REASSURE AV Registry

Boston Scientific

Status: Completed

Conditions: Bradycardia; Sudden Cardiac Death

Treatments: Device: AV Therapy Assessment-B301 investigational device

Study type: Interventional

Funder types: Industry

Identifiers

NCT01074034

G040067

Details and patient eligibility

About

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

Full 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.

Enrollment: 211 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

* None

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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211 participants in 1 patient group

AV Therapy Assessment group

Experimental group

Description:

appropriate system performance of the atrial and ventricular tachyarrhythmia therapies in the ASSURE device

Treatment:

Device: AV Therapy Assessment-B301 investigational device