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

NCT00559988 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2718

Last updated 2017-12-05

Study results available
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Summary

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Biotronik, Inc.

    lead INDUSTRY

Principal Investigators

  • Jonathan L Halperin, M.D. · Mount Sinai Medical Center, New York, NY

  • John Ip, M.D. · Thoracic & Cardiovascular Healthcare Foundation, Lansing, MI

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • United States
  • Australia
  • Canada
  • Denmark
  • Germany
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00559988 on ClinicalTrials.gov