An interventional study of device settings for group A and Device settings for group B in Cardiac Death, sponsored by Abbott Medical Devices. Completed at 34 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-04.
Sponsored by Abbott Medical Devices (part of Abbott) · Not applicable, Interventional, and Treatment
The purpose of this study is to determine efficacy of a dedicated programming concept for avoidance of inappropriate implantable cardioverter defibrillator (ICD) therapies in patient with primary prevention ICD indication.
Inappropriate ICD therapies still remains a major issue with respect to patient's quality of life and proarrhythmic risk.
It's the aim of this study to determine efficacy of a dedicated programming concept for avoidance of inappropriate ICD therapy in patients who received the ICD for primary prevention of sudden cardiac death.
583 studies on the registry are indexed under Death; 109 are open to participants now.
This study's enrollment of 543 is above the median of 131 across 267 interventional studies indexed under Death.
Browse Death studies →Abbott Medical Devices is the lead sponsor of 539 studies on the registry; 33 are open to participants now.
Of its 53 completed or terminated interventional studies of FDA-regulated products, 44 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Group A: * VT zone: 350ms * VF zone: 280ms
Device: device settings for group A
Group B: * VT zone: 320ms * VF zone: 250ms
Device: Device settings for group B
VT zone: 350ms VF zone: 280ms
Also known as: Control group
VT zone: 320ms VF zone: 250ms
Also known as: Treatment group
Primary Endpoint
Event free survival of: 1. inappropriate ICD therapies (only stored tachycardias with proper stored EGM documentation are taken into account) AND 2. spontaneous, documented, sustained (\>30s) ventricular tachycardia, that was not treated by the ICD
Time frame: 12 months
Amount of patients with appropriate / inappropriate ICD therapies
Time frame: 12 months
Prevalence of slow VT (<=187bpm) in patients with indication for primary prevention of SCD
Time frame: 12 months
Number and cycle lengths of supraventricular / ventricular tachys
Time frame: 12 months
Time to first appropriate / inappropriate ICD therapy
Time frame: 12 months
Sensitivity for diagnosis of sustained VT
Time frame: 12 months
Specificity for SVT diagnosis
Time frame: 12 months
Quality of Life (MLHF Questionaire)
Time frame: 12 months
Overall mortality
Time frame: 12 months
Cardiac mortality
Time frame: 12 months
Frequency and efficacy of ATP prior to / before capacitor charging in VF zone
Time frame: 12 months
Amount of patients with appropriate / inappropriate shocks or ATP
Time frame: 12 months
The record gives a start of Aug 2009, a primary completion of Sep 2012 and a completion of Jan 2013. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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