Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boston Scientific Corporation
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
The patient is willing and capable of providing informed consent at an approved clinical investigational center, and able to attend the investigational center as required by the protocol
Patient is implanted with an investigational B301 device as part of the REASSURE AV study
