A Clinical Evaluation of ST Changes in a Group of Patients Having Ventricular Arrhythmias (inSighT)
|ClinicalTrials.gov Identifier: NCT01685047|
Recruitment Status : Completed
First Posted : September 13, 2012
Last Update Posted : April 22, 2016
|Condition or disease|
|Coronary Artery Disease|
|Study Type :||Observational|
|Actual Enrollment :||481 participants|
|Observational Model:||Case Control|
|Official Title:||A Clinical Evaluation of ST Changes in a Group of Patients Having Ventricular Arrhythmias|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||April 2016|
Group 1 uses Merlin.net for remote monitoring, i.e. scheduled follow ups every 6 months in clinic, collection of ST Segment, ATP and Shock Therapy delivered alerts via Merlin.net.
Group 2 will not use Merlin.net, i.e. scheduled follow ups every 3 months in clinic for alert review during device interrogation.
The use of Merlin.net will be per physician's preference.
- Among patients with an appropriate ICD therapy (shock or ATP) for ventricular tachycardia or fibrillation, determine the proportion of patients who have characterized ST segment changes from baseline prior to the therapy. [ Time Frame: End of follow up period ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01685047
|Bad Nauheim, Germany, D-61231|
|Principal Investigator:||Johannes SPERZEL, MD||Kerckhoff Klinik, Bad Nauheim Germany|