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NCT03688412 · ClinicalTrials.gov registry record
Transvenous Lead Removal Post-Market Clinical Study
A clinical trial of Cardiac Electrophysiology, sponsored by Cook Research Incorporated.
- Completed
- Registry status
- 230
- Enrollment target
- 9
- Study locations
NCT03688412: Completed study of Cardiac Electrophysiology, sponsored by Cook Research Incorporated.
NCT03688412 is a study of Cardiac Electrophysiology that has completed, run by Cook Research Incorporated. The registered enrollment target is 230 participants. The trial reports 9 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03688412, a study of Cardiac Electrophysiology, has completed, sponsored by Cook Research Incorporated.
- COMPLETED
- Registry status
- 230 participants
- Enrollment target
- 9
- Study locations
Study Summary
This prospective, multicenter, post-market clinical study was designed to evaluate the outcomes of lead extraction of cardiovascular implantable electronic devices (CIED) using Cook catheter and lead extraction devices for any indication it is used in the commercial setting within the United States and Europe. The purpose of this clinical study is to collect data on the performance of the Cook lead extraction devices for the purpose of supporting publications and presentations
Primary Outcome
Complete procedural success is the removal of the targeted lead and all lead material from the vascular space, with the absence of permanently disabling complications or procedure-related death.
Conditions Studied
Interventions
- DEVICE Cook lead extraction devices
Study Locations (9)
Other
- German Heart Center Berlin - Berlin
- Isala - Zwolle
- St. George's University Hospital - London
California
- UCSF Medical Center - San Francisco
Illinois
- Carle Foundation - Urbana
North Carolina
- NC Heart and Vascular Reseach - Raleigh
Pennsylvania
- Wellspan York Hospital - York
Texas
- Memorial Hermann - Houston
Virginia
- University of VA Medical Center - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Start Date | 2018-10-18 |
| Est. Completion | 2020-05-11 |
What the finished NCT03688412 record still lists
NCT03688412 is an observational study that tracks outcomes without assigning an intervention. The registered 230 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Cardiac Electrophysiology appearing as the primary indexed condition, and to 1 intervention - of which Cook lead extraction devices is the first listed.
NCT03688412 lists 9 locations in 7 states (Other, California, Illinois).
Frequently Asked Questions
What is clinical trial NCT03688412 about?
NCT03688412 is a clinical study titled "Transvenous Lead Removal Post-Market Clinical Study". This prospective, multicenter, post-market clinical study was designed to evaluate the outcomes of lead extraction of cardiovascular implantable electronic devices (CIED) using Cook catheter and lead extraction devices for any indication it is used in the commercial setting within the United States ...
What is the current status of trial NCT03688412?
This trial is currently completed. The enrollment target is 230 participants. The study started on 2018-10-18. Estimated completion is 2020-05-11.
What conditions does trial NCT03688412 study?
This clinical trial studies the following conditions: Cardiac Electrophysiology.
What interventions are being tested in trial NCT03688412?
The interventions under investigation include: Cook lead extraction devices (DEVICE).
Who is sponsoring clinical trial NCT03688412?
This trial is sponsored by Cook Research Incorporated, which has 24 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03688412 being conducted?
This trial has 9 study locations across California, Illinois, North Carolina, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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