REASSURE AV Registry

Not Applicable

Completed

• Conditions: Bradycardia; Sudden Cardiac Death
• Interventions: Device: AV Therapy Assessment-B301 investigational device

• Registration Number: NCT01074034
• Lead Sponsor: Boston Scientific Corporation

Brief 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.

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2010-02-22
• Study First Submitted QC: 2010-02-22
• Study First Posted: 2010-02-24
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2017-03-17
• Results First Submitted QC: 2017-05-17
• Results First Posted: 2017-06-14
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-05
• Last Update Posted: 2017-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AV Therapy Assessment group	AV Therapy Assessment-B301 investigational device	appropriate system performance of the atrial and ventricular tachyarrhythmia therapies in the ASSURE device

Primary Outcome Measures

Name	Time	Method
Inappropriate Shock Free Rate	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

Name	Time	Method
Conversion Success Rate up to Three Months Post-implant	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.

Trial Locations

Locations (36)

Alaska Heart Institute; 🇺🇸 Anchorage, Alaska, United States

Northern California Heart Care; 🇺🇸 Larkspur, California, United States

Orlando Regional Hospital; 🇺🇸 Orlando, Florida, United States

Heart and Vascular Institute; 🇺🇸 Saint Petersburg, Florida, United States

Piedmont Hospital; 🇺🇸 Atlanta, Georgia, United States

St. Joseph Hospital; 🇺🇸 Savannah, Georgia, United States

Good Samaritan Hospital; 🇺🇸 Downers Grove, Illinois, United States

Heart Care Research Foundation; 🇺🇸 Merrionette Park, Illinois, United States

St. Mary Medical Center; 🇺🇸 Hobart, Indiana, United States

Mercy Hospital Medical Center; 🇺🇸 Des Moines, Iowa, United States

Scroll for more (26 remaining)