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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Biotronik, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 2718
Study Start Date: February 2008
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:

  • 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
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


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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00559988

  Show 80 Study Locations
Sponsors and Collaborators
Biotronik, Inc.
Investigators
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
  More Information

No publications provided

Responsible Party: Biotronik, Inc.
ClinicalTrials.gov Identifier: NCT00559988     History of Changes
Other Study ID Numbers: IMPACT
Study First Received: November 15, 2007
Results First Received: May 20, 2014
Last Updated: June 23, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Atrial Fibrillation
Atrial Flutter
Embolism
Hemorrhage
Stroke
Cerebral Infarction
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 18, 2014