NCT01074034

REASSURE AV Registry

Clinical Research Evaluation of the ASSURE Device Atrial and Ventricular Tachyarrhythmia Therapies Registry

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 211 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Long term follow-up to monitor safety for patients implanted with a B301 ASSURE device.

Detailed description

The Guidant ASSURE device is a fully featured pacemaker with additional atrial and ventricular tachyarrhythmia therapy features. The REASSURE AV study is a clinical evaluation to support approval of these features. This clinical study is intended to provide adequate performance data on two atrial tachyarrhythmia management features, namely the ATS and atrial ATP. In addition data will be collected to verify that the ventricular tachyarrhythmia rescue shock feature performs as intended in the clinical setting in combination with other pacemaker functions.

Conditions

• Sudden Cardiac Death
• Bradycardia

Interventions

Type	Name	Description
DEVICE	AV Therapy Assessment-B301 investigational device	Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device

Timeline

• Start date: 2006-04-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2010-02-24
• Last updated: 2017-08-01
• Results posted: 2017-06-14

Locations

36 sites across 1 country: United States