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

Description

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

Talk to us

Study Overview

On this page

Study Details

Study overview

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).

Laminar Left Atrial Appendage Elimination (LAAX) Pivotal IDE Study

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

Condition
Non-valvular Atrial Fibrillation
Intervention / Treatment

-

Contacts and Locations

Birmingham

Grandview Medical Center, Birmingham, Alabama, United States, 35243

Phoenix

Arizona Arrhythmia Research Group Phoenix Cardio Research Group PCRG, Phoenix, Arizona, United States, 85018

Tucson

Tucson Medical Center, Tucson, Arizona, United States, 85712

Jonesboro

Arrhythmia Research Group, Jonesboro, Arkansas, United States, 72401

Los Angeles

Cedars Sinai Medical Center, Los Angeles, California, United States, 90048

Palo Alto

Stanford Health Care, Palo Alto, California, United States, 94303

San Diego

Scripps Health, San Diego, California, United States, 92121

Thousand Oaks

Los Robles Regional Medical Center, Thousand Oaks, California, United States, 91360

North Naples

NCH Healthcare, North Naples, Florida, United States, 34102

Atlanta

Piedmont Healthcare, Atlanta, Georgia, United States, 30309

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Documented evidence of paroxysmal, persistent, or permanent non-valvular atrial fibrillation (NVAF)
  • * CHA2DS2-VASc score greater than or equal to (\>=) 2 in men and \>= 3 in women
  • * Deemed to be clinically indicated for left atrial appendage (LAA) closure by the Site Investigator and a clinician not a part of the procedural team using an evidence-based decision-making tool in accordance with standard of care
  • * Recommended for chronic oral anticoagulation therapy (OAC) but has an appropriate rationale to seek a non-pharmacologic alternative
  • * Eligible for the protocol-specified post-procedural antithrombotic regimen
  • * Willing and able to comply with the protocol, and has provided written informed consent (participant or legally authorized representative) per institutional review board (IRB) requirements
  • * Single episode, transient, or reversible atrial fibrillation (AF) (example, secondary to thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
  • * Prior cardiac surgery or any procedure that involved pericardial access
  • * Stage IV kidney disease or Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) less than (\<) 30 milliliters per minute per (mL/min)/1.73 square meters (m\^2) or participants with end stage renal disease who are dialysis dependent
  • * Any cardiac or non-cardiac interventional or surgical procedures within 60 days prior to or any planned general surgery, cardiac surgery, or interventional procedure within 60 days after implant (including, but not limited to cardioversion, percutaneous coronary intervention (PCI), cardiac ablation, cataract surgery)
  • * Left atrial appendage anatomy which cannot accommodate either commercially available control device or the laminar implant per manufacturer instructions for use (IFU) (that is, the anatomy and sizing must be appropriate for a control and the Laminar device to be enrolled in the study)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Biosense Webster, Inc.,

Saibal Kar, MD, PRINCIPAL_INVESTIGATOR, Los Robles Health System

Devi Nair, MD, PRINCIPAL_INVESTIGATOR, St. Bernards Heart and Vascular Center

Study Record Dates

2032-02-29