Status:
COMPLETED
First Arrhythmia Collection of Transvenous and Simultaneous Subcutaneous Implantable Defibrillator Data
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Ventricular Tachycardia
Ventricular Fibrillation
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this clinical study is to collect simultaneous, multiple view cardiac signals representing both transvenous ICDs (T-ICD) and sensing vectors from the subcutaneous implantable defibrilla...
Detailed Description
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-...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT01161589
Start Date
October 1 2005
End Date
November 1 2008
Last Update
February 16 2017
Active Locations (4)
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1
University of Chicago
Chicago, Illinois, United States, 60637
2
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
3
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
4
Erasmus Medical Centre
Rotterdam, Netherlands, 3000 CA