50/50% Tilt and Tuned Defibrillation Waveform

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01325922
Recruitment Status : Completed
First Posted : March 30, 2011
Last Update Posted : March 31, 2011
Information provided by:
St. Jude Medical

Brief Summary:

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.

Study Methods

  • 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)
Allocation: Randomized
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

Arm Intervention/treatment
50/50% Tilt Procedure: DFT Testing with a 50/50% tilt

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Patient is a candidate for ICD implantation.
  • Patient is able to tolerate DFT testing.

Exclusion Criteria:

  • Patient has a mechanical valve in the tricuspid position.
  • Patient is pregnant.
  • Patient is less than 18 years old.

Responsible Party: Director, Clinical Affairs, St. Jude Medical Identifier: NCT01325922     History of Changes
Other Study ID Numbers: CRD 274
First Posted: March 30, 2011    Key Record Dates
Last Update Posted: March 31, 2011
Last Verified: March 2011