SUSPENDED

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

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Conditions

Non-valvular Atrial FibrillationStrokeSystemic Embolism

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

Laminar Left Atrial Appendage Elimination (LAAX) Pivotal IDE Study

Quick Facts

Study Start:2024-02-19
Study Completion:2032-02-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:SUSPENDED

Study ID

NCT06168942

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Documented evidence of paroxysmal, persistent, or permanent non-valvular atrial fibrillation (NVAF)
  2. * CHA2DS2-VASc score greater than or equal to (\>=) 2 in men and \>= 3 in women
  3. * 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
  4. * Recommended for chronic oral anticoagulation therapy (OAC) but has an appropriate rationale to seek a non-pharmacologic alternative
  5. * Eligible for the protocol-specified post-procedural antithrombotic regimen
  6. * 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
  1. * Single episode, transient, or reversible atrial fibrillation (AF) (example, secondary to thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
  2. * Prior cardiac surgery or any procedure that involved pericardial access
  3. * 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
  4. * 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)
  5. * 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)

Contacts and Locations

Principal Investigator

Saibal Kar, MD
PRINCIPAL_INVESTIGATOR
Los Robles Health System
Devi Nair, MD
PRINCIPAL_INVESTIGATOR
St. Bernards Heart and Vascular Center

Study Locations (Sites)

Grandview Medical Center
Birmingham, Alabama, 35243
United States
Arizona Arrhythmia Research Group Phoenix Cardio Research Group PCRG
Phoenix, Arizona, 85018
United States
Tucson Medical Center
Tucson, Arizona, 85712
United States
Arrhythmia Research Group
Jonesboro, Arkansas, 72401
United States
Cedars Sinai Medical Center
Los Angeles, California, 90048
United States
Stanford Health Care
Palo Alto, California, 94303
United States
Univeristy of California Davis Health
Rancho Cordova, California, 95670
United States
Scripps Health
San Diego, California, 92121
United States
Providence Saint John's Health Center and the Pacific Heart Institute
Santa Monica, California, 90404
United States
Los Robles Regional Medical Center
Thousand Oaks, California, 91360
United States
NCH Healthcare
North Naples, Florida, 34102
United States
Piedmont Healthcare
Atlanta, Georgia, 30309
United States
Emory University
Atlanta, Georgia, 30322
United States
Memorial Health University Medical Center
Savannah, Georgia, 31404
United States
The Kansas City Heart Rhythm Institute
Overland Park, Kansas, 66211
United States
Baptist Health Lexington
Lexington, Kentucky, 40503
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Englewood Health
Englewood, New Jersey, 07631
United States
Northwell Health
Bay Shore, New York, 11706
United States
Montefiore Medical Center
Bronx, New York, 10467
United States
NYU Langone Health
New York, New York, 10016
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
Columbia University in the City of New York and The New York and Presbyterian Hospital
New York, New York, 10032
United States
Wake Forest University Health Sciences
Charlotte, North Carolina, 28203
United States
East Carolina University
Greenville, North Carolina, 27834
United States
Bethesda North Hospital Trihealth
Cincinnati, Ohio, 45202
United States
Lindner Clinical Trial Center/Christ Hospital
Cincinnati, Ohio, 45219
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Ohio State University
Columbus, Ohio, 43210
United States
Trident Medical Center
North Charleston, South Carolina, 29406
United States
TriStar Skyline Medical Center
Nashville, Tennessee, 37203
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
United States
University of Texas Medical Branch
Galveston, Texas, 77555
United States
Texas Heart Institute
Houston, Texas, 77030
United States
Baylor Scott & White Research Institute at The Heart Hospital Baylor Plano
Plano, Texas, 75093
United States
Heart Rhythm Associates
Shenandoah, Texas, 77380
United States
Swedish Medical Center
Seattle, Washington, 98122
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-19
Study Completion Date2032-02-29

Study Record Updates

Study Start Date2024-02-19
Study Completion Date2032-02-29

Terms related to this study

Additional Relevant MeSH Terms

  • Non-valvular Atrial Fibrillation
  • Stroke
  • Systemic Embolism