Randomized Trial to Study the Efficacy and Adverse Effects of the Subcutaneous and Transvenous Implantable Cardioverter Defibrillator (ICD) in Patients With a Class I or IIa Indication for ICD Without an Indication for Pacing
This randomized controlled trial will outline the advantages and disadvantages of the subcutaneous implantable cardioverter defibrillator (ICD) compared to the transvenous ICD.
Objectives of the study: (1) To compare the subcutaneous ICD to the transvenous ICD for major adverse events (i.e. inappropriate shocks, acute and chronic implant related complications and lead- or device related complications). (2) To determine to which degree the lack of ATP function leads to more appropriate shocks in patients with a subcutaneous ICD.
Study design: Multicenter, prospective, randomized controlled trial with either treatment with the transvenous ICD or subcutaneous ICD (1:1).
Study population: 2x425 patients with class I or IIa indication for ICD therapy without an indication for pacing.
18 Years and up
Accepting Healthy Volunteers?
- Patients 18 years and older
- Patients with class I or IIa indication for ICD therapy according to the ACC/AHA/ESC 2006 Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death
- Patients with documented therapy refractory monomorphic ventricular tachycardia
- Patients having an indication for pacing therapy
- Patients with ventricular tachycardia less than 170 bpm
- Patients failing appropriate QRS/T-wave sensing with the S-ICD ECG patient screening tool provided by Cameron Health/Boston Scientific
- Patients with incessant ventricular tachycardia
- Patients with a serious known concomitant disease with a life expectancy of less than one year
- Patients with circumstances that prevent follow-up (no permanent home or address, transient, etc.)
- Patients who have had a previous ICD implant
- Patient who receive cardiac contractility modulation therapy or are likely to receive cardiac contractility modulation therapy.
- Patients who are unable to give informed consent