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LAA Exclusion Device
VClip Post-Market Study
N/A
Waitlist Available
Led By Elias Zias, MD
Research Sponsored by AtriCure, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-months or greater post-procedure
Awards & highlights
No Placebo-Only Group
Summary
This trial studies two medical devices, AtriClip® FLEX-V LAA and PRO•V LAA, used to close off a small part of the heart called the left atrial appendage. The devices are tested on patients who are already undergoing other heart surgeries. By closing off this part of the heart, the devices help prevent blood clots and reduce the risk of stroke.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12-months or greater post-procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-months or greater post-procedure
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Primary Performance Endpoint
Primary Safety Endpoint
Secondary study objectives
Device and Procedure long-term Safety
Long-term thromboembolic events
Performance
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: AtriClip groupExperimental Treatment1 Intervention
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Who is running the clinical trial?
AtriCure, Inc.Lead Sponsor
42 Previous Clinical Trials
18,615 Total Patients Enrolled
Elias Zias, MDPrincipal InvestigatorNYU Langone Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: AtriClip group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.