2,718
Participants
Start Date
February 29, 2008
Primary Completion Date
June 30, 2013
Study Completion Date
June 30, 2013
Home Monitoring Guided OAC
"Active monitoring for atrial episodes through the automatic HM notifications (email, fax, short message service) is required. If the total duration over 48 consecutive hours reaches the predefined anticoagulation condition, and AF/AFL diagnosis is confirmed using the IEGM online, the site instructs the patient by telephone to start OAC. Clinicians continue to monitor patients using HM, and if freedom from AF/AFL reaches the predefined interval, stop of OAC therapy is requested over the telephone. Following stop of anticoagulation, any recurrence of AF/AFL requires restart of OAC therapy.~OAC drugs used: Dabigatran etexilate, Rivaroxaban, Warfarin, other approved VKA"
Physician-Directed OAC
"Patients will receive physician-directed anticoagulation therapy based on conventional criteria.~OAC drugs used: Dabigatran etexilate, Rivaroxaban, Warfarin, other approved VKA"
Phoenix
Scottsdale
Anaheim
Fremont
Santa Barbara
Torrance
Ventura
Aurora
Boulder
Newark
Davenport
Daytona Beach
Kissimmee
Melbourne
Sarasota
St. Petersburg
Zephyrhills
Chicago
Elk Grove Village
Maywood
Fort Wayne
Valparaiso
Shawnee Mission
Lexington
Louisville
Owensboro
Hammond
Lafayette
New Orleans
Bangor
Lewiston
Cumberland
Boston
Burlington
Worcester
Ann Arbor
Bay City
Lansing
Lapeer
Saginaw
Ypsilanti
Minneapolis
Tupelo
Kansas City
Osage Beach
St Louis
Omaha
Ridgewood
New York
Durham
Hickory
Cincinnati
Cleveland
Kettering
Middletown
Toledo
Westlake
Oklahoma City
Tulsa
Tualatin
Abington
Philadelphia
Phoenixville
Pittsburgh
Greenville
Rock Hill
Cookeville
Germantown
Nashville
Corpus Christi
Houston
Humble
Kingwood
Wahroonga
Montreal
Sherbrooke
Aarhus
Tübingen
Villingen
Birmingham
Lead Sponsor
Biotronik, Inc.
INDUSTRY