A Pivotal Investigational Device Exemption Study on Laminar Left Atrial Appendage Elimination
- Conditions
- Non-valvular Atrial FibrillationStrokeSystemic Embolism
- Registration Number
- NCT06168942
- Lead Sponsor
- Biosense Webster, Inc.
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1900
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method All-Cause Mortality Up to 12 months Composite rate of all-cause mortality will be reported.
Number of Participants With Major Bleeding According to the Bleeding Academic Research Consortium (BARC) Type III or V Up to 12 months The number of participants with major bleeding, according to the BARC type III or V, will be reported.
Type III
1. Type IIIa includes overt bleeding plus a hemoglobin drop of 3 to less than (\<) 5 grams per deciliter (g/dL) related to bleeding and any transfusion with overt bleeding.
2. Type IIIb involves overt bleeding plus a hemoglobin drop of greater than or equal to (\>=) 5 g/dL related to bleeding, cardiac tamponade, bleeding requiring surgical intervention for control, or bleeding requiring intravenous vasoactive agents.
3. Type IIIc includes intracranial hemorrhage, with subcategories confirmed by autopsy, imaging, or lumbar puncture, as well as intraocular bleeding compromising vision.
Type V
1. Type Va: Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious.
2. Type Vb: Definite fatal bleeding; overt bleeding or autopsy or imaging confirmation.Number of Participants With Pericardial Effusion Requiring Drainage Up to 12 months Participants with pericardial effusion requiring drainage will be reported. Pericardial effusion is defined as 1) Clinically non-relevant: requiring no intervention, treated pharmacologically and 2) Clinically relevant: treated with therapeutic intervention (pericardiocentesis, surgical intervention, blood transfusion) and/or result in shock or death.
Number of Participants With Device Embolization Up to 12 months Participants with device embolization will be reported. Device embolization is defined as movement of a medical device to an unintended location within the body with resulting obstruction of an organ or vessel.
Number of Participants With Device or Procedure-Related Events Requiring Open Cardiac Surgery or Major Endovascular Intervention Up to 12 Months Participants with device or procedure-related events requiring open cardiac surgery or major endovascular intervention will be reported.
Number of Participants Reporting Ischemic Stroke or Systemic Embolism Up to 18 Months Participant reporting ischemic stroke or systemic embolism will be reported. Systemic embolism is defined as acute vascular insufficiency or occlusion of the extremities or any non-CNS organ associated with clinical, imaging, surgical/autopsy evidence of arterial occlusion in the absence of other likely mechanism (example; trauma, atherosclerosis, or instrumentation).
- Secondary Outcome Measures
Name Time Method Number of Participants With Peri-Device Flow Up to 12 Months Peri-Device flow is defined as \>= 3 mm in width which communicates beyond the device into the body of the left atrial appendage) per transesophageal echocardiogram (TEE) evaluated by independent core laboratory.
Rate of Device-Related Thrombosis Up to 12 Months Device related thrombosis is defined as density attached to the implanted LAAC device in echocardiographic or computer tomography imaging.
Trial Locations
- Locations (127)
Grandview Medical Center
🇺🇸Birmingham, Alabama, United States
Arizona Arrhythmia Research Group Phoenix Cardio Research Group PCRG
🇺🇸Phoenix, Arizona, United States
Tucson Medical Center
🇺🇸Tucson, Arizona, United States
Arrhythmia Research Group
🇺🇸Jonesboro, Arkansas, United States
Centro Cardiologico Monzino
🇮🇹Milano, Italy
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
Stanford Health Care
🇺🇸Palo Alto, California, United States
Univeristy of California Davis Health
🇺🇸Rancho Cordova, California, United States
Scripps Health
🇺🇸San Diego, California, United States
Providence Saint John's Health Center and the Pacific Heart Institute
🇺🇸Santa Monica, California, United States
Los Robles Regional Medical Center
🇺🇸Thousand Oaks, California, United States
NCH Healthcare
🇺🇸North Naples, Florida, United States
Piedmont Healthcare
🇺🇸Atlanta, Georgia, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
The Kansas City Heart Rhythm Institute
🇺🇸Overland Park, Kansas, United States
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Northwell Health
🇺🇸Bay Shore, New York, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
NYU Heart Rhythm Center NYU Grossman School of Medicine
🇺🇸New York, New York, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Columbia University in the City of New York and The New York and Presbyterian Hospital
🇺🇸New York, New York, United States
Wake Forest University Health Sciences
🇺🇸Charlotte, North Carolina, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States
Bethesda North Hospital Trihealth
🇺🇸Cincinnati, Ohio, United States
Lindner Clinical Trial Center/Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
York Hospital
🇺🇸York, Pennsylvania, United States
