50/50% Tilt and Tuned Defibrillation Waveform

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

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Key information

Conditions

DFT Testing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DFT Testing with a 50/50% tilt

Procedure

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

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

Important dates

Study start: 2005
Primary completion: 2005
Study completion: 2005
First posted: Mar 30, 2011
Registry last updated: Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.