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

• Status: Terminated
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biotronik, Inc.
• Treatments: Dabigatran

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