Randomized trial to study the efficacy and adverse effects of the subcutaneous ICD in patients with a class I or IIa indication for ICD without an indication for pacing

The use of implantable cardioverter defibrillators (ICDs) is an established
therapy for the prevention of death from ventricular arrhythmia. Recently a new
subcutaneous ICD (S-ICD) has been introduced, eliminating the need for
transvenous lead placement in or on the heart which is mandatory in the
transvenous ICD (TV-ICD). The new S-ICD therapy already proved to be feasible
and safe and is an accepted therapy in Europe. It is likely that the eliminated
need for transvenous lead placement substantially reduces the implantation
related complications and inappropriate shock therapies and elongates lead
longevity. On the other hand it is unclear whether the lack of capability to
provide antitachy-pacing (ATP) in the S-ICD may be a limitation for patients
with frequent recurrent ventricular tachycardia. This randomized controlled
trial will outline the advantages and disadvantages of the S-ICD.

To determine the efficacy endpoint whether the lack of ATP function will
cause more appropriate but unnecessary shock therapy in patients with a
S-ICD. Furthermore we will study the complication endpoint whether the S-ICD is
superior to the TV-ICD in respect to major adverse events (i.e. inappropriate
shocks, acute and chronic implant related complications and lead- or device
related complications).

Single center, randomized controlled, prospective proof of concept trial with
either treatment with the TV-ICD or S-ICD.

none

Possibly there are more appropriate but unnecessary shocks in patients treated
with the S-ICD. However, we also expect less inappropriate shocks, less
complications and a better longevity of the ICD leads. The total amount of
shocks will be diminished, according to our expectation.