MedPath

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.

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
GroupInterventionDescription
AV Therapy Assessment groupAV Therapy Assessment-B301 investigational deviceappropriate system performance of the atrial and ventricular tachyarrhythmia therapies in the ASSURE device
Primary Outcome Measures
NameTimeMethod
Inappropriate Shock Free RateThree 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
NameTimeMethod
Conversion Success Rate up to Three Months Post-implantThree 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)

Owensboro Mercy Health System

🇺🇸

Owensboro, Kentucky, United States

Center For Cardiac Arrhythmias

🇺🇸

Houston, Texas, United States

Baylor University Medical Center

🇺🇸

Dallas, Texas, United States

Inova Fairfax Hospital

🇺🇸

Fairfax, Virginia, United States

Chippenham Medical Center

🇺🇸

Richmond, Virginia, United States

Sunrise Hospital & Medical Center

🇺🇸

Las Vegas, Nevada, United States

Christ Hospital - Cincinnati

🇺🇸

Cincinnati, Ohio, United States

Sentara Norfolk General Hospital

🇺🇸

Norfolk, Virginia, United States

Alaska Heart Institute

🇺🇸

Anchorage, Alaska, United States

Northern California Heart Care

🇺🇸

Larkspur, California, United States

Piedmont Hospital

🇺🇸

Atlanta, Georgia, United States

Heart and Vascular Institute

🇺🇸

Saint Petersburg, Florida, United States

St. Joseph Hospital

🇺🇸

Savannah, Georgia, United States

Good Samaritan Hospital

🇺🇸

Downers Grove, Illinois, United States

St. Mary Medical Center

🇺🇸

Hobart, Indiana, United States

Heart Care Research Foundation

🇺🇸

Merrionette Park, Illinois, United States

Mercy Hospital Medical Center

🇺🇸

Des Moines, Iowa, United States

Central Baptist Hospital

🇺🇸

Lexington, Kentucky, United States

Ochsner Foundation Hospital

🇺🇸

New Orleans, Louisiana, United States

Boston Medical Center

🇺🇸

Boston, Massachusetts, United States

Lahey Clinic Medical Center

🇺🇸

Burlington, Massachusetts, United States

Baystate Medical Center

🇺🇸

Springfield, Massachusetts, United States

University of Massachusetts

🇺🇸

Worcester, Massachusetts, United States

Saint Mary's Duluth Clinic

🇺🇸

Duluth, Minnesota, United States

St. Anthony's Medical Center

🇺🇸

Saint Louis, Missouri, United States

Deborah Heart and Lung Center

🇺🇸

Browns Mills, New Jersey, United States

Mount Sinai Medical Center

🇺🇸

New York, New York, United States

The Cleveland Clinic Foundation

🇺🇸

Cleveland, Ohio, United States

Ohio State University Medical Center

🇺🇸

Columbus, Ohio, United States

Hillcrest Medical Center

🇺🇸

Tulsa, Oklahoma, United States

Abington Memorial Hospital

🇺🇸

Abington, Pennsylvania, United States

Reading Hospital and Medical Center

🇺🇸

West Reading, Pennsylvania, United States

Orlando Regional Hospital

🇺🇸

Orlando, Florida, United States

Medical Center Cardiologist Research

🇺🇸

Louisville, Kentucky, United States

Louisville Cardiology Medical Group

🇺🇸

Louisville, Kentucky, United States

Henry Ford Hospital

🇺🇸

Detroit, Michigan, United States

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