Heart plug vs. blood thinners: major trial tests best way to stop strokes

NCT ID NCT04226547

Ongoing Disease control Sponsor: Abbott Medical Devices Source: ClinicalTrials.gov ↗

Summary

This large study is testing whether a small device implanted in the heart is as good as, or better than, daily blood thinner pills for preventing strokes in people with a common heart rhythm problem called atrial fibrillation. About 2,650 participants at high risk for stroke were randomly assigned to receive either the implant or take standard blood thinner medication. The main goal is to see if the device can prevent strokes as effectively as the pills while potentially causing fewer serious bleeding problems.

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes NO responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

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Locations

AdventHealth Florida Cardiology - Altamonte Springs

Altamonte Springs, Florida, 32701, United States
AdventHealth Florida Cardiology - Lake Mary

Lake Mary, Florida, 32746, United States
AdventHealth Florida Cardiology - Oviedo

Oviedo, Florida, 32765, United States
AdventHealth Orlando

Orlando, Florida, 32803, United States
Arizona Cardiovascular Research Center

Phoenix, Arizona, 85016, United States
Arrhythmia Research Group

Jonesboro, Arkansas, 72401, United States
Baptist Health Lexington

Lexington, Kentucky, 40503, United States
Baptist Medical Center

Jacksonville, Florida, 32207, United States
Baylor All Saints Medical Center at Fort Worth

Forth Worth, Texas, 76104, United States
Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States
Bryan Heart

Lincoln, Nebraska, 68506, United States
Buffalo General Hospital

Buffalo, New York, 14203, United States
CHI Health Creighton University Medical Center-Bergan Mercy

Omaha, Nebraska, 68124, United States
CHI St. Luke's Health Baylor College of Medicine Med. Ctr.

Houston, Texas, 77030, United States
CHU Gabriel Montpied

Clermont-Ferrand, 63003, France
CHUM

Montreal, H2X 3E4, Canada
Cardioangiologisches Centrum am Bethanien Krankenhaus

Frankfurt, 60389, Germany
Cardiovascular Institute of the South

Houma, Louisiana, 70361, United States
Center Inselspital Bern

Bern, 3010, Switzerland
Central DuPage Hospital

Winfield, Illinois, 60190, United States
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

Lodz, 92-213, Poland
Chiba University

Chiba, Chiba, 260-8677, Japan
Cooper University Hospital

Camden, New Jersey, 08103, United States
Emory University Hospital

Atlanta, Georgia, 30322, United States
Erlanger Medical Center

Chattanooga, Tennessee, 37403, United States
Fakultni nemocnice Kralovske Vinohrady

Prague, 100 34, Czechia
Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia
Fondazione Toscana Gabriele Monasterio

Massa, 54100, Italy
Heart Center Research, LLC

Huntsville, Alabama, 35801, United States
Heart Rhythm Associates

Shenandoah, Texas, 77380, United States
Helios Klinikum Siegburg

Siegburg, 53721, Germany
Hightower Clinical

Oklahoma City, Oklahoma, 73102, United States
Hopital Haut Leveque

Pessac, 33604, France
Hospital Clinic I Provincial de Barcelona

Barcelona, 08036, Spain
Hospital Clinico San Carlos

Madrid, Madrid, Spain
Hospital Universitario de Salamanca

Salamanca, 37007, Spain
Hospital de la Santa Creu I Sant Pau

Barcelona, 08025, Spain
Huntington Memorial Hospital

Pasadena, California, 91109, United States
Institut de Cardiologie de Montreal (Montreal Heart Inst.)

Montreal, H1T 1C8, Canada
Institute Cardio. Paris-Sud - Institut Jacques Cartier

Massy, 91300, France
Institute of Science Tokyo Hospital

Tokyo, Tokyo, 113-8519, Japan
Internistisches Klinikum München SUD

Munich, 81379, Germany
Jackson Heart Clinic

Jackson, Mississippi, 39216, United States
Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States
Kansas City Cardiac Arrhythmia Research Foundation

Overland Park, Kansas, 66211, United States
Kansas University Medical Center

Kansas City, Kansas, 66160, United States
Klinikum der Justus-Liebig-Universität

Giessen, 35392, Germany
Kokura Memorial Hospital

Kitakyushu, Fukuoka, 802-8555, Japan
Kurashiki Central Hospital

Kurashiki-shi, Okayama-ken, Japan
Lutheran Hospital of Indiana

Fort Wayne, Indiana, 46801, United States
MedStar Union Memorial Hospital

Baltimore, Maryland, 21218, United States
MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States
Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States
Memorial Hermann Hospital

