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

Phase 4 Terminated 2718 enrolled Biotronik, Inc.

RandomizedParallel-groupSingle-blindPrevention

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.

Timeline

Start: 2008-02
Primary completion: 2013-06
Completion: 2013-06

Publications

Martin DT, Bersohn MM, Waldo AL, Wathen MS, Choucair WK, Lip GY, Ip J, Holcomb R, Akar JG, Halperin JL; IMPACT Investigators. Randomized trial of atrial arrhythmia monitoring to guide anticoagulation in patients with implanted defibrillator and cardiac resynchronization devices. Eur Heart J. 2015 Jul 7;36(26):1660-8. doi: 10.1093/eurheartj/ehv115. Epub 2015 Apr 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Background	Dabigatran etexilate	Unknown	—	Oral
Background	Rivaroxaban	Other / unclassified	—	Oral
Background	Warfarin	Small molecule	—	Oral

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

Summary

Timeline

Publications

Drugs

Indications