Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk (IMPACT)
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ClinicalTrials.gov Identifier: NCT00559988 |
Recruitment Status
:
Terminated
First Posted
: November 19, 2007
Results First Posted
: June 23, 2014
Last Update Posted
: December 5, 2017
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Tracking Information | |||||||
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First Submitted Date ICMJE | November 15, 2007 | ||||||
First Posted Date ICMJE | November 19, 2007 | ||||||
Results First Submitted Date | May 20, 2014 | ||||||
Results First Posted Date | June 23, 2014 | ||||||
Last Update Posted Date | December 5, 2017 | ||||||
Study Start Date ICMJE | February 2008 | ||||||
Actual Primary Completion Date | June 2013 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Composite Primary Endpoint: Kaplan-Meier Estimate of Patients Without a Stroke, Systemic Embolism, or Major Bleed [ Time Frame: From date of enrollment until date of primary endpoint event, assessed up to study exit, with a mean treatment duration of 2.0 years ] 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.
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Original Primary Outcome Measures ICMJE |
The study hypothesis states that early detection of AF/AFL based on BIOTRONIK HM technology combined with a predefined anticoagulation plan will reduce the rate of the composite endpoint of stroke, systemic embolism and major bleeding. [ Time Frame: 3 years ] | ||||||
Change History | Complete list of historical versions of study NCT00559988 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Rates of All-cause Mortality, Stroke (Ischemic and Hemorrhagic, Disabling and Non-disabling, Cardioembolic and Non-cardioembolic), and Major Bleeding, as Well as the AF Burden, Quality of Life, and Mean Heart Rate Reduction. [ Time Frame: 3 years ] | ||||||
Current Other Outcome Measures ICMJE | Not Provided | ||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk | ||||||
Official Title ICMJE | The IMPACT of BIOTRONIK Home Monitoring Guided Anticoagulation on Stroke Risk in Patients With ICD and CRT-D Devices | ||||||
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. | ||||||
Detailed Description | Atrial fibrillation (AF) and atrial flutter (AFL) are common cardiac arrhythmias associated with an increased incidence of stroke in patients with additional risk factors. Oral Anticoagulation (OAC) reduces stroke risk, but because these arrhythmias are frequently intermittent and asymptomatic, start of OAC therapy is often delayed until electrocardiographic documentation is obtained. 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 |
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Study Type ICMJE | Interventional | ||||||
Study Phase | Phase 4 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Investigator) Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * | 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. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Terminated | ||||||
Actual Enrollment ICMJE |
2718 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Actual Study Completion Date | June 2013 | ||||||
Actual Primary Completion Date | June 2013 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Key Inclusion Criteria:
Key Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Australia, Canada, Denmark, Germany, United Kingdom, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00559988 | ||||||
Other Study ID Numbers ICMJE | IMPACT | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Biotronik, Inc. | ||||||
Study Sponsor ICMJE | Biotronik, Inc. | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Biotronik, Inc. | ||||||
Verification Date | November 2017 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |