Clinical Trial of Atrial Fibrillation Patients Comparing Left Atrial Appendage Occlusion Therapy to Non-vitamin K Antagonist Oral Anticoagulants

Status: Recruiting
Location: See all (130) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy. The clinical investigation is a prospective, randomized, multicenter active control worldwide trial. Subjects will be randomized in a 1:1 ratio between the Amulet LAA occlusion device (Device Group) and a commercially available NOAC medication (Control Group). The choice of NOAC in the Control Group will be left to study physician discretion.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Documented paroxysmal, persistent, or permanent non-valvular AF (documentation must include an electrocardiogram, Holter, or event recorder)

• At high risk of stroke or systemic embolism, defined as a CHA2DS2-VASc score of ≥ 2 for men and ≥ 3 for women

• Eligible for long-term NOAC therapy

• Able to comply with the required NOAC medication regimen if randomized to the Control Group

• Able to comply with the required medication regimen post-device implant if subject is randomized to the Device Group or subject is a Roll-in

• Able to understand, and is willing to provide, written informed consent to participate in the trial, prior to any clinical investigation related procedure or assessment

• 18 years of age or older, or the age of legal consent

• Able and willing to return for required follow-up visits and assessments

Locations
United States
Alabama
University Hospital - Univ. of Alabama at Birmingham (UAB)
RECRUITING
Birmingham
Heart Center Research, LLC
RECRUITING
Huntsville
Arkansas
Arrhythmia Research Group
RECRUITING
Jonesboro
UAMS Medical Center
ACTIVE_NOT_RECRUITING
Little Rock
Arizona
Arizona Cardiovascular Research Center
RECRUITING
Phoenix
Tucson Medical Center
RECRUITING
Tucson
California
Scripps Health
RECRUITING
La Jolla
Kaiser Permanente Los Angeles Medical Center
RECRUITING
Los Angeles
Huntington Memorial Hospital
RECRUITING
Pasadena
Mercy Medical Group - Cardiology
RECRUITING
Sacramento
University of California at San Diego (UCSD) Medical Center
WITHDRAWN
San Diego
Colorado
South Denver Cardiology Associates PC
ACTIVE_NOT_RECRUITING
Littleton
Washington, D.c.
MedStar Washington Hospital Center
RECRUITING
Washington D.c.
Florida
AdventHealth Florida Cardiology - Altamonte Springs
RECRUITING
Altamonte Springs
Baptist Medical Center
RECRUITING
Jacksonville
St. Vincent's Medical Center
RECRUITING
Jacksonville
AdventHealth Florida Cardiology - Lake Mary
RECRUITING
Lake Mary
NCH Healthcare System
RECRUITING
Naples
AdventHealth Orlando
RECRUITING
Orlando
AdventHealth Florida Cardiology - Oviedo
RECRUITING
Oviedo
Sarasota Memorial Hospital
RECRUITING
Sarasota
Georgia
Emory University Hospital
RECRUITING
Atlanta
Northside Hospital
RECRUITING
Atlanta
Piedmont Heart Institute
RECRUITING
Atlanta
St. Joseph's Hospital
RECRUITING
Atlanta
Northside Hospital (CardioVascular Group Lawrenceville)
RECRUITING
Lawrenceville
Illinois
Northwestern Memorial Hospital
RECRUITING
Chicago
Rush University Medical Center
WITHDRAWN
Chicago
Central DuPage Hospital
RECRUITING
Winfield
Indiana
Lutheran Hospital of Indiana
RECRUITING
Fort Wayne
St. Vincent Hospital
ACTIVE_NOT_RECRUITING
Indianapolis
Kansas
Kansas University Medical Center
RECRUITING
Kansas City
Kansas City Cardiac Arrhythmia Research Foundation
RECRUITING
Overland Park
Overland Park Mid America Cardiology
RECRUITING
Overland Park
Via Christi Regional Medical Center - St. Francis Campus
RECRUITING
Wichita
Kentucky
Baptist Health Lexington
RECRUITING
Lexington
Louisiana
Our Lady of the Lake Physician Group
RECRUITING
Baton Rouge
Cardiovascular Institute of the South
RECRUITING
Houma
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Tufts Medical Center
RECRUITING
Boston
Maryland
MedStar Union Memorial Hospital
RECRUITING
Baltimore
Michigan
Spectrum Health Butterworth Hospital
RECRUITING
Grand Rapids
Minnesota
VA Medical Center Minneapolis
RECRUITING
Minneapolis
St. Cloud Hospital - Central MN Heart Clinic
RECRUITING
Saint Cloud
Mississippi
Jackson Heart Clinic
RECRUITING
Jackson
North Carolina
Mission Health & Hospitals
RECRUITING
Asheville
NC Heart & Vascular Research
RECRUITING
Raleigh
Nebraska
Bryan Heart
RECRUITING
Lincoln
CHI Health Creighton University Medical Center-Bergan Mercy
RECRUITING
Omaha
New Jersey
Cooper University Hospital
RECRUITING
Camden
New Mexico
New Mexico Heart Institute
RECRUITING
Albuquerque
New York
South Shore University Hospital-Northwell
RECRUITING
Bay Shore
Buffalo General Hospital
RECRUITING
Buffalo
Mount Sinai Hospital
RECRUITING
New York
New York Presbyterian Hospital/Cornell University
RECRUITING
New York
