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

November 1, 2017 updated by: Biotronik, Inc.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

2718

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Wahroonga, Australia
  • Canada
    • Quebec
      • Montreal, Quebec, Canada
      • Sherbrooke, Quebec, Canada
  • Denmark
      • Aarhus, Denmark
  • Germany
      • Tubingen, Germany
      • Villingen, Germany
  • United Kingdom
      • Birmingham, United Kingdom
  • United States
    • Arizona
      • Phoenix, Arizona, United States
      • Scottsdale, Arizona, United States
    • California
      • Anaheim, California, United States
      • Fremont, California, United States
      • Santa Barbara, California, United States
      • Torrance, California, United States
      • Ventura, California, United States
    • Colorado
      • Aurora, Colorado, United States
      • Boulder, Colorado, United States
    • Delaware
      • Newark, Delaware, United States
    • Florida
      • Davenport, Florida, United States
      • Daytona Beach, Florida, United States
      • Kissimmee, Florida, United States
      • Melbourne, Florida, United States
      • Saint Petersburg, Florida, United States
      • Sarasota, Florida, United States
      • Zephyrhills, Florida, United States
    • Illinois
      • Chicago, Illinois, United States
      • Elk Grove Village, Illinois, United States
      • Maywood, Illinois, United States
    • Indiana
      • Fort Wayne, Indiana, United States
      • Valparaiso, Indiana, United States
    • Kansas
      • Shawnee Mission, Kansas, United States
    • Kentucky
      • Lexington, Kentucky, United States
      • Louisville, Kentucky, United States
      • Owensboro, Kentucky, United States
    • Louisiana
      • Hammond, Louisiana, United States
      • Lafayette, Louisiana, United States
      • New Orleans, Louisiana, United States
    • Maine
      • Bangor, Maine, United States
      • Lewiston, Maine, United States
    • Maryland
      • Cumberland, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
      • Burlington, Massachusetts, United States
      • Worcester, Massachusetts, 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
    • Minnesota
      • Minneapolis, Minnesota, United States
    • Mississippi
      • Tupelo, Mississippi, United States
    • Missouri
      • Kansas City, Missouri, United States
      • Osage Beach, Missouri, United States
      • Saint Louis, Missouri, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • New Jersey
      • Ridgewood, New Jersey, United States
    • New York
      • New York, New York, United States
    • North Carolina
      • Durham, North Carolina, United States
      • Hickory, North Carolina, 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
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
      • Tulsa, Oklahoma, United States
    • Oregon
      • Tualatin, Oregon, United States
    • Pennsylvania
      • Abington, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Phoenixville, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • South Carolina
      • Greenville, South Carolina, United States
      • Rock Hill, South Carolina, United States
    • Tennessee
      • Cookeville, Tennessee, United States
      • Germantown, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Corpus Christi, Texas, United States
      • Houston, Texas, United States
      • Humble, Texas, United States
      • Kingwood, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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:

  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From date of enrollment until date of primary endpoint event, assessed up to study exit, with a mean treatment duration of 2.0 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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
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.
1 year
Mean Ventricular Heart Rate Reduction
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

November 15, 2007

First Submitted That Met QC Criteria

November 15, 2007

First Posted (Estimate)

November 19, 2007

Study Record Updates

Last Update Posted (Actual)

December 5, 2017

Last Update Submitted That Met QC Criteria

November 1, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMPACT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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