TriStar Skyline Medical Center
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Texas Cardiac Arrhythmia Research Foundation
🇺🇸Austin, Texas, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Texas Heart Institute
🇺🇸Houston, Texas, United States
Baylor Scott & White Research Institute at The Heart Hospital Baylor Plano
🇺🇸Plano, Texas, United States
Heart Rhythm Associates
🇺🇸Shenandoah, Texas, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
AZORG campus Aalst Moorselbaan
🇧🇪Aalst, Belgium
AZ Sint Jan Brugge Oostende AV
🇧🇪Brugge, Belgium
C.H.U. Brugmann
🇧🇪Bruxelles, Belgium
CHU Charleroi Chimay
🇧🇪Charleroi, Belgium
Nemocnice na Homolce
🇨🇿Prague, Czechia
Rigshospitalet Copenhagen University Hospital
🇩🇰Copenhagen, Denmark
Hopital Prive Jacques Cartier
🇫🇷Massy, France
Clinique Pasteur
🇫🇷Toulouse, France
MVZ CCB Frankfurt und Main Taunus GbR
🇩🇪Frankfurt a.M., Germany
CVC CardioVascular Center Frankfurt
🇩🇪Frankfurt am Main, Germany
Asklepios Klinik St. Georg
🇩🇪Hamburg, Germany
Asklepios Klinik Altona
🇩🇪Hamburg, Germany
Fondazione Toscana Gabriele Monasterio CNR
🇮🇹Massa, Italy
ASST Grande Ospedale Metropolitano Niguarda
🇮🇹Milano, Italy
Policlinico Tor Vergata
🇮🇹Roma, Italy
Vilnius University Hospital Santaros Clinics
🇱🇹Vilnius, Lithuania
St. Antonius Ziekenhuis Nieuwegein
🇳🇱Nieuwegein, Netherlands
Erasmus MC
🇳🇱Rotterdam, Netherlands
Uniwersytecki Szpital Kliniczny w Poznaniu
🇵🇱Poznan, Poland
Hosp. de La Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Hosp Clinic de Barcelona
🇪🇸Barcelona, Spain
Hosp. Clinico San Carlos
🇪🇸Madrid, Spain
Clinica Univ. de Navarra
🇪🇸Pamplona, Spain
Hospital Universitario de Salamanca
🇪🇸Salamanca, Spain
Hosp. Alvaro Cunqueiro
🇪🇸Vigo, Spain
Grandview Medical Center
🇺🇸Birmingham, Alabama, United States
Arizona Arrhythmia Research Group Phoenix Cardio Research Group PCRG
🇺🇸Phoenix, Arizona, United States
Tucson Medical Center
🇺🇸Tucson, Arizona, United States
Arrhythmia Research Group
🇺🇸Jonesboro, Arkansas, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
Stanford Health Care
🇺🇸Palo Alto, California, United States
Univeristy of California Davis Health
🇺🇸Rancho Cordova, California, United States
Scripps Health
🇺🇸San Diego, California, United States
Providence Saint John's Health Center and the Pacific Heart Institute
🇺🇸Santa Monica, California, United States
Los Robles Regional Medical Center
🇺🇸Thousand Oaks, California, United States
NCH Healthcare
🇺🇸North Naples, Florida, United States
Piedmont Healthcare
🇺🇸Atlanta, Georgia, United States
Hosp. Clinico San Carlos
🇪🇸Madrid, Spain
Emory University
🇺🇸Atlanta, Georgia, United States
Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
The Kansas City Heart Rhythm Institute
🇺🇸Overland Park, Kansas, United States
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Northwell Health
🇺🇸Bay Shore, New York, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
NYU Heart Rhythm Center NYU Grossman School of Medicine
🇺🇸New York, New York, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Columbia University in the City of New York and The New York and Presbyterian Hospital
🇺🇸New York, New York, United States
Wake Forest University Health Sciences
🇺🇸Charlotte, North Carolina, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States
Bethesda North Hospital Trihealth
🇺🇸Cincinnati, Ohio, United States
Lindner Clinical Trial Center/Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
York Hospital
🇺🇸York, Pennsylvania, United States
TriStar Skyline Medical Center
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Texas Cardiac Arrhythmia Research Foundation
🇺🇸Austin, Texas, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Texas Heart Institute
🇺🇸Houston, Texas, United States
Baylor Scott & White Research Institute at The Heart Hospital Baylor Plano
🇺🇸Plano, Texas, United States
Heart Rhythm Associates
🇺🇸Shenandoah, Texas, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
AZORG campus Aalst Moorselbaan
🇧🇪Aalst, Belgium
AZ Sint Jan Brugge Oostende AV
🇧🇪Brugge, Belgium
C.H.U. Brugmann
🇧🇪Bruxelles, Belgium
CHU Charleroi Chimay
🇧🇪Charleroi, Belgium
Nemocnice na Homolce
🇨🇿Prague, Czechia
Rigshospitalet Copenhagen University Hospital
🇩🇰Copenhagen, Denmark
Hopital Prive Jacques Cartier
🇫🇷Massy, France
Clinique Pasteur
🇫🇷Toulouse, France
MVZ CCB Frankfurt und Main Taunus GbR
🇩🇪Frankfurt a.M., Germany
CVC CardioVascular Center Frankfurt
🇩🇪Frankfurt am Main, Germany
Asklepios Klinik St. Georg
🇩🇪Hamburg, Germany
Asklepios Klinik Altona
🇩🇪Hamburg, Germany
Fondazione Toscana Gabriele Monasterio CNR
🇮🇹Massa, Italy
Centro Cardiologico Monzino
🇮🇹Milano, Italy
ASST Grande Ospedale Metropolitano Niguarda
🇮🇹Milano, Italy
Policlinico Tor Vergata
🇮🇹Roma, Italy
Vilnius University Hospital Santaros Clinics
🇱🇹Vilnius, Lithuania
St. Antonius Ziekenhuis Nieuwegein
🇳🇱Nieuwegein, Netherlands
Erasmus MC
🇳🇱Rotterdam, Netherlands
Uniwersytecki Szpital Kliniczny w Poznaniu
🇵🇱Poznan, Poland
Hosp. de La Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Hosp Clinic de Barcelona
🇪🇸Barcelona, Spain
Clinica Univ. de Navarra
🇪🇸Pamplona, Spain
Hospital Universitario de Salamanca
🇪🇸Salamanca, Spain
Hosp. Alvaro Cunqueiro
🇪🇸Vigo, Spain