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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 a single coil active can configuration.
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 different duration biphasic waveforms. A vast majority of patients in these studies were tested with dual coil leads. Although dual coil leads can lower defibrillation thresholds, it is known that dual coil leads can make the lead extraction difficult, lead to venous obstruction and are more prone to failure. Results from a recent study showed that that a single coil configuration is adequate in a vast majority of patients when DFT testing was performed with tuned waveforms. This makes the use of single-coil leads during ICD/ CRT-D implants an attractive option.
Theoretical analysis has shown that difference between the tuned and 50% tilt waveforms is amplified at high impedance levels with tuned waveforms being superior (unpublished). Accordingly, this study has been designed to prospectively compare the DFT estimates with tuned and 50% tilt waveforms in left-sided, active pectoral defibrillation lead systems when the SVC coil has been turned OFF or is not part of the shocking circuit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICD shocks programmed to Tuned Waveform | ICD shocks programmed to Tuned Waveform |
| |
| ICD shocks programmed to Fixed Tilt Waveform | ICD shocks programmed to Fixed Tilt Waveform |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICD/ CRT-D | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| True DFTs in fixed tilt and tuned waveforms obtained in volts (V) | Implant |
| Measure | Description | Time Frame |
|---|---|---|
| True DFTs in fixed tilt and tuned waveforms obtained in joules (J) | Implant |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with ICD/CRT-D indications
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| Name | Affiliation | Role |
|---|---|---|
| Michael Gold, MD, PhD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michael Gold | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18313597 | Background | Gold M, Val-Mejias J, Leman RB, Tummala R, Goyal S, Kluger J, Kroll M, Oza A. Optimization of superior vena cava coil position and usage for transvenous defibrillation. Heart Rhythm. 2008 Mar;5(3):394-9. doi: 10.1016/j.hrthm.2007.12.001. Epub 2007 Dec 5. | |
| 17302691 | Background | Natarajan S, Henthorn R, Burroughs J, Esberg D, Zweibel S, Ross T, Kroll M, Gianola D, Oza A. "Tuned" defibrillation waveforms outperform 50/50% tilt defibrillation waveforms: a randomized multi-center study. Pacing Clin Electrophysiol. 2007 Jan;30 Suppl 1:S139-42. doi: 10.1111/j.1540-8159.2007.00624.x. |
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| ID | Term |
|---|---|
| D016757 | Death, Sudden, Cardiac |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003645 | Death, Sudden |
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| ID | Term |
|---|---|
| D017147 | Defibrillators, Implantable |
| ID | Term |
|---|---|
| D047548 | Defibrillators |
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
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| 11139975 | Background | Mouchawar G, Kroll M, Val-Mejias JE, Schwartzman D, McKenzie J, Fitzgerald D, Prater S, Katcher M, Fain E, Syed Z. ICD waveform optimization: a randomized, prospective, pair-sampled multicenter study. Pacing Clin Electrophysiol. 2000 Nov;23(11 Pt 2):1992-5. doi: 10.1111/j.1540-8159.2000.tb07070.x. |
| 23210764 | Result | Gold MR, Val-Mejias J, Cuoco F, Siddiqui M. Comparison of fixed tilt and tuned defibrillation waveforms: the PROMISE study. J Cardiovasc Electrophysiol. 2013 Mar;24(3):323-7. doi: 10.1111/jce.12041. Epub 2012 Dec 4. |
| 30354310 | Derived | Gold MR, Yu Y, Singh JP, Birgersdotter-Green U, Stein KM, Wold N, Meyer TE, Ellenbogen KA. Effect of Interventricular Electrical Delay on Atrioventricular Optimization for Cardiac Resynchronization Therapy. Circ Arrhythm Electrophysiol. 2018 Aug;11(8):e006055. doi: 10.1161/CIRCEP.117.006055. |
| D003643 |
| Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004567 |
| Electrodes, Implanted |
| D019736 | Prostheses and Implants |