50/50% Tilt and Tuned Defibrillation Waveform
|ClinicalTrials.gov Identifier: NCT01325922|
Recruitment Status : Completed
First Posted : March 30, 2011
Last Update Posted : March 31, 2011
Study Description The purpose of this study is to compare the defibrillation efficacy between the 50/50% tilt biphasic waveform and the Tuned biphasic waveform utilizing High Voltage Lead Integrity Check (HVLIC) impedance.
Hypothesis The Tuned waveform reduces defibrillation thresholds (DFTs) when compared to the 50/50% tilt waveform.
- This is an acute, paired-sample, randomized (waveform testing sequence) study
- Patients are implanted with an Food and Drug Administration (FDA) approved St. Jude Medical (SJM) EpicTM+ DR/VR Implantable Cardioverter Defibrillator (or any other standard output ICD after Epic+) and defibrillation lead system.
- All study testing is completed at implant.
- Patients are randomized to begin DFT testing with either the 50/50% tilt or Tuned waveform.
- The HVLIC feature is used to measure the high voltage lead impedance and to program the Tuned and 50/50% tilt waveform pulse widths.
- The DFT is determined by an optimized binary search method that is designed to reduce the overall number of VF inductions to an average of 5.13 while maintaining very high resolution and accuracy.
- Total # of centers - 15 centers
- Sample size - 60 patients
|Condition or disease||Intervention/treatment||Phase|
|DFT Testing||Procedure: DFT Testing with a 50/50% tilt||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|Official Title:||50/50% Tilt and Tune Defibrillation Waveforms Utilizing High Voltage Lead Integrity Check Impedance|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||November 2005|
|Actual Study Completion Date :||November 2005|
Procedure: DFT Testing with a 50/50% tilt