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CompletedNCT01325922Updated Feb 4, 2019

50/50% Tilt and Tuned Defibrillation Waveform

An interventional study of DFT Testing with a 50/50% tilt in DFT Testing, sponsored by Abbott Medical Devices. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-04.

Sponsored by Abbott Medical Devices · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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
02

Conditions studied

  • DFT Testing
03

In context

Lead sponsor

Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patient has a mechanical valve in the tricuspid position.
  • Patient is pregnant.
  • Patient is less than 18 years old.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment

Study arms

  • Other
    50/50% Tilt

    Procedure: DFT Testing with a 50/50% tilt

Interventions

  • ProcedureDFT Testing with a 50/50% tilt
06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01325922
Lead sponsor
Abbott Medical Devices
First posted
Mar 30, 2011
Start date
Jan 2005
Primary completion
Nov 2005
Completion
Nov 2005
Last update
Feb 4, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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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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