Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk

PHASE4TerminatedINTERVENTIONAL
Enrollment

2,718

Participants

Timeline

Start Date

February 29, 2008

Primary Completion Date

June 30, 2013

Study Completion Date

June 30, 2013

Conditions
Atrial FibrillationAtrial FlutterStrokeEmbolism, Systemic ArterialMajor Bleeding
Interventions
DRUG

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"

DRUG

Physician-Directed OAC

"Patients will receive physician-directed anticoagulation therapy based on conventional criteria.~OAC drugs used: Dabigatran etexilate, Rivaroxaban, Warfarin, other approved VKA"

Trial Locations (80)

Unknown

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

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Biotronik, Inc.

INDUSTRY