Houston, Texas, 77030, United States
Memorial Katy Cardiology Associates

Houston, Texas, 77094, United States
Mercy Medical Group - Cardiology

Sacramento, California, 95819, United States
Methodist Texsan Hospital

San Antonio, Texas, 78201, United States
Mission Health & Hospitals

Asheville, North Carolina, 28801, United States
Monongalia General Hospital

Morgantown, West Virginia, 26505, United States
Mount Sinai Hospital

New York, New York, 10019, United States
Mutualiste Montsouris

Paris, 75014, France
NC Heart & Vascular Research

Raleigh, North Carolina, 27607, United States
NCH Healthcare System

Naples, Florida, 34102, United States
Nemocnice Na Homolce

Prague, 150 30, Czechia
New Mexico Heart Institute

Albuquerque, New Mexico, 87102, United States
New York Presbyterian Hospital/Cornell University

New York, New York, 10021, United States
Northside Hospital

Atlanta, Georgia, 30342, United States
Northside Hospital (CardioVascular Group Lawrenceville)

Lawrenceville, Georgia, 30045, United States
Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States
Oklahoma Heart Institute at Utica

Tulsa, Oklahoma, 74104, United States
Ospedale San Raffaele

Milan, 20132, Italy
Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada
Our Lady of the Lake Physician Group

Baton Rouge, Louisiana, 70808, United States
Overland Park Mid America Cardiology

Overland Park, Kansas, 66211, United States
Park Plaza Hospital

Houston, Texas, 77004, United States
Piedmont Heart Institute

Atlanta, Georgia, 30309, United States
Pinnacle Health System

Harrisburg, Pennsylvania, 17105, United States
Prince of Wales Hospital

Hong Kong, 999077, Hong Kong
Queen Elizabeth Hospital

Hong Kong, Hong Kong
Rigshospitalet

Copenhagen, 2100, Denmark
Roper Hospital

Charleston, South Carolina, 29401, United States
Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia
Sanford USD Medical Center

Sioux Falls, South Dakota, 57117, United States
Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States
Scripps Health

La Jolla, California, 92037, United States
Segeberger Kliniken GmbH

Bad Segeberg, 23795, Germany
Sendai Kousei Hospital

Sendai, Miyagi, 980-0973, Japan
Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States
Shonan Kamakura General Hospital

Kamakura, Kanagawa, 247-8533, Japan
Skejby University Hospital

Aarhus, 8200, Denmark
Slaskie Centrum Chorob Serca

Zabrze, 41-800, Poland
South Denver Cardiology Associates PC

Littleton, Colorado, 80120, United States
South Shore University Hospital-Northwell

Bay Shore, New York, 11706, United States
Spectrum Health Butterworth Hospital

Grand Rapids, Michigan, 49503, United States
St. Antonius Ziekenhuis

Nieuwegein, 3435 CM, Netherlands
St. Cloud Hospital - Central MN Heart Clinic

Saint Cloud, Minnesota, 56303, United States
St. Joseph's Hospital

Atlanta, Georgia, 30342, United States
St. Marien-Hospital-Bonn

Bonn, 53115, Germany
St. Vincent Hospital

Indianapolis, Indiana, 46240, United States
St. Vincent's Medical Center

Jacksonville, Florida, 32204, United States
Stadtspital Triemli

Zurich, 8063, Switzerland
Staten Island University Hospital Northwell

Staten Island, New York, 10305, United States
Tennova Healthcare-Turkey Creek Medical Center

Knoxville, Tennessee, 37920, United States
Texas Cardiac Arrhythmia

Austin, Texas, 78705, United States
The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States
The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States
The Methodist Hospital

Houston, Texas, 77030, United States
The Royal Sussex County Hospital

Brighton, BN25BE, United Kingdom
The University of Hong Kong (Queen Mary Hospital)

Hong Kong, Hong Kong
Toho University Ohashi Medical Center

Meguro-ku, Tokyo, 153-8515, Japan
Toyohashi Heart Center

Toyohashi, Aichi-ken, 441-8530, Japan
TriHealth Bethesda North Hospital

Cincinnati, Ohio, 45242, United States
Tucson Medical Center

Tucson, Arizona, 85712, United States
Tufts Medical Center

Boston, Massachusetts, 02111, United States
UAMS Medical Center

Little Rock, Arkansas, 72205, United States
University Hospital - Univ. of Alabama at Birmingham (UAB)

Birmingham, Alabama, 35249, United States
University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States
University of Tsukuba Hospital

Tsukuba, Ibaraki, 305-8576, Japan
Universitätsklinikum Schleswig-Holstein - Campus Lübeck

Lübeck, Schleswig-Holstein, 23562, Germany
Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)

Berlin, Brandenburg, 12203, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, 55131, Germany
VA Medical Center Minneapolis

Minneapolis, Minnesota, 55417, United States
Vancouver General Hospital (U of BC)

Vancouver, V5Z 1M9, Canada
Vanderbilt Heart & Vascular Institute

Nashville, Tennessee, 37232, United States
Via Christi Regional Medical Center - St. Francis Campus

Wichita, Kansas, 67214, United States
Vilnius University Hospital Santariskiu Klinikos

Vilnius, 08661, Lithuania
WellSpan Health

York, Pennsylvania, 17403, United States

Conditions

Explore the condition pages connected to this study.

ATRIAL FIBRILLATION BLEEDING STROKE