cardiomyopathy disorder of the heart muscle
Conditions
Interventions
- Enhanced ICD programming:
VT monitor: > 166/min
fVT: > 182/min
via VF 60/80 intervals (number of intervals to start ATP after
approximately 20 s)
3 x ATP (8 stimuli, 88%, scan 20 ms)
shock 1-5: 35 J
redetection 30/40 intervals
VF: > 250/min
via VF 60/80 intervals (number of intervals to start therapy
after approximately 15 s)
1 x ATP (8 stimuli, 88%) during charging
all
shocks: 35 J
redetection 30/40 intervals
SVT/VT discrimination is turned on, high rate time out is *OFF*
SVT/VT discrimination single chamber: stability, wavelet
SVT upper rate limit:
222/min
SVT/VT discrimination dual/triple chamber: P/R logic, wavelet
SVT upper rate
limit: 222/min
T-wave oversensing and lead noise discrimination is turned on in all devices
1) In patients with known sustained VT*s the VT zone may be programmed to lower
heart rate
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients implanted with a Medtronic ProtectaTM ICD (VR or DR) or CRT-D, between 18-80 years of age, with a primary or secondary prophylactic indication for ICD therapy according to the current European guidelines, speaking and understanding Dutch, and providing written informed consent will be eligible to participate.
Exclusion criteria
Exclusion criteria: Patients with a life expectancy less than 1 year, with a history of psychiatric illness other than affective/anxiety disorders, on the waiting list for heart transplantation or with insufficient knowledge of the Dutch language will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study outcome is safety of Enhanced programming within 12 months after implantation (combined endpoint): all arrhythmic syncopes and other intervention-related safety events (either hospitalization, death or other serious adverse event due to Enhanced programming. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study outcomes are: number of adverse events (adverse events related to ICD shock with consequences and adverse events related to syncopal/near syncopal events); number of appropriate/inappropriate and successful/unsuccessful ATPs/shocks; quality of life and distress (anxiety/depression). | — |
Countries
Netherlands
Outcome results
None listed