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Procedure

Left Atrial Appendage Closure Devices for Atrial Fibrillation

N/A
Waitlist Available
Led By Saibal Kar, MD
Research Sponsored by Laminar, 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 18 months
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to compare a new device, the Laminar Left Atrial Appendage Closure System, to existing devices used to prevent strokes in patients with atrial fibrillation. Participants will be randomly

Who is the study for?
This trial is for adults over 18 with non-valvular atrial fibrillation at high stroke risk who need an alternative to long-term blood thinners. Candidates should be suitable for a specific post-procedure drug regimen and have a CHA2DS2-VASc score indicating moderate to high stroke risk.
What is being tested?
The study compares the new Laminar Left Atrial Appendage Closure System with existing devices like WATCHMAN™/Amulet™ in preventing strokes in patients with atrial fibrillation. Participants are randomly assigned to one of the treatments.
What are the potential side effects?
While not specified here, typical side effects from such procedures may include bleeding, infection, heart or blood vessel complications, and reactions related to anesthesia or device materials.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Efficacy
Primary Safety
Secondary study objectives
Device-Related Thrombosis
Peri-Device Flow

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Laminar DeviceExperimental Treatment1 Intervention
Treatment with the Laminar Left Atrial Appendage Closure System.
Group II: Control LAACActive Control1 Intervention
Treatment with a commercially-available left atrial appendage closure device.

Find a Location

Who is running the clinical trial?

Cardiovascular Research Foundation, New YorkOTHER
26 Previous Clinical Trials
25,710 Total Patients Enrolled
Laminar, Inc.Lead Sponsor
3 Previous Clinical Trials
119 Total Patients Enrolled
Saibal Kar, MDPrincipal InvestigatorLos Robles Regional Medical Center
6 Previous Clinical Trials
6,065 Total Patients Enrolled
2 Trials studying Stroke
4,857 Patients Enrolled for Stroke
Devi Nair, MDPrincipal InvestigatorSt. Bernards Medical Center
2 Previous Clinical Trials
584 Total Patients Enrolled
~1000 spots leftby Aug 2028
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