Status:
COMPLETED
Comparison of Fixed Tilt and Tuned Waveforms in Right-sided Implants
Lead Sponsor:
Abbott Medical Devices
Conditions:
Healthy
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 patients with right-sided implants.
Detailed Description
Current era implantable cardioverter defibrillators (ICDs) have high defibrillation efficacy. This has stimulated a debate about whether DFT testing should be performed at all.1-3 However, this dialog...
Eligibility Criteria
Inclusion
- Patient meets standard indication for an ICD/ CRT-D
- Patient will be implanted with an FDA approved SJM ICD/ CRT-D that has a higher capacitance (maximum delivered energy - 36 J)
- Pulse generator will be implanted on the right-side
- Patient is able to tolerate DFT testing.
- RV lead will be placed in the RV apex or inferior septum
Exclusion
- 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 :
November 1 2011
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT00873691
Start Date
March 1 2009
End Date
November 1 2011
Last Update
February 4 2019
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195