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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
Sponsor:
Information provided by (Responsible Party):
Biotronik, Inc.

Tracking Information
First Submitted Date  ICMJE November 15, 2007
First Posted Date  ICMJE November 19, 2007
Results First Submitted Date  ICMJE May 20, 2014
Results First Posted Date  ICMJE 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
 (submitted: June 23, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 15, 2007)
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
 (submitted: November 1, 2017)
  • Rates of All-cause Mortality [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years ]
  • Rate of Major Bleeding Events [ Time Frame: 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 [ Time Frame: Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years ]
  • Rate of Cardioembolic and Non-cardioembolic Stroke [ Time Frame: Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years ]
  • Change in Quality of Life Score [ Time Frame: 1 year ]
    Quality of Life was evaluated using the SF-36 v2 Health Survey. The SF-36 consists of eight scaled scores which correspond to the following sections: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are recoded per a scoring key with each question having a value from 0 to 100. Scores from items in the same scale are averaged together per the scoring key to create the section and subsection (physical health and mental health) scores. For all reported scores, the lowest possible value is 0 (representing the highest disability) and the highest possible value is 100 (representing no disability). Therefore, a positive change from baseline to 1 year represents an improvement in disability, while a negative change represents a worsening of disability.
  • Mean Ventricular Heart Rate Reduction [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2007)
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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Atrial Fibrillation
  • Atrial Flutter
  • Stroke
  • Embolism, Systemic Arterial
  • Major Bleeding
Intervention  ICMJE
  • 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

Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Drug: Home Monitoring Guided OAC
  • Active Comparator: 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
    Intervention: Drug: Physician-Directed OAC
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.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 15, 2007)
2718
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE 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  ICMJE Not Provided
Responsible Party Biotronik, Inc.
Study Sponsor  ICMJE Biotronik, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
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