Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk
NCT ID: NCT00559988
Last Updated: 2017-12-05
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
2718 participants
INTERVENTIONAL
2008-02-29
2013-06-30
Brief Summary
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Detailed Description
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Technological advances in implanted dual-chamber cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) devices allow early detection and real time verification of AF/AFL with intracardiac electrograms (IEGM) automatically transmitted to the clinicians. Such remote diagnostic capability might be particularly relevant in patients with asymptomatic AF by allowing timely treatment. Compared to conventional periodic, (e.g., quarterly) office device evaluation, daily remote monitoring may prove superior for diagnosis of AF and prophylactic treatment of thromboembolism.
The start, stop and restart of OAC based on a predefined atrial rhythm-guided strategy in conjunction with a standard risk-stratification scheme could lead to better clinical outcomes compared with conventional clinical care. The study is designed to demonstrate a risk reduction of both thromboembolism proximate to episodes of documented AF/AFL and bleeding potentiated by chronic OAC in the absence of AF. Verification of this premise would impact the clinical practice, providing evidence to physicians for the use of HM to guide OAC in patients with AF/AFL. The results of this study should demonstrate the clinical value of wireless remote surveillance of the cardiac rhythm and may define the critical threshold of AF/AFL burden warranting OAC or antiarrhythmic drug therapy in patients at risk of stroke
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Home Monitoring Guided OAC
Home Monitoring is fully enabled and continuous remote surveillance data is available to investigators. Patients will be treated according to a predefined anticoagulation plan, which uses the total duration of AF/AFL combined with patients' CHADS2 score to determine the start, stop, and restart of OAC.
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
In Control (Group 2), Home Monitoring is active for Safety Net alerts, but the remote AF/AFL data is not revealed to the patient or treating physician. These patients receive physician-directed OAC consistent with current standards of care.
Safety Net data include:
* ERI/EOS
* Special Implant Status
* Implant in Backup Mode (ROM)
* VT/ VF Detection Inactive
* Emergency Pacing
* 250 Ω \> RV Pacing Impedance \> 1500 Ω
* Symptomatic VT/VF therapies including both ATP and shock
* VT/VF storm
* HM transmission failure \>3 days
Physician-Directed OAC
Patients will receive physician-directed anticoagulation therapy based on conventional criteria.
OAC drugs used: Dabigatran etexilate, Rivaroxaban, Warfarin, other approved VKA
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Documented P wave mean amplitude ≥ 1.0 mV (sinus rhythm) or ≥ 0.5 mV (AF) at enrollment, if previously implanted
* CHADS2 risk score ≥ 1
* Able and willing to follow OAC therapy if the indication develops during the course of the trial
* Able to utilize the HM throughout the study
Exclusion Criteria
* History of stroke, transient ischemic attack (TIA) or systemic embolism and documented AF or AFL
* Currently requiring OAC therapy for any indication
* Patients who underwent successful AF ablation (sinus rhythm restored) and have not completed a minimum of 3 months of OAC therapy
* Known, current contraindication to use of eligible OAC
* Long QT or Brugada syndrome as the sole indication for device implantation
* Life expectancy less than the expected term of the study
18 Years
ALL
No
Sponsors
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Biotronik, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jonathan L Halperin, M.D.
Role: STUDY_CHAIR
Mount Sinai Medical Center, New York, NY
John Ip, M.D.
Role: STUDY_CHAIR
Thoracic & Cardiovascular Healthcare Foundation, Lansing, MI
Locations
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Ridgewood, New Jersey, United States
New York, New York, United States
Durham, North Carolina, United States
Hickory, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Kettering, Ohio, United States
Middletown, Ohio, United States
Toledo, Ohio, United States
Westlake, Ohio, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Tualatin, Oregon, United States
Abington, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Phoenixville, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Greenville, South Carolina, United States
Rock Hill, South Carolina, United States
Cookeville, Tennessee, United States
Germantown, Tennessee, United States
Nashville, Tennessee, United States
Corpus Christi, Texas, United States
Houston, Texas, United States
Humble, Texas, United States
Kingwood, Texas, United States
Wahroonga, , Australia
Montreal, Quebec, Canada
Sherbrooke, Quebec, Canada
Aarhus, , Denmark
Tübingen, , Germany
Villingen, , Germany
Birmingham, , United Kingdom
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Anaheim, California, United States
Fremont, California, United States
Santa Barbara, California, United States
Torrance, California, United States
Ventura, California, United States
Aurora, Colorado, United States
Boulder, Colorado, United States
Newark, Delaware, United States
Davenport, Florida, United States
Daytona Beach, Florida, United States
Kissimmee, Florida, United States
Melbourne, Florida, United States
Sarasota, Florida, United States
St. Petersburg, Florida, United States
Zephyrhills, Florida, United States
Chicago, Illinois, United States
Elk Grove Village, Illinois, United States
Maywood, Illinois, United States
Fort Wayne, Indiana, United States
Valparaiso, Indiana, United States
Shawnee Mission, Kansas, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Owensboro, Kentucky, United States
Hammond, Louisiana, United States
Lafayette, Louisiana, United States
New Orleans, Louisiana, United States
Bangor, Maine, United States
Lewiston, Maine, United States
Cumberland, Maryland, United States
Boston, Massachusetts, United States
Burlington, Massachusetts, United States
Worcester, Massachusetts, United States
Ann Arbor, Michigan, United States
Bay City, Michigan, United States
Lansing, Michigan, United States
Lapeer, Michigan, United States
Saginaw, Michigan, United States
Ypsilanti, Michigan, United States
Minneapolis, Minnesota, United States
Tupelo, Mississippi, United States
Kansas City, Missouri, United States
Osage Beach, Missouri, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Countries
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References
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Martin DT, Bersohn MM, Waldo AL, Wathen MS, Choucair WK, Lip GY, Ip J, Holcomb R, Akar JG, Halperin JL; IMPACT Investigators. Randomized trial of atrial arrhythmia monitoring to guide anticoagulation in patients with implanted defibrillator and cardiac resynchronization devices. Eur Heart J. 2015 Jul 7;36(26):1660-8. doi: 10.1093/eurheartj/ehv115. Epub 2015 Apr 23.
Other Identifiers
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IMPACT
Identifier Type: -
Identifier Source: org_study_id