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This study has been completed.
Information provided by (Responsible Party):
Boston Scientific Corporation Identifier:
First received: February 22, 2010
Last updated: July 5, 2017
Last verified: July 2017
Long term follow-up to monitor safety for patients implanted with a B301 ASSURE device.

Condition Intervention
Sudden Cardiac Death Bradycardia Device: AV Therapy Assessment-B301 investigational device

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Research Evaluation of the ASSURE Device Atrial and Ventricular Tachyarrhythmia Therapies Registry

Resource links provided by NLM:

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Enrollment: 211
Study Start Date: April 2006
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AV Therapy Assessment group
appropriate system performance of the atrial and ventricular tachyarrhythmia therapies in the ASSURE device
Device: AV Therapy Assessment-B301 investigational device
Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational 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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01074034

  Show 36 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
  More Information

Responsible Party: Boston Scientific Corporation Identifier: NCT01074034     History of Changes
Other Study ID Numbers: G040067
Study First Received: February 22, 2010
Results First Received: March 17, 2017
Last Updated: July 5, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Death, Sudden, Cardiac
Pathologic Processes
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Death, Sudden
Arrhythmias, Cardiac processed this record on September 21, 2017