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Clinical Trials/NCT01325922
NCT01325922CompletedNot Applicable

50/50% Tilt and Tune Defibrillation Waveforms Utilizing High Voltage Lead Integrity Check Impedance

Abbott Medical Devices0 sitesStarted: January 1, 2005Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

50/50% Tilt

Other

Intervention: DFT Testing with a 50/50% tilt (Procedure)

Investigators

Sponsor Class
Industry

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