Staten Island University Hospital Northwell
RECRUITING
Staten Island
Ohio
TriHealth Bethesda North Hospital
RECRUITING
Cincinnati
The Cleveland Clinic Foundation
RECRUITING
Cleveland
Oklahoma
Hightower Clinical
RECRUITING
Oklahoma City
Integris Baptist Medical Center
WITHDRAWN
Oklahoma City
Oklahoma Heart Institute at Utica
RECRUITING
Tulsa
Pennsylvania
Pinnacle Health System
RECRUITING
Harrisburg
University of Pittsburgh Medical Center
RECRUITING
Pittsburgh
WellSpan Health
RECRUITING
York
South Carolina
Roper Hospital
RECRUITING
Charleston
South Dakota
Sanford USD Medical Center
RECRUITING
Sioux Falls
Tennessee
Erlanger Medical Center
RECRUITING
Chattanooga
Tennova Healthcare-Turkey Creek Medical Center
RECRUITING
Knoxville
Vanderbilt Heart & Vascular Institute
RECRUITING
Nashville
Texas
Texas Cardiac Arrhythmia
RECRUITING
Austin
Baylor All Saints Medical Center at Fort Worth
RECRUITING
Forth Worth
CHI St. Luke's Health Baylor College of Medicine Med. Ctr.
ACTIVE_NOT_RECRUITING
Houston
Memorial Hermann Hospital
RECRUITING
Houston
Memorial Katy Cardiology Associates
RECRUITING
Houston
Park Plaza Hospital
RECRUITING
Houston
The Methodist Hospital
RECRUITING
Houston
The Heart Hospital Baylor Plano
RECRUITING
Plano
Methodist Texsan Hospital
RECRUITING
San Antonio
Heart Rhythm Associates
RECRUITING
Shenandoah
Virginia
Sentara Norfolk General Hospital
RECRUITING
Norfolk
Wisconsin
Medical College of Wisconsin
RECRUITING
Milwaukee
West Virginia
Monongalia General Hospital
RECRUITING
Morgantown
Other Locations
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
Fiona Stanley Hospital
RECRUITING
Murdoch
Royal Melbourne Hospital - City Campus
WITHDRAWN
Parkville
Canada
CHUM
RECRUITING
Montreal
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
RECRUITING
Montreal
Ottawa Heart Institute
RECRUITING
Ottawa
Vancouver General Hospital (U of BC)
RECRUITING
Vancouver
Denmark
Skejby University Hospital
RECRUITING
Aarhus
Rigshospitalet
RECRUITING
Copenhagen
France
CHU Gabriel Montpied
COMPLETED
Clermont-ferrand
Hopital Henri Mondor
WITHDRAWN
Créteil
Institute Cardio. Paris-Sud - Institut Jacques Cartier
RECRUITING
Massy
Mutualiste Montsouris
RECRUITING
Paris
Hopital Haut Leveque
RECRUITING
Pessac
Germany
Segeberger Kliniken GmbH
ACTIVE_NOT_RECRUITING
Bad Segeberg
Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)
RECRUITING
Berlin
St. Marien-Hospital-Bonn
RECRUITING
Bonn
Cardioangiologisches Centrum am Bethanien Krankenhaus
RECRUITING
Frankfurt
Klinikum der Justus-Liebig-Universität
RECRUITING
Giessen
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
RECRUITING
Lübeck
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
RECRUITING
Mainz
Internistisches Klinikum München SUD
RECRUITING
Munich
Helios Klinikum Siegburg
ACTIVE_NOT_RECRUITING
Siegburg
Hong Kong Special Administrative Region
Prince of Wales Hospital
RECRUITING
Hong Kong
Queen Elizabeth Hospital
RECRUITING
Hong Kong
The University of Hong Kong (Queen Mary Hospital)
RECRUITING
Hong Kong
Italy
Fondazione Toscana Gabriele Monasterio
RECRUITING
Massa
Ospedale San Raffaele
ACTIVE_NOT_RECRUITING
Milan
Japan
Chiba University
ACTIVE_NOT_RECRUITING
Chiba
Shonan Kamakura General Hospital
ACTIVE_NOT_RECRUITING
Kamakura
Kokura Memorial Hospital
ACTIVE_NOT_RECRUITING
Kitakyushu
Kurashiki Central Hospital
ACTIVE_NOT_RECRUITING
Kurashiki-shi
Toho University Ohashi Medical Center
ACTIVE_NOT_RECRUITING
Meguro-ku
Sendai Kousei Hospital
ACTIVE_NOT_RECRUITING
Sendai
Institute of Science Tokyo Hospital
ACTIVE_NOT_RECRUITING
Tokyo
Toyohashi Heart Center
ACTIVE_NOT_RECRUITING
Toyohashi
University of Tsukuba Hospital
ACTIVE_NOT_RECRUITING
Tsukuba
Lithuania
Vilnius University Hospital Santariskiu Klinikos
RECRUITING
Vilnius
Netherlands
St. Antonius Ziekenhuis
RECRUITING
Nieuwegein
Poland
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
RECRUITING
Lodz
Slaskie Centrum Chorob Serca
RECRUITING
Zabrze
Spain
Hospital Clinic I Provincial de Barcelona
RECRUITING
Barcelona
Hospital de la Santa Creu I Sant Pau
RECRUITING
Barcelona
Hospital Clinico San Carlos
RECRUITING
Madrid
Hospital Universitario de Salamanca
RECRUITING
Salamanca
Switzerland
Center Inselspital Bern
RECRUITING
Bern
Stadtspital Triemli
RECRUITING
Zurich
United Kingdom
The Royal Sussex County Hospital
RECRUITING
Brighton
Contact Information
Primary
CATALYST Study Team
catalyststudy@abbott.com
(408) 845-0536
Time Frame
Start Date: 2020-07-07
Estimated Completion Date: 2030-08
Participants
Target number of participants: 2650
Treatments
Experimental: Device Group
Randomized to Amplatzer Amulet LAA occluder
Active_comparator: Control Group
Randomized to NOAC
Related Therapeutic Areas
Sponsors
Leads: Abbott Medical Devices

This content was sourced from clinicaltrials.gov