A PRospective, rAndomizEd Comparison of subcuTaneOous and tRansvenous ImplANtable Cardioverter Defibrillator Therapy
Status unconfirmed · Not applicable
Conditions studied: Ventricular Arrhythmias
In brief
This randomized controlled trial will outline the advantages and disadvantages of the subcutaneous implantable cardioverter defibrillator (ICD) compared to the transvenous ICD.
Key facts
- Study ID
- NCT01296022
- Run by
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- People needed
- 850
- Starts
- 2011-02-01
- Expected to finish
- 2023-12-01
- Last updated by the study team
- 2023-05-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Yale-New Haven Hospital — New Haven, Connecticut, United States
- Emory University Hospital — Atlanta, Georgia, United States
- Northwestern Memorial Hospital — Chicago, Illinois, United States
- The University of Chicago Medicine — Chicago, Illinois, United States
- Englewood Hospital and Medical Center — Englewood, New Jersey, United States
- The Valley Hospital — Ridgewood, New Jersey, United States
- Mount SinaÏ Hospital — New York, New York, United States
- Columbia University — New York, New York, United States
- Weill Cornell Medical College — New York, New York, United States
- Ohio State University Wexner Medical Center — Columbus, Ohio, United States
- Na Homolce Hospital — Prague, Czechia
- Rigshospitalet — Copenhagen, Denmark
- Herzzentrum Dresden — Dresden, Germany
- Universitätsklinikum Jena — Jena, Germany
- Universtätsklinikum Kiel — Kiel, Germany
- Herzzentrum Leipzig — Leipzig, Germany
- Universitätsklinikum Mannheim — Mannheim, Germany
- University Hospital Grosshadern — Munich, Germany
- Universitätsklinikum Wurzburg — Würzburg, Germany
- Noordwest Hospital — Alkmaar, Netherlands
- Flevoziekenhuis — Almere Stad, Netherlands
- Academic Medical Center - University of Amsterdam (AMC-UvA) — Amsterdam, Netherlands
- Onze Lieve Vrouwe Gasthuis — Amsterdam, Netherlands
- VU Medical Center — Amsterdam, Netherlands
- Amphia Hospital — Breda, Netherlands
Full record on ClinicalTrials.gov
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