← Back to Search

Procedure

Laminar Device for Atrial Fibrillation

N/A
Waitlist Available
Led By Devi Nair, 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

Study 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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Efficacy
Primary Safety
Secondary outcome measures
Device-Related Thrombosis
Peri-Device Flow

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
24 Previous Clinical Trials
25,530 Total Patients Enrolled
Laminar, Inc.Lead Sponsor
3 Previous Clinical Trials
119 Total Patients Enrolled
3 Trials studying Atrial Fibrillation
119 Patients Enrolled for Atrial Fibrillation
Devi Nair, MDPrincipal InvestigatorSt. Bernards Medical Center
1 Previous Clinical Trials
109 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for participants in this research study?

"As per clinicaltrials.gov, the investigation is not actively enrolling volunteers at present. Originally submitted on February 22, 2024, with the most recent update on March 1, 2024. Despite its current inactivity, there are a substantial number of 1528 alternative trials presently open for participant recruitment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Laminar LAAX Pivotal IDE Study
2024. "Laminar LAAX Pivotal IDE Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06168942.
~1000 spots leftby Aug 2028
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top