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A Pivotal Investigational Device Exemption Study on Laminar Left Atrial Appendage Elimination

NCT06168942 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1500

Last updated 2026-05-08

No results posted yet for this study

Summary

The purpose of this study is to compare the safety and effectiveness of Laminar Left Atrial Appendage Closure (LAAC) device as compared to the commercially available LAAC devices in participants with non-valvular atrial fibrillation (NVAF) to reduce the risk of stroke (blocked blood vessel or bleeding in brain) and systemic embolism (blockage in a blood vessel harming vital organs).

Conditions

  • Non-valvular Atrial Fibrillation
  • Stroke
  • Systemic Embolism

Interventions

DEVICE

Experimental: Laminar Left Atrial Appendage Closure System

Treatment with the Laminar Left Atrial Appendage Closure System.

DEVICE

Active Comparator: WATCHMAN / Amulet

Treatment with a WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder.

Sponsors & Collaborators

  • Biosense Webster, Inc.

    lead INDUSTRY

Principal Investigators

  • Saibal Kar, MD · Los Robles Health System

  • Devi Nair, MD · St. Bernards Heart and Vascular Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-19
Primary Completion
2028-12-01
Completion
2032-02-29
FDA Device
Yes

Countries

  • United States
  • Belgium
  • Czechia
  • Denmark
  • France
  • Germany
  • Italy
  • Lithuania
  • Netherlands
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06168942 on ClinicalTrials.gov