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REASSURE AV Registry (REASSURE)

Primary Purpose

Sudden Cardiac Death, Bradycardia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AV Therapy Assessment-B301 investigational device
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sudden Cardiac Death

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alaska Heart Institute
  • Northern California Heart Care
  • Orlando Regional Hospital
  • Heart and Vascular Institute
  • Piedmont Hospital
  • St. Joseph Hospital
  • Good Samaritan Hospital
  • Heart Care Research Foundation
  • St. Mary Medical Center
  • Mercy Hospital Medical Center
  • Central Baptist Hospital
  • Louisville Cardiology Medical Group
  • Medical Center Cardiologist Research
  • Owensboro Mercy Health System
  • Ochsner Foundation Hospital
  • Boston Medical Center
  • Lahey Clinic Medical Center
  • Baystate Medical Center
  • University of Massachusetts
  • Henry Ford Hospital
  • Saint Mary's Duluth Clinic
  • St. Anthony's Medical Center
  • Sunrise Hospital & Medical Center
  • Deborah Heart and Lung Center
  • Mount Sinai Medical Center
  • Christ Hospital - Cincinnati
  • The Cleveland Clinic Foundation
  • Ohio State University Medical Center
  • Hillcrest Medical Center
  • Abington Memorial Hospital
  • Reading Hospital and Medical Center
  • Baylor University Medical Center
  • Center For Cardiac Arrhythmias
  • Inova Fairfax Hospital
  • Sentara Norfolk General Hospital
  • Chippenham Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AV Therapy Assessment group

Arm Description

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

Outcomes

Primary Outcome Measures

Inappropriate Shock Free Rate
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
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.

Full Information

First Posted
February 22, 2010
Last Updated
July 5, 2017
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01074034
Brief Title
REASSURE AV Registry
Acronym
REASSURE
Official Title
Clinical Research Evaluation of the ASSURE Device Atrial and Ventricular Tachyarrhythmia Therapies Registry
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sudden Cardiac Death, Bradycardia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
211 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AV Therapy Assessment group
Arm Type
Experimental
Arm Description
appropriate system performance of the atrial and ventricular tachyarrhythmia therapies in the ASSURE device
Intervention Type
Device
Intervention Name(s)
AV Therapy Assessment-B301 investigational device
Intervention Description
Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device
Primary Outcome Measure Information:
Title
Inappropriate Shock Free Rate
Description
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.
Time Frame
Three months post-implant
Secondary Outcome Measure Information:
Title
Conversion Success Rate up to Three Months Post-implant
Description
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.
Time Frame
Three months post-implant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Alaska Heart Institute
City
Anchorage
State/Province
Alaska
Country
United States
Facility Name
Northern California Heart Care
City
Larkspur
State/Province
California
Country
United States
Facility Name
Orlando Regional Hospital
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Heart and Vascular Institute
City
Saint Petersburg
State/Province
Florida
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
St. Joseph Hospital
City
Savannah
State/Province
Georgia
Country
United States
Facility Name
Good Samaritan Hospital
City
Downers Grove
State/Province
Illinois
Country
United States
Facility Name
Heart Care Research Foundation
City
Merrionette Park
State/Province
Illinois
Country
United States
Facility Name
St. Mary Medical Center
City
Hobart
State/Province
Indiana
Country
United States
Facility Name
Mercy Hospital Medical Center
City
Des Moines
State/Province
Iowa
Country
United States
Facility Name
Central Baptist Hospital
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
Louisville Cardiology Medical Group
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Medical Center Cardiologist Research
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Owensboro Mercy Health System
City
Owensboro
State/Province
Kentucky
Country
United States
Facility Name
Ochsner Foundation Hospital
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Lahey Clinic Medical Center
City
Burlington
State/Province
Massachusetts
Country
United States
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
Country
United States
Facility Name
University of Massachusetts
City
Worcester
State/Province
Massachusetts
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Saint Mary's Duluth Clinic
City
Duluth
State/Province
Minnesota
Country
United States
Facility Name
St. Anthony's Medical Center
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Sunrise Hospital & Medical Center
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Deborah Heart and Lung Center
City
Browns Mills
State/Province
New Jersey
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
Country
United States
Facility Name
Christ Hospital - Cincinnati
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Hillcrest Medical Center
City
Tulsa
State/Province
Oklahoma
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
Country
United States
Facility Name
Reading Hospital and Medical Center
City
West Reading
State/Province
Pennsylvania
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Center For Cardiac Arrhythmias
City
Houston
State/Province
Texas
Country
United States
Facility Name
Inova Fairfax Hospital
City
Fairfax
State/Province
Virginia
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
Chippenham Medical Center
City
Richmond
State/Province
Virginia
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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