First Arrhythmia Collection of Transvenous and Simultaneous Subcutaneous Implantable Defibrillator Data
Completed
Conditions studied: Ventricular Tachycardia, Ventricular Fibrillation, Atrial Fibrillation
In brief
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 defibrillator system (S-ICD). Upon completion, this data will represent the first true database capable of comparing detection characteristics of transvenous and subcutaneous ICDs. Future protocols will be created to dictate the specific methods of such comparisons.
Key facts
- Study ID
- NCT01161589
- Run by
- Boston Scientific Corporation
- People needed
- 142
- Starts
- 2005-10-01
- Expected to finish
- 2008-11-01
- Last updated by the study team
- 2017-02-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Chicago — Chicago, Illinois, United States
- Medical University of South Carolina — Charleston, South Carolina, United States
- Virginia Commonwealth University — Richmond, Virginia, United States
- Erasmus Medical Centre — Rotterdam, Netherlands
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.