Skip to main content
OpenTrials
Completed

NCT Number: NCT01074034

REASSURE AV Registry

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sudden Cardiac Death Arrhythmias, Cardiac Bradycardia Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alaska Heart Institute, Anchorage, Alaska, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AV Therapy Assessment-B301 investigational device

Device

Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device

Primary outcomes

  1. Inappropriate Shock Free Rate

    Time frame: Three months post-implant

    Incidences of ventricular shock therapy up to three months post implant. Rescue shocks are intended for the treatment of cardiac arrhythmias detected in the ventricle at rates greater than 220 bpm, including arrhythmias that originate in the atria if they are conducted at rates greater than 220 bpm as this can be life threatening if persistent. Shocks delivered for other reasons will be considered inappropriate shocks.

Secondary outcomes

  1. Conversion Success Rate up to Three Months Post-implant

    Time frame: Three months post-implant

    For a pacemaker patient who experiences a spontaneous high rate ventricular arrhythmia, the ASSURE device may provide rescue shocks, a faster and more effective response than external methods of rescue. Successful conversion of an episode is defined by conversion to either; sinus rhythm, sinus tachycardia or atrial pacing by one minute post therapy delivery.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

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

Acronym: REASSURE

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Feb 24, 2010
Registry last updated
Aug 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.