REASSURE AV Registry

NCT ID: NCT01074034

Last Updated: 2017-08-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

211 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2011-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Sudden Cardiac Death Bradycardia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AV Therapy Assessment group

appropriate system performance of the atrial and ventricular tachyarrhythmia therapies in the ASSURE device

Group Type EXPERIMENTAL

AV Therapy Assessment-B301 investigational device

Intervention Type DEVICE

Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device

Interventions

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AV Therapy Assessment-B301 investigational device

Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Alaska Heart Institute

Anchorage, Alaska, United States

Site Status

Northern California Heart Care

Larkspur, California, United States

Site Status

Orlando Regional Hospital

Orlando, Florida, United States

Site Status

Heart and Vascular Institute

St. Petersburg, Florida, United States

Site Status

Piedmont Hospital

Atlanta, Georgia, United States

Site Status

St. Joseph Hospital

Savannah, Georgia, United States

Site Status

Good Samaritan Hospital

Downers Grove, Illinois, United States

Site Status

Heart Care Research Foundation

Merrionette Park, Illinois, United States

Site Status

St. Mary Medical Center

Hobart, Indiana, United States

Site Status

Mercy Hospital Medical Center

Des Moines, Iowa, United States

Site Status

Central Baptist Hospital

Lexington, Kentucky, United States

Site Status

Louisville Cardiology Medical Group

Louisville, Kentucky, United States

Site Status

Medical Center Cardiologist Research

Louisville, Kentucky, United States

Site Status

Owensboro Mercy Health System

Owensboro, Kentucky, United States

Site Status

Ochsner Foundation Hospital

New Orleans, Louisiana, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

Lahey Clinic Medical Center

Burlington, Massachusetts, United States

Site Status

Baystate Medical Center

Springfield, Massachusetts, United States

Site Status

University of Massachusetts

Worcester, Massachusetts, United States

Site Status

Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Saint Mary's Duluth Clinic

Duluth, Minnesota, United States

Site Status

St. Anthony's Medical Center

St Louis, Missouri, United States

Site Status

Sunrise Hospital & Medical Center

Las Vegas, Nevada, United States

Site Status

Deborah Heart and Lung Center

Browns Mills, New Jersey, United States

Site Status

Mount Sinai Medical Center

New York, New York, United States

Site Status

Christ Hospital - Cincinnati

Cincinnati, Ohio, United States

Site Status

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Ohio State University Medical Center

Columbus, Ohio, United States

Site Status

Hillcrest Medical Center

Tulsa, Oklahoma, United States

Site Status

Abington Memorial Hospital

Abington, Pennsylvania, United States

Site Status

Reading Hospital and Medical Center

West Reading, Pennsylvania, United States

Site Status

Baylor University Medical Center

Dallas, Texas, United States

Site Status

Center For Cardiac Arrhythmias

Houston, Texas, United States

Site Status

Inova Fairfax Hospital

Fairfax, Virginia, United States

Site Status

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Site Status

Chippenham Medical Center

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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G040067

Identifier Type: -

Identifier Source: org_study_id

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