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NCT02787291 · ClinicalTrials.gov registry record · NA
A Clinical Evaluation of the Durata or Optisure High Voltage Leads and Ellipse VR ICD Undergoing MRI, an IDE Study
A NA study of Implantable Defibrillator User, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- NA
- Development phase
- 227
- Enrollment target
- 20
- Study locations
NCT02787291 is a NA study of Implantable Defibrillator User that has completed, run by Abbott Medical Devices. The registered enrollment target is 227 participants, below the 832-participant average among 5 other Implantable Defibrillator User trials with a reported enrollment target (73% lower). The trial reports 20 study locations across 13 states.
The verdict
NCT02787291, a NA study of Implantable Defibrillator User, has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- NA
- Development phase
- 227 participants
- Enrollment target
- 20
- Study locations
Study Summary
To demonstrate safety and efficacy of the Durata or Optisure high voltage lead and Ellipse VR ICD in an MRI environment.
Conditions Studied
Interventions
- DEVICE Ellipse VR ICD and Durata/Optisure lead
Study Locations (20)
Pennsylvania
- Saint Vincent Consultants in Cardiovascular Diseases - Erie
- Pinnacle Health System - Harrisburg
- Penn State Milton S. Hershey Medical Center - Hershey
- Donald Guthrie Foundation for Education and Research - Sayre
California
- Central Cardiology - Bakersfield
- Scripps Health - La Jolla
Georgia
- Athens Regional Medical Center - Athens
- Redmond Regional Medical Center - Rome
Indiana
- Parkview Research Center - Fort Wayne
- Medical Consultants - Muncie
Michigan
- Sparrow Clinical Research Institute - Lansing
- Providence Hospital - Southfield
Arizona
- John C. Lincoln North Mountain Hospital - Phoenix
Florida
- Florida Hospital - Orlando
Illinois
- Prairie Education and Research Cooperative - Springfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 227 participants |
| Start Date | 2016-05 |
| Est. Completion | 2018-04-11 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02787291
The ClinicalTrials.gov registry entry for NCT02787291 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 227 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 832-participant average among 5 other Implantable Defibrillator User trials with a reported enrollment target (73% lower). The listed sponsor is Abbott Medical Devices, which has 261 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Implantable Defibrillator User appearing as the primary indexed condition, and to 1 intervention - of which Ellipse VR ICD and Durata/Optisure lead is the first listed.
NCT02787291 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Pennsylvania, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT02787291 about?
NCT02787291 is a clinical study titled "A Clinical Evaluation of the Durata or Optisure High Voltage Leads and Ellipse VR ICD Undergoing MRI, an IDE Study". To demonstrate safety and efficacy of the Durata or Optisure high voltage lead and Ellipse VR ICD in an MRI environment.
What is the current status of trial NCT02787291?
This trial is currently completed. It is a NA study. The enrollment target is 227 participants. The study started on 2016-05. Estimated completion is 2018-04-11.
What conditions does trial NCT02787291 study?
This clinical trial studies the following conditions: Implantable Defibrillator User.
What interventions are being tested in trial NCT02787291?
The interventions under investigation include: Ellipse VR ICD and Durata/Optisure lead (DEVICE).
Who is sponsoring clinical trial NCT02787291?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02787291 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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