A PRospective, rAndomizEd Comparison of subcuTaneOous and tRansvenous ImplANtable Cardioverter De… (NCT01296022) | Clinical Trial Compass
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A PRospective, rAndomizEd Comparison of subcuTaneOous and tRansvenous ImplANtable Cardioverter Defibrillator Therapy
United States850 participantsStarted 2011-02
Plain-language summary
This randomized controlled trial will outline the advantages and disadvantages of the subcutaneous implantable cardioverter defibrillator (ICD) compared to the transvenous ICD.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
What they're measuring
1
Number of participants with implantable cardioverter defibrillator (ICD) related adverse events
Timeframe: 48 months
Trial details
NCT IDNCT01296022
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)