Comparison of Fixed Tilt and Tuned Waveforms in Right-sided Implants



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:2/6/2019
Start Date:March 2009
End Date:November 2011

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Prospective Comparison of 50/50% Tilt and Tuned Defibrillation Waveforms in Right-Sided Implants

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.

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 has primarily centered around left sided implants, a group that is
characterized by a small incidence of high defibrillation thresholds (DFTs).

The mechanism of phase duration programming to improve DFTs would seem to be most effectively
applied to a group of patients with a high incidence of high DFTs such as right sided
implants. This study therefore aims to prospectively evaluate direct phase duration
programming on DFTs in right sided implants.

Inclusion Criteria:

- 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 Criteria:

- Patient is pregnant.

- Patient is less than 18 years old.

- SVC coil was turned ON during DFT testing
We found this trial at
1
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
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