To compare acute cardiotoxicity, measured by Troponin difference pre- and post-implantation, induced by implantation and defibrillation testing of transvenous and subcutaneous ICDs.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Delta troponin level pre versus post ICD implantation
Secondary outcome
Not applicable
Background summary
The new subcutaneous ICD requires more energy to meet the defibrillation
requirements and may therefore cause more myocardial injury than the lower
energy shocks from transvenous devices, but lacks an endocardial lead and may
in that respect actually cause less myocardial injury. One previous animal
study by Killingworth et al. compared cardiac enzyme release after implantation
and five shocks at maximum output. Four pigs were implanted with a transvenous
ICDs (35 Joules per shock) and four with a subcutaneous ICDs (65 Joules per
shock). The interesting result from this study was that only in the
transvenous ICD group the cardiac enzymes increased and in none of the pigs
implanted with a subcutaneous ICD. This indicates that transvenous ICD
implantation and testing causes myocardial injury, whether implantation and
subsequent mandated device test of a subcutaneous ICD does not cause myocardial
injury. However, no human data on cardiac injury after subcutaneous ICD
implantation and testing has been published thus far.
Study objective
To compare acute cardiotoxicity, measured by Troponin difference pre- and
post-implantation, induced by implantation and defibrillation testing of
transvenous and subcutaneous ICDs.
Study design
This study is a prospective non-randomized comparison three study arms.
- Arm A: 20 patients with de novo transvenous ICD implantation that
subsequently undergo defibrillation threshold testing.
- Arm B: 20 patients with transvenous ICD pulse generator replacement that
subsequently undergo defibrillation threshold testing.
- Arm C: 20 patients with de novo subcutaneous ICD implantation that
subsequently undergo defibrillation threshold testing.
- Arm D: 20 patients with de novo transveneus ICD implantation that do
not undergo subsequent defibrillation testing.
Study burden and risks
Prior to the implantation of the ICD, a blood sample will be drawn from the
intravenous line that is place as part of routine care. Six to eight hours
after defibrillation threshold testing a second blood sample will be drawn from
the IV-line.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Patients with an ICD indication, according to the European society of cardiology guidelines, who will undergo ICD implantation.
Exclusion criteria
- (Potential) pregnancy
Design
Recruitment
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 | NL55212.018.15 |