Status:
COMPLETED
Comparison of 50% Tilt and Tuned Waveforms in Single-Coil Active Can Configuration
Lead Sponsor:
Abbott Medical Devices
Conditions:
Sudden Cardiac Death
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to compare the defibrillation efficacy between the 50/50% tilt biphasic waveform and the Tuned biphasic waveform in a single coil active can configuration.
Detailed Description
There has been one prospective study that found some benefit of using tuned waveforms over 50/50% tilt waveforms.11 Other studies have failed to show much change in defibrillation efficacy with differ...
Eligibility Criteria
Inclusion
- Patient meets standard indication for an ICD/ CRT-D and will be implanted with an FDA approved SJM ICD/ CRT-D and compatible defibrillation lead system in the left pectoral region.
- Patient is able to tolerate DFT testing.
Exclusion
- Patient has the pulse generator on the right side.
- Patient is pregnant.
- Patient is less than 18 years old.
- SVC coil was turned ON during DFT testing
Key Trial Info
Start Date :
March 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00874445
Start Date
March 1 2009
End Date
September 1 2010
Last Update
February 4 2019
Active Locations (1)
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1
Michael Gold
Charleston, South Carolina, United States, 29425