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NCT01161589 · ClinicalTrials.gov registry record
First Arrhythmia Collection of Transvenous and Simultaneous Subcutaneous Implantable Defibrillator Data
A clinical trial of Atrial Fibrillation and Ventricular Tachycardia, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- 142
- Enrollment target
- 4
- Study locations
NCT01161589: Completed study of Atrial Fibrillation and Ventricular Tachycardia, sponsored by Boston Scientific Corporation.
NCT01161589 is a study of Atrial Fibrillation and Ventricular Tachycardia that has completed, run by Boston Scientific Corporation. The registered enrollment target is 142 participants, below the 2,996-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (95% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01161589, a study of Atrial Fibrillation and Ventricular Tachycardia, has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- 142 participants
- Enrollment target
- 4
- Study locations
Study 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 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.
Primary Outcome
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
Conditions Studied
Study Locations (4)
Illinois
- University of Chicago - Chicago
South Carolina
- Medical University of South Carolina - Charleston
Virginia
- Virginia Commonwealth University - Richmond
Other
- Erasmus Medical Centre - Rotterdam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 142 participants |
| Start Date | 2005-10 |
| Est. Completion | 2008-11 |
What the finished NCT01161589 record still lists
NCT01161589 is an observational study that tracks outcomes without assigning an intervention. The registered 142 participants enrollment target is mid-sized for trials with a published cap, below the 2,996-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (95% lower).
The record links to 3 conditions, with Atrial Fibrillation appearing as the primary indexed condition, and to 0 interventions.
NCT01161589 reports a single indexed study location in Illinois, South Carolina, Virginia.
Frequently Asked Questions
What is clinical trial NCT01161589 about?
NCT01161589 is a clinical study titled "First Arrhythmia Collection of Transvenous and Simultaneous Subcutaneous Implantable Defibrillator Data". 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 com...
What is the current status of trial NCT01161589?
This trial is currently completed. The enrollment target is 142 participants. The study started on 2005-10. Estimated completion is 2008-11.
What conditions does trial NCT01161589 study?
This clinical trial studies the following conditions: Atrial Fibrillation, Ventricular Tachycardia, Ventricular Fibrillation.
Who is sponsoring clinical trial NCT01161589?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01161589 being conducted?
This trial has 4 study locations across Illinois, South Carolina, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01161589's enrollment target sits among peer trials
142 124th of 202 higher than 79 of 202 other Atrial Fibrillation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atrial Fibrillation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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