REASSURE AV Registry (REASSURE)

July 5, 2017 updated by: Boston Scientific Corporation

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

211

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alaska
      • Anchorage, Alaska, United States
        • Alaska Heart Institute
    • California
      • Larkspur, California, United States
        • Northern California Heart Care
    • Florida
      • Orlando, Florida, United States
        • Orlando Regional Hospital
      • Saint Petersburg, Florida, United States
        • Heart and Vascular Institute
    • Georgia
      • Atlanta, Georgia, United States
        • Piedmont Hospital
      • Savannah, Georgia, United States
        • St. Joseph Hospital
    • Illinois
      • Downers Grove, Illinois, United States
        • Good Samaritan Hospital
      • Merrionette Park, Illinois, United States
        • Heart Care Research Foundation
    • Indiana
      • Hobart, Indiana, United States
        • St. Mary Medical Center
    • Iowa
      • Des Moines, Iowa, United States
        • Mercy Hospital Medical Center
    • Kentucky
      • Lexington, Kentucky, United States
        • Central Baptist Hospital
      • Louisville, Kentucky, United States
        • Louisville Cardiology Medical Group
      • Louisville, Kentucky, United States
        • Medical Center Cardiologist Research
      • Owensboro, Kentucky, United States
        • Owensboro Mercy Health System
    • Louisiana
      • New Orleans, Louisiana, United States
        • Ochsner Foundation Hospital
    • Massachusetts
      • Boston, Massachusetts, United States
        • Boston Medical Center
      • Burlington, Massachusetts, United States
        • Lahey Clinic Medical Center
      • Springfield, Massachusetts, United States
        • Baystate Medical Center
      • Worcester, Massachusetts, United States
        • University of Massachusetts
    • Michigan
      • Detroit, Michigan, United States
        • Henry Ford Hospital
    • Minnesota
      • Duluth, Minnesota, United States
        • Saint Mary's Duluth Clinic
    • Missouri
      • Saint Louis, Missouri, United States
        • St. Anthony's Medical Center
    • Nevada
      • Las Vegas, Nevada, United States
        • Sunrise Hospital & Medical Center
    • New Jersey
      • Browns Mills, New Jersey, United States
        • Deborah Heart and Lung Center
    • New York
      • New York, New York, United States
        • Mount Sinai Medical Center
    • Ohio
      • Cincinnati, Ohio, United States
        • Christ Hospital - Cincinnati
      • Cleveland, Ohio, United States
        • The Cleveland Clinic Foundation
      • Columbus, Ohio, United States
        • Ohio State University Medical Center
    • Oklahoma
      • Tulsa, Oklahoma, United States
        • Hillcrest Medical Center
    • Pennsylvania
      • Abington, Pennsylvania, United States
        • Abington Memorial Hospital
      • West Reading, Pennsylvania, United States
        • Reading Hospital and Medical Center
    • Texas
      • Dallas, Texas, United States
        • Baylor University Medical Center
      • Houston, Texas, United States
        • Center for Cardiac Arrhythmias
    • Virginia
      • Fairfax, Virginia, United States
        • Inova Fairfax Hospital
      • Norfolk, Virginia, United States
        • Sentara Norfolk General Hospital
      • Richmond, Virginia, United States
        • Chippenham Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Three months post-implant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Three months post-implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

February 22, 2010

First Submitted That Met QC Criteria

February 22, 2010

First Posted (Estimate)

February 24, 2010

Study Record Updates

Last Update Posted (Actual)

August 1, 2017

Last Update Submitted That Met QC Criteria

July 5, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G040067

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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