Clinical trial NCT06168942: A Pivotal Investigational Device Exemption Study on Laminar Left Atrial Appendage Elimination
Official title: Laminar Left Atrial Appendage Elimination (LAAX) Pivotal IDE Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-valvular Atrial Fibrillation
Stroke
Systemic Embolism
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2023-12-13
Enrollment: 1900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: This prospective, randomized, controlled, multicenter, open-label pivotal clinical study will enroll participants with non-valvular atrial fibrillation who are eligible for short-term anticoagulation therapy but have a rationale to seek non-pharmacologic alternative. Participants will be randomized 1:1 to the Laminar Left Atrial Appendage Closure System or commercially available device (WATCHMAN™ left atrial appendage closure device / Amulet™ left atrial appendage occluder).

Eligibility criteria: Inclusion 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: All-Cause Mortality
timeFrame: Up to 12 months
measure: Number of Participants With Major Bleeding According to the Bleeding Academic Research Consortium (BARC) Type III or V
timeFrame: Up to 12 months
measure: Number of Participants With Pericardial Effusion Requiring Drainage
timeFrame: Up to 12 months
measure: Number of Participants With Device Embolization
timeFrame: Up to 12 months
measure: Number of Participants With Device or Procedure-Related Events Requiring Open Cardiac Surgery or Major Endovascular Intervention
timeFrame: Up to 12 Months
measure: Number of Participants Reporting Ischemic Stroke or Systemic Embolism
timeFrame: Up to 18 Months
Secondary outcomes:
measure: Number of Participants With Peri-Device Flow
timeFrame: Up to 12 Months
measure: Rate of Device-Related Thrombosis
timeFrame: Up to 12 Months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Grandview Medical Center
state: Alabama
city: Phoenix
country: United States
facility: Arizona Arrhythmia Research Group Phoenix Cardio Research Group PCRG
state: Arizona
city: Tucson
country: United States
facility: Tucson Medical Center
state: Arizona
city: Jonesboro
country: United States
facility: Arrhythmia Research Group
state: Arkansas
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Palo Alto
country: United States
facility: Stanford Health Care
state: California
city: Rancho Cordova
country: United States
facility: Univeristy of California Davis Health
state: California
city: San Diego
country: United States
facility: Scripps Health
state: California
city: Santa Monica
country: United States
facility: Providence Saint John's Health Center and the Pacific Heart Institute
state: California
city: Thousand Oaks
country: United States
facility: Los Robles Regional Medical Center
state: California
city: North Naples
country: United States
facility: NCH Healthcare
state: Florida
city: Atlanta
country: United States
facility: Piedmont Healthcare
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Savannah
country: United States
facility: Memorial Health University Medical Center
state: Georgia
city: Overland Park
country: United States
facility: The Kansas City Heart Rhythm Institute
state: Kansas
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Englewood
country: United States
facility: Englewood Health
state: New Jersey
city: Bay Shore
country: United States
facility: Northwell Health
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University in the City of New York and The New York and Presbyterian Hospital
state: New York
city: Charlotte
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Cincinnati
country: United States
facility: Bethesda North Hospital Trihealth
state: Ohio
city: Cincinnati
country: United States
facility: Lindner Clinical Trial Center/Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: York
country: United States
facility: York Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: TriStar Skyline Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: Texas Heart Institute
state: Texas
city: Plano
country: United States
facility: Baylor Scott & White Research Institute at The Heart Hospital Baylor Plano
state: Texas
city: Shenandoah
country: United States
facility: Heart Rhythm Associates
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Aalst
country: Belgium
facility: AZORG campus Aalst Moorselbaan
city: Brugge
country: Belgium
facility: AZ Sint Jan Brugge Oostende AV
city: Bruxelles
country: Belgium
facility: C.H.U. Brugmann
city: Charleroi
country: Belgium
facility: CHU Charleroi Chimay
city: Prague
country: Czechia
facility: Nemocnice na Homolce
city: Copenhagen
country: Denmark
facility: Rigshospitalet Copenhagen University Hospital
city: Massy
country: France
facility: Hopital Prive Jacques Cartier
city: Toulouse
country: France
facility: Clinique Pasteur
city: Frankfurt a.M.
country: Germany
facility: MVZ CCB Frankfurt und Main Taunus GbR
city: Frankfurt am Main
country: Germany
facility: CVC CardioVascular Center Frankfurt
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
city: Massa
country: Italy
facility: Fondazione Toscana Gabriele Monasterio CNR
city: Milano
country: Italy
facility: Centro Cardiologico Monzino
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
city: Roma
country: Italy
facility: Policlinico Tor Vergata
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Clinics
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis Nieuwegein
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Poznan
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Poznaniu
city: Barcelona
country: Spain
facility: Hosp. de La Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Hosp Clinic de Barcelona
city: Madrid
country: Spain
facility: Hosp. Clinico San Carlos
city: Pamplona
country: Spain
facility: Clinica Univ. de Navarra
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Vigo
country: Spain
facility: Hosp. Alvaro Cunqueiro
Study officials:
affiliation: Los Robles Health System
name: Saibal Kar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Bernards Heart and Vascular Center
name: Devi Nair, MD
role: PRINCIPAL_INVESTIGATOR
References: