Cardiac Arrhythmias Clinical Trial
Official title:
ENHANCED Device Programming to Reduce Therapies and Improve Quality of Life in Implantable Cardioverter Defibrillator Patients: A Prospective, Single-arm Safety Monitoring Study (ENHANCED-ICD Study)
The purpose of this study is to determine whether Enhanced device programming to reduce therapies (i.e. anti tachycardia pacing (ATP) episodes and shocks (both appropriate and inappropriate)) is safe for patients implanted with an Implantable Cardioverter-Defibrillator (ICD). The secondary objective is to examine the impact of Enhanced programming on (i) ATPs and shocks (both appropriate and inappropriate) and (ii) quality of life and distress.
ICD therapy has become the first-line treatment for the prevention of sudden cardiac death
both as primary and secondary prevention due to its proven survival benefits as compared to
anti-arrhythmic drugs. However, ICD therapy is associated with a number of complications and
shocks that may impair patient quality of life and well being but also influence mortality.
Hence, reduction of ICD shocks by means of alternative programming of the device is paramount
for improving patient-centered outcomes and mortality.
The ENHANCED-ICD study will be a prospective, single-arm safety monitoring study. All
patients will receive Enhanced programming. Furthermore, patients will be asked to complete a
set of standardized and validated self-report questionnaires prior to ICD implantation, at
3-, 6-, and 12 months post implantation.
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