Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Biotronik, Inc.
ClinicalTrials.gov Identifier:
NCT00559988
First received: November 15, 2007
Last updated: June 23, 2014
Last verified: June 2014
History of Changes

November 15, 2007
June 23, 2014
February 2008
June 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
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 ]
Complete list of historical versions of study NCT00559988 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Secondary endpoints will be evaluated in a hierachical closed test procedure. If at the termination of the study, the result for the primary endpoint is found to have reached statistical significance, then Secondary Endpoints will be tested in turn for statistical significance at a 0.05 significance level. If at any stage, however, a non-significant result is found, no further testing of remaining secondary endpoints for statistical analysis will occur.
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 ]
Not Provided
Not Provided
 
Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk
The IMPACT of BIOTRONIK Home Monitoring Guided Anticoagulation on Stroke Risk in Patients With ICD and CRT-D Devices

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.

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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
  • Atrial Fibrillation
  • Atrial Flutter
  • Stroke
  • Embolism, Systemic Arterial
  • Major Bleeding
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2718
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Denmark,   Germany,   United Kingdom
 
NCT00559988
IMPACT
Yes
Biotronik, Inc.
Biotronik, Inc.
Not Provided
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
Biotronik, Inc.
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP