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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Device: ICD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>ICD shocks programmed to Tuned Waveform | Device: ICD<br>* Intervention isn an ICD. Patients in experimental group will have their ICDs programmed to Tuned waveform and those in the control group will have their ICDs programmed to Fixed Tilt waveform.<br>|
| 2<br>ICD shocks programmed to 50% Tilt waveform | Device: ICD<br>* Intervention isn an ICD. Patients in experimental group will have their ICDs programmed to Tuned waveform and those in the control group will have their ICDs programmed to Fixed Tilt waveform.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| True Design for Test (DFTs) in fixed tilt and tuned waveforms obtained in volts (V) |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| True DFTs in fixed tilt and tuned waveforms obtained in joules (J) |  | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patients indicated for an ICD/ CRT-D