REASSURE AV Registry
REASSURE
Clinical Research Evaluation of the ASSURE Device Atrial and Ventricular Tachyarrhythmia Therapies Registry
1 other identifier
interventional
211
1 country
36
Brief Summary
Long term follow-up to monitor safety for patients implanted with a B301 ASSURE device.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2006
Longer than P75 for not_applicable
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 22, 2010
CompletedFirst Posted
Study publicly available on registry
February 24, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedResults Posted
Study results publicly available
June 14, 2017
CompletedAugust 1, 2017
July 1, 2017
5.2 years
February 22, 2010
March 17, 2017
July 5, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Three months post-implant
Secondary Outcomes (1)
Conversion Success Rate up to Three Months Post-implant
Three months post-implant
Study Arms (1)
AV Therapy Assessment group
EXPERIMENTALappropriate system performance of the atrial and ventricular tachyarrhythmia therapies in the ASSURE device
Interventions
Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \* None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Alaska Heart Institute
Anchorage, Alaska, United States
Northern California Heart Care
Larkspur, California, United States
Orlando Regional Hospital
Orlando, Florida, United States
Heart and Vascular Institute
St. Petersburg, Florida, United States
Piedmont Hospital
Atlanta, Georgia, United States
St. Joseph Hospital
Savannah, Georgia, United States
Good Samaritan Hospital
Downers Grove, Illinois, United States
Heart Care Research Foundation
Merrionette Park, Illinois, United States
St. Mary Medical Center
Hobart, Indiana, United States
Mercy Hospital Medical Center
Des Moines, Iowa, United States
Central Baptist Hospital
Lexington, Kentucky, United States
Louisville Cardiology Medical Group
Louisville, Kentucky, United States
Medical Center Cardiologist Research
Louisville, Kentucky, United States
Owensboro Mercy Health System
Owensboro, 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
Henry Ford Hospital
Detroit, Michigan, United States
Saint Mary's Duluth Clinic
Duluth, Minnesota, United States
St. Anthony's Medical Center
St Louis, Missouri, United States
Sunrise Hospital & Medical Center
Las Vegas, Nevada, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States
Mount Sinai Medical Center
New York, New York, United States
Christ Hospital - Cincinnati
Cincinnati, Ohio, 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
Baylor University Medical Center
Dallas, Texas, United States
Center For Cardiac Arrhythmias
Houston, Texas, United States
Inova Fairfax Hospital
Fairfax, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Chippenham Medical Center
Richmond, Virginia, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Elke Sommerijns
- Organization
- Boston Scientific
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2010
First Posted
February 24, 2010
Study Start
April 1, 2006
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
August 1, 2017
Results First Posted
June 14, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share