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Clinical trialNCT00559988TerminatedPhase 4Interventional

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

SponsorBiotronik, Inc.Enrollment2,718Atrial FibrillationAtrial FlutterEmbolism, Systemic ArterialMajor BleedingStroke
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

80 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia
  • Facility name not stated

    Wahroonga, Australia

Canada
  • Facility name not stated

    Montreal, Quebec, Canada

  • Facility name not stated

    Sherbrooke, Quebec, Canada

Denmark
  • Facility name not stated

    Aarhus, Denmark

Germany
  • Facility name not stated

    Tübingen, Germany

  • Facility name not stated

    Villingen, Germany

United Kingdom
  • Facility name not stated

    Birmingham, United Kingdom

United States
  • Facility name not stated

    Phoenix, Arizona, United States

  • Facility name not stated

    Scottsdale, Arizona, United States

  • Facility name not stated

    Anaheim, California, United States

  • Facility name not stated

    Fremont, California, United States

  • Facility name not stated

    Santa Barbara, California, United States

  • Facility name not stated

    Torrance, California, United States

  • Facility name not stated

    Ventura, California, United States

  • Facility name not stated

    Aurora, Colorado, United States

  • Facility name not stated

    Boulder, Colorado, United States

  • Facility name not stated

    Newark, Delaware, United States

  • Facility name not stated

    Davenport, Florida, United States

  • Facility name not stated

    Daytona Beach, Florida, United States

  • Facility name not stated

    Kissimmee, Florida, United States

  • Facility name not stated

    Melbourne, Florida, United States

  • Facility name not stated

    Sarasota, Florida, United States

  • Facility name not stated

    St. Petersburg, Florida, United States

  • Facility name not stated

    Zephyrhills, Florida, United States

  • Facility name not stated

    Chicago, Illinois, United States

  • Facility name not stated

    Elk Grove Village, Illinois, United States

  • Facility name not stated

    Maywood, Illinois, United States

  • Facility name not stated

    Fort Wayne, Indiana, United States

  • Facility name not stated

    Valparaiso, Indiana, United States

  • Facility name not stated

    Shawnee Mission, Kansas, United States

  • Facility name not stated

    Lexington, Kentucky, United States

  • Facility name not stated

    Louisville, Kentucky, United States

  • Facility name not stated

    Owensboro, Kentucky, United States

  • Facility name not stated

    Hammond, Louisiana, United States

  • Facility name not stated

    Lafayette, Louisiana, United States

  • Facility name not stated

    New Orleans, Louisiana, United States

  • Facility name not stated

    Bangor, Maine, United States

  • Facility name not stated

    Lewiston, Maine, United States

  • Facility name not stated

    Cumberland, Maryland, United States

  • Facility name not stated

    Boston, Massachusetts, United States

40 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Home Monitoring Guided OACPhysician-Directed OAC
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
29 Feb 2008
Primary completion
30 Jun 2013
Completion
30 Jun 2013
Last update posted
5 Dec 2017
Registered enrollment
2,718
Registry id
NCT00559988

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.