This study will assess whether an implantable defibrillator will increase the likelihood of survival in patients who have had a heart attack, have abnormal test results from a 24 hour heart monitor, and who have low normal heart function.
The REFINE ICD trial will assess whether prophylactic ICD therapy, guided by non-invasive risk assessment tools, reduces mortality in MI survivors with better-preserved LV function.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
700
Any Medtronic approved single chamber or dual chamber implantable cardioverter defibrillator (ICD)
Usual post-MI care
Mortality
Time frame: Minimum of 18 months of follow-up (average follow-up of 5 years).
Cardiac death
Time frame: Average follow-up 5 years.
Arrhythmic death
Time frame: Average follow-up 5 years.
Arrhythmic syncope
Time frame: Average follow-up 5 years.
Appropriate ICD therapies
Time frame: Average follow-up 5 years.
Quality of life
Time frame: Average follow-up 5 years.
Inappropriate ICD therapies
Time frame: Five years (average)
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Heart Center Research LLC
Huntsville, Alabama, United States
Colorado Heart and Vascular
Lakewood, Colorado, United States
James A Haley Veterans' Center
Tampa, Florida, United States
The Heart Group/Deaconess
Evansville, Indiana, United States
Iowa Heart Center
West Des Moines, Iowa, United States
Delmarva Heart Foundation
Salisbury, Maryland, United States
Beth Israel Deaconess
Boston, Massachusetts, United States
Washington University Medical School
Saint Louis, Michigan, United States
St. John Providence Hospital
Southfield, Michigan, United States
Lester E Cox Medical Center
Springfield, Missouri, United States
...and 69 more locations