50/50% Tilt and Tuned Defibrillation Waveform

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

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 Overview

• Status: Completed
• Conditions: DFT Testing
• Intervention / Treatment: Procedure: DFT Testing with a 50/50% tilt

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 50/50% Tilt	Procedure: DFT Testing with a 50/50% tilt

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (ACTUAL): November 1, 2005
• Study Completion (ACTUAL): November 1, 2005

Study Registration Dates

• First Submitted: May 16, 2007
• First Submitted That Met QC Criteria: March 28, 2011
• First Posted (ESTIMATE): March 30, 2011

Study Record Updates

• Last Update Posted (ACTUAL): February 4, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CRD 274