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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00559988
Recruitment Status : Terminated
First Posted : November 19, 2007
Results First Posted : June 23, 2014
Last Update Posted : December 5, 2017
Information provided by (Responsible Party):
Biotronik, Inc.

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Atrial Flutter Stroke Embolism, Systemic Arterial Major Bleeding Drug: Home Monitoring Guided OAC Drug: Physician-Directed OAC Phase 4

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 : Interventional  (Clinical Trial)
Actual Enrollment : 2718 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: The IMPACT of BIOTRONIK Home Monitoring Guided Anticoagulation on Stroke Risk in Patients With ICD and CRT-D Devices
Study Start Date : February 2008
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
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

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:

  • 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
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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.

  8. Mean Ventricular Heart Rate Reduction [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00559988

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Sponsors and Collaborators
Biotronik, Inc.
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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Biotronik, Inc. Identifier: NCT00559988     History of Changes
Other Study ID Numbers: IMPACT
First Posted: November 19, 2007    Key Record Dates
Results First Posted: June 23, 2014
Last Update Posted: December 5, 2017
Last Verified: November 2017

Keywords provided by Biotronik, Inc.:
Implanted Cardioverter Defibrillator
Cardiac Resynchronization Therapy Defibrillator
Home Monitoring
Oral Anticoagulation

Additional relevant MeSH terms:
Atrial Fibrillation
Atrial Flutter
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Embolism and Thrombosis
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action