Clinical trial NCT01074034: REASSURE AV Registry
Official title: Clinical Research Evaluation of the ASSURE Device Atrial and Ventricular Tachyarrhythmia Therapies Registry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sudden Cardiac Death
Bradycardia
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2010-02-24
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Inappropriate Shock Free Rate
timeFrame: Three months post-implant
Secondary outcomes:
measure: Conversion Success Rate up to Three Months Post-implant
timeFrame: Three months post-implant
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Heart Institute
state: Alaska
city: Larkspur
country: United States
facility: Northern California Heart Care
state: California
city: Orlando
country: United States
facility: Orlando Regional Hospital
state: Florida
city: Saint Petersburg
country: United States
facility: Heart and Vascular Institute
state: Florida
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Savannah
country: United States
facility: St. Joseph Hospital
state: Georgia
city: Downers Grove
country: United States
facility: Good Samaritan Hospital
state: Illinois
city: Merrionette Park
country: United States
facility: Heart Care Research Foundation
state: Illinois
city: Hobart
country: United States
facility: St. Mary Medical Center
state: Indiana
city: Des Moines
country: United States
facility: Mercy Hospital Medical Center
state: Iowa
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Louisville
country: United States
facility: Louisville Cardiology Medical Group
state: Kentucky
city: Louisville
country: United States
facility: Medical Center Cardiologist Research
state: Kentucky
city: Owensboro
country: United States
facility: Owensboro Mercy Health System
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Foundation Hospital
state: Louisiana
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Duluth
country: United States
facility: Saint Mary's Duluth Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: St. Anthony's Medical Center
state: Missouri
city: Las Vegas
country: United States
facility: Sunrise Hospital & Medical Center
state: Nevada
city: Browns Mills
country: United States
facility: Deborah Heart and Lung Center
state: New Jersey
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Cincinnati
country: United States
facility: Christ Hospital - Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Tulsa
country: United States
facility: Hillcrest Medical Center
state: Oklahoma
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: West Reading
country: United States
facility: Reading Hospital and Medical Center
state: Pennsylvania
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Houston
country: United States
facility: Center For Cardiac Arrhythmias
state: Texas
city: Fairfax
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Richmond
country: United States
facility: Chippenham Medical Center
state: Virginia
Study officials:
References: