The IMPACT study will investigate the clinical benefit of the combined use of BIOTRONIK Home Monitoring 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.

Eligibility Requirements

• At least 18 years of age
• Candidate for implantation of, or already implanted with, a BIOTRONIK Lumax HF-T or DR-T device
• Class one or two CRT-D or ICD implant indication
• Able and willing to follow anticoagulation therapy if the indication develops during the course of the trial
• Able to utilize the home monitoring (HM) system throughout the study
• Able to provide informed consent
• Geographically stable
• Able to return for expected regular follow-up visits for 36 months

For more information, contact Anthony Waldron Jr. at anthonywaldronjr@duke.edu or 919-681-9772.