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50/50% Tilt and Tuned Defibrillation Waveform

NCT01325922 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-02-04

No results posted yet for this 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

Conditions

  • DFT Testing

Interventions

PROCEDURE

DFT Testing with a 50/50% tilt

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2005-11-30
Completion
2005-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01325922 on ClinicalTrials.gov