An observational study in Sudden Cardiac Death, sponsored by Abbott Medical Devices. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-04.
Sponsored by Abbott Medical Devices (part of Abbott) · Observational
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between the tuned and 50% tilt waveforms is amplified at high impedance levels with tuned waveforms being superior (unpublished).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.
322 studies on the registry are indexed under Death, Sudden, Cardiac; 81 are open to participants now.
This study's enrollment of 77 is below the median of 500 across 177 observational studies indexed under Death, Sudden, Cardiac.
Browse Death, Sudden, Cardiac studies →Abbott Medical Devices is the lead sponsor of 539 studies on the registry; 33 are open to participants now.
Of its 53 completed or terminated interventional studies of FDA-regulated products, 44 (83%) have results posted.
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Patients with ICD/CRT-D indications
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
ICD shocks programmed to Tuned Waveform
Device: ICD/ CRT-D
ICD shocks programmed to Fixed Tilt Waveform
Device: ICD/ CRT-D
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.
True DFTs in fixed tilt and tuned waveforms obtained in volts (V)
Time frame: Implant
True DFTs in fixed tilt and tuned waveforms obtained in joules (J)
Time frame: Implant
The record gives a start of Mar 2009, a primary completion of Sep 2010 and a completion of Sep 2010. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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