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 12, 2013
Last verified: June 2013
  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:
  • 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 ] [ Designated as safety issue: No ]

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 ]

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

  Hide Study Locations
Locations
United States, Arizona
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
United States, California
Anaheim, California, United States
Fremont, California, United States
Santa Barbara, California, United States
Torrance, California, United States
Ventura, California, United States
United States, Colorado
Aurora, Colorado, United States
Boulder, Colorado, United States
United States, Delaware
Newark, Delaware, United States
United States, Florida
Davenport, Florida, United States
Daytona Beach, Florida, United States
Kissimmee, Florida, United States
Melbourne, Florida, United States
Sarasota, Florida, United States
St. Petersburg, Florida, United States
Zephyrhills, Florida, United States
United States, Illinois
Chicago, Illinois, United States
Elk Grove Village, Illinois, United States
Maywood, Illinois, United States
United States, Indiana
Fort Wayne, Indiana, United States
Valparaiso, Indiana, United States
United States, Kansas
Shawnee Mission, Kansas, United States
United States, Kentucky
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Owensboro, Kentucky, United States
United States, Louisiana
Hammond, Louisiana, United States
Lafayette, Louisiana, United States
New Orleans, Louisiana, United States
United States, Maine
Bangor, Maine, United States
Lewiston, Maine, United States
United States, Maryland
Cumberland, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
Burlington, Massachusetts, United States
Worcester, Massachusetts, United States
United States, Michigan
Ann Arbor, Michigan, United States
Bay City, Michigan, United States
Lansing, Michigan, United States
Lapeer, Michigan, United States
Saginaw, Michigan, United States
Ypsilanti, Michigan, United States
United States, Minnesota
Minneapolis, Minnesota, United States
United States, Mississippi
Tupelo, Mississippi, United States
United States, Missouri
Kansas City, Missouri, United States
Osage Beach, Missouri, United States
St. Louis, Missouri, United States
United States, Nebraska
Omaha, Nebraska, United States
United States, New Jersey
Ridgewood, New Jersey, United States
United States, New York
New York, New York, United States
United States, North Carolina
Durham, North Carolina, United States
Hickory, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Kettering, Ohio, United States
Middletown, Ohio, United States
Toledo, Ohio, United States
Westlake, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
United States, Oregon
Tualatin, Oregon, United States
United States, Pennsylvania
Abington, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Phoenixville, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Greenville, South Carolina, United States
Rock Hill, South Carolina, United States
United States, Tennessee
Cookeville, Tennessee, United States
Germantown, Tennessee, United States
Nashville, Tennessee, United States
United States, Texas
Corpus Christi, Texas, United States
Houston, Texas, United States
Humble, Texas, United States
Kingwood, Texas, United States
Australia
Wahroonga, Australia
Canada, Quebec
Montreal, Quebec, Canada
Sherbrooke, Quebec, Canada
Denmark
Aarhus, Denmark
Germany
Tubingen, Germany
Villingen, Germany
United Kingdom
Birmingham, United Kingdom
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
Last Updated: June 12, 2013
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 April 15, 2014