First Arrhythmia Collection of Transvenous and Simultaneous Subcutaneous Implantable Defibrillator Data (FACTS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01161589|
Recruitment Status : Completed
First Posted : July 13, 2010
Last Update Posted : February 16, 2017
|Condition or disease|
|Ventricular Tachycardia Ventricular Fibrillation Atrial Fibrillation|
The FACTS S-ICD study is a data gathering study that takes place during the implant procedure of a standard T-ICD system. Patients undergoing a routine dual chamber, dual high voltage shocking coil T-ICD or CRT-D insertion or replacement will be connected to an external data recorder via sterile cables. Atrial and ventricular arrhythmias will be induced while multiple ECG views are simultaneously recorded from both intracardiac and surface vectors. These episodes will then be digitized to create the FACTS S-ICD arrhythmia library.
As both dedicated and integrated bipolar sensing configurations are currently utilized in the marketplace, data will be collected using both market available ICD sensing methods.
The FACTS S-ICD study will enroll a sufficient quantity of patients such that a minimum of 50 atrial and 50 ventricular arrhythmic episodes are collected via both dedicated and integrated ICD systems. S-ICD signals will be collected for all recorded episodes.
The T-ICD implant procedure will be completed as per normal hospital practice and no further patient dependent data gathering will be required past the implant surgery and point of surgery arrhythmia inductions.
- Age 18 or above, or legal age to give consent specific to state and national law.
- Any patient undergoing a clinically indicated initial dual chamber T-ICD or CRT-D implantation. In addition, patients who require replacement of an existing dual chamber T-ICD or CRT-D system will be eligible for enrollment in the study.
- Patient will have a subcutaneous, left pectoral defibrillator implant.
- Patients unable or unwilling to provide informed consent.
- Any condition which precludes the subject's ability to comply with the study requirements, including completion of the study.
- Patients in chronic atrial fibrillation who have not been in sinus rhythm within the last six months.
- Enrollment in a concurrent study, without Cameron Health's written approval, that may confound the results of this study.
- Women who are pregnant or who are trying to become pregnant Note: Women of child bearing potential must have a negative pregnancy test within 7 days prior to defibrillator implant.
- Patient requires left sub-muscular or right sided defibrillator implant
|Study Type :||Observational|
|Actual Enrollment :||142 participants|
|Official Title:||First Arrhythmia Collection of Transvenous and Simultaneous Subcutaneous Implantable Defibrillator Data|
|Study Start Date :||October 2005|
|Primary Completion Date :||November 2008|
|Study Completion Date :||November 2008|
- Collection of simultaneous cardiac signals representing S-ICD and ICD sensing vectors [ Time Frame: 3 years ]This study will enroll a sufficient number of patients such that a minimum of 50 atrial and 50 ventricular arrhythmic episodes are collected by dedicated and integrated ICD systems and by the simulated S-ICD system
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01161589
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Erasmus Medical Centre|
|Rotterdam, Netherlands, 3000 CA|