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First Arrhythmia Collection of Transvenous and Simultaneous Subcutaneous Implantable Defibrillator Data
NCT01161589 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01161589
The ClinicalTrials.gov registry entry for NCT01161589 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 142 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Scientific Corporation, which has 120 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Atrial Fibrillation appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01161589 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Illinois, South Carolina, Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT01161589?
This trial is sponsored by Boston Scientific Corporation, which has 120 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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