Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk
IMPACT
The IMPACT of BIOTRONIK Home Monitoring Guided Anticoagulation on Stroke Risk in Patients With ICD and CRT-D Devices
1 other identifier
interventional
2,718
6 countries
80
Brief Summary
The IMPACT Study will investigate the potential clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) technology and a predefined anticoagulation plan compared to conventional device evaluation and physician-directed anticoagulation in patients with implanted dual-chamber defibrillators or cardiac resynchronization therapy devices.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 atrial-fibrillation
Started Feb 2008
Longer than P75 for phase_4 atrial-fibrillation
80 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2007
CompletedFirst Posted
Study publicly available on registry
November 19, 2007
CompletedStudy Start
First participant enrolled
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
June 23, 2014
CompletedDecember 5, 2017
November 1, 2017
5.3 years
November 15, 2007
May 20, 2014
November 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite Primary Endpoint: Kaplan-Meier Estimate of Patients Without a Stroke, Systemic Embolism, or Major Bleed
The primary endpoint is to demonstrate whether early detection of atrial arrhythmias based on BIOTRONIK Home Monitoring technology combined with a predefined anticoagulation plan in the Home Monitoring Guided OAC group is superior to the Physician-Directed OAC group reflecting conventional care and physician directed treatment of AF in terms of risk reduction of the primary composite endpoint including stroke, systemic embolism, and major bleeding events.
From date of enrollment until date of primary endpoint event, assessed up to study exit, with a mean treatment duration of 2.0 years
Secondary Outcomes (8)
Rates of All-cause Mortality
Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years
Rate of Ischemic and Hemorrhagic Stroke
Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years
Rate of Fatal or Disabling and Non-disabling Stroke
Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years
Rate of Major Bleeding Events
Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years
Mean Atrial Fibrillation/Atrial Flutter Burden
Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years
- +3 more secondary outcomes
Study Arms (2)
Home Monitoring Guided OAC
EXPERIMENTALHome 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.
Physician-Directed OAC
ACTIVE COMPARATORIn 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
Interventions
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
Patients will receive physician-directed anticoagulation therapy based on conventional criteria. OAC drugs used: Dabigatran etexilate, Rivaroxaban, Warfarin, other approved VKA
Eligibility Criteria
You may qualify if:
- Candidates for implantation of, or already implanted with, a BIOTRONIK Lumax HF-T or DR-T device
- 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
You may not qualify if:
- Permanent AF
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biotronik, Inc.lead
Study Sites (80)
Unknown Facility
Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Anaheim, California, United States
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Fremont, California, United States
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Santa Barbara, California, United States
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Torrance, California, United States
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Ventura, California, United States
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Aurora, Colorado, United States
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Boulder, Colorado, United States
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Newark, Delaware, United States
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Davenport, Florida, United States
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Daytona Beach, Florida, United States
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Kissimmee, Florida, United States
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Melbourne, Florida, United States
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Sarasota, Florida, United States
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St. Petersburg, Florida, United States
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Zephyrhills, Florida, United States
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Chicago, Illinois, United States
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Elk Grove Village, Illinois, United States
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Maywood, Illinois, United States
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Fort Wayne, Indiana, United States
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Valparaiso, Indiana, United States
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Shawnee Mission, Kansas, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Owensboro, Kentucky, United States
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Hammond, Louisiana, United States
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Lafayette, Louisiana, United States
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New Orleans, Louisiana, United States
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Bangor, Maine, United States
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Lewiston, Maine, United States
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Cumberland, Maryland, United States
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Boston, Massachusetts, United States
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Burlington, Massachusetts, United States
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Worcester, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Bay City, Michigan, United States
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Lansing, Michigan, United States
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Lapeer, Michigan, United States
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Saginaw, Michigan, United States
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Ypsilanti, Michigan, United States
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Minneapolis, Minnesota, United States
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Tupelo, Mississippi, United States
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Kansas City, Missouri, United States
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Osage Beach, Missouri, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Ridgewood, New Jersey, United States
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New York, New York, United States
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Durham, North Carolina, United States
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Hickory, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Kettering, Ohio, United States
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Middletown, Ohio, United States
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Toledo, Ohio, United States
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Westlake, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Tualatin, Oregon, United States
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Abington, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Phoenixville, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Greenville, South Carolina, United States
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Rock Hill, South Carolina, United States
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Cookeville, Tennessee, United States
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Germantown, Tennessee, United States
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Nashville, Tennessee, United States
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Corpus Christi, Texas, United States
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Houston, Texas, United States
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Humble, Texas, United States
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Kingwood, Texas, United States
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Wahroonga, Australia
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Montreal, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Aarhus, Denmark
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Tübingen, Germany
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Villingen, Germany
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Birmingham, United Kingdom
Related Publications (1)
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.
PMID: 25908774DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Study stopped early when primary endpoint met futility criteria. Continuation may have changed the outcome; however, unlikely to demonstrate a meaningful clinical benefit. Interpretation of secondary endpoints should be approached with caution.
Results Point of Contact
- Title
- Crystal Miller
- Organization
- Biotronik, Inc
Study Officials
- STUDY CHAIR
Jonathan L Halperin, M.D.
Mount Sinai Medical Center, New York, NY
- STUDY CHAIR
John Ip, M.D.
Thoracic & Cardiovascular Healthcare Foundation, Lansing, MI
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2007
First Posted
November 19, 2007
Study Start
February 1, 2008
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
December 5, 2017
Results First Posted
June 23, 2014
Record last verified: 2017-11