PREPARE Trial Design for Reducing ICD Therapy Morbidity
Author Information
Author(s): Wilkoff Bruce L, Stern Richard, Williamson Brian, Wathen Mark, Holloman Keith, Fieberg Ann, Brown Mark
Primary Institution: The Cleveland Clinic Lerner College of Medicine, Case Western Reserve University
Hypothesis
A pre-specified strategic profile of tachyarrhythmia detection and therapy parameters is able to reduce the overall morbidity of ICD therapy in patients with primary prevention ICD indications with or without cardiac resynchronization therapy.
Conclusion
The PREPARE study aims to evaluate programming strategies that may reduce the number of shocks delivered to patients with implantable cardioverter defibrillators.
Supporting Evidence
- The study includes 700 primary prevention patients.
- The control group consists of 691 historical patients from previous trials.
- The study aims to reduce inappropriate shocks and improve patient quality of life.
Takeaway
This study is trying to find a way to help patients with heart problems get fewer painful shocks from their heart devices.
Methodology
The study is a multi-center cohort study comparing a specific programming profile in 700 primary prevention patients to historical controls.
Potential Biases
There is a risk of underreporting adverse events in historical controls compared to the PREPARE study.
Limitations
The study may face bias due to differences in data collection methods between the PREPARE study and historical controls.
Participant Demographics
{"gender":{"male":79.3,"female":20.7},"mean_age":67.4,"ejection_fraction":27.7,"ischemic_cardiomyopathy":69.7}
Statistical Information
P-Value
0.05
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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