpoints: NYHA class; QoL; Exercise capacity (by 6-min walk);
Oxygen consumption (peak VO2); Ejection fraction; Circulating cytokines, and
N-Terminal Pro-BNP.
Secondary outcome
not applicable
Background summary
The prognosis for heart failure patients is poor, with only 50% of class III
patients surviving more than 2 years after diagnosis.
Although many pharmaceutical and other approaches to treatment of heart failure
are currently available, there is still an urgent need for new therapies for
these patients.
As shown by Schwartz et al. vagal stimulation might reduce the occurrence of
sudden death associated with healed myocardial infarction
Study objective
To determine the performance of CardioFit* for the treatment of Class II-IV
Heart Failure patients with preserved left ventricular function
Study design
Prospective, self-controlled interventional study composed of 5 periods: pre
implantation, implantation, activation, follow-up (with active device) and
post-study period with the device active.
Intervention
System implantation, device activation in a stepwise fashion to achieve optimal
stimulation. Treatment and observation.
Study burden and risks
The potential risks associated with this study are the known risks of surgery,
anesthesia, and electrical stimulation. Although the risk involved with
anesthesia and surgery is increased in the heart failure population, the
sponsor and the investigators have determined that this study is justified
because of the potential benefit of the CardioFit* treatment on patient's heart
failure symptoms and prognosis.
3 Geron St.
Yehud 56100
Israel
3 Geron St.
Yehud 56100
Israel
Listed location countries
Age
Inclusion criteria
diastolic heartfailure NYHA II-IV with EF > 50%
stable patients
Nt pro bnp > 200 pg/ml
resting heart rate between 70-130
signed informed consent
Exclusion criteria
presence of life threatening condition other than heart failure
definite or probable pulmonary disease
significant renal dysfunction
cabg, pci, acs or valve replacement in last 3 months or planned for next 12 months
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL28953.068.09 |