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NCT03040622 · ClinicalTrials.gov registry record
The Evaluation of Thrombogenicity in Patients Undergoing WATCHMAN Left Atrial Appendage Closure Trial
A clinical trial of Left Atrial Appendage Closure and WATCHMAN Device Implantation, sponsored by Inova Health Care Services.
- Completed
- Registry status
- 35
- Enrollment target
- 1
- Study location
NCT03040622: Completed study of Left Atrial Appendage Closure and WATCHMAN Device Implantation, sponsored by Inova Health Care Services.
NCT03040622 is a study of Left Atrial Appendage Closure and WATCHMAN Device Implantation that has completed, run by Inova Health Care Services. The registered enrollment target is 35 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03040622, a study of Left Atrial Appendage Closure and WATCHMAN Device Implantation, has completed, sponsored by Inova Health Care Services.
- COMPLETED
- Registry status
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate thrombogenicity in patients undergoing left atrial appendage closure using the WATCHMAN device. Parameters of thrombosis and platelet function, as well as other bio-markers, will be measure before, during, and after WATCHMAN implantation at several follow up visits.
Primary Outcome
Comparison of thrombin induced platelet-fibrin clot strength (TIP-FCS) as measured using thromboelastography (TEG-6s) between patients with and without device related thrombosis (DRT) assessed by transesophageal echocardiogram after left atrial appendage closure (LAAC) with Watchman device. TIP-FCS \>67mm has been associated with increased risk of hypercoagulability.
Conditions Studied
Interventions
- DEVICE WATCHMAN Left Atrial Appendage Closure
Study Locations (1)
Virginia
- Inova Fairfax Hospital - Falls Church
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2017-03-01 |
| Est. Completion | 2019-12-31 |
What the finished NCT03040622 record still lists
NCT03040622 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 35 participants, a relatively small participant target.
The record links to 2 conditions, with Left Atrial Appendage Closure appearing as the primary indexed condition, and to 1 intervention - of which WATCHMAN Left Atrial Appendage Closure is the first listed.
NCT03040622 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT03040622 about?
NCT03040622 is a clinical study titled "The Evaluation of Thrombogenicity in Patients Undergoing WATCHMAN Left Atrial Appendage Closure Trial". This study will evaluate thrombogenicity in patients undergoing left atrial appendage closure using the WATCHMAN device. Parameters of thrombosis and platelet function, as well as other bio-markers, will be measure before, during, and after WATCHMAN implantation at several follow up visits.
What is the current status of trial NCT03040622?
This trial is currently completed. The enrollment target is 35 participants. The study started on 2017-03-01. Estimated completion is 2019-12-31.
What conditions does trial NCT03040622 study?
This clinical trial studies the following conditions: Left Atrial Appendage Closure, WATCHMAN Device Implantation.
What interventions are being tested in trial NCT03040622?
The interventions under investigation include: WATCHMAN Left Atrial Appendage Closure (DEVICE).
Who is sponsoring clinical trial NCT03040622?
This trial is sponsored by Inova Health Care Services, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03040622 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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