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Completed

NCT Number: NCT00873691

Comparison of Fixed Tilt and Tuned Waveforms in Right-sided Implants

The purpose of this study is to compare the defibrillation efficacy between the 50/50% tilt biphasic waveform and the Tuned biphasic waveform in patients with right-sided implants.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

Current era implantable cardioverter defibrillators (ICDs) have high defibrillation efficacy. This has stimulated a debate about whether DFT testing should be performed at all.1-3 However, this dialog has primarily centered around left sided implants, a group that is characterized by a small incidence of high defibrillation thresholds (DFTs).

The mechanism of phase duration programming to improve DFTs would seem to be most effectively applied to a group of patients with a high incidence of high DFTs such as right sided implants. This study therefore aims to prospectively evaluate direct phase duration programming on DFTs in right sided implants.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patient meets standard indication for an ICD/ CRT-D
  • Patient will be implanted with an FDA approved SJM ICD/ CRT-D that has a higher capacitance (maximum delivered energy - 36 J)
  • Pulse generator will be implanted on the right-side
  • Patient is able to tolerate DFT testing.
  • RV lead will be placed in the RV apex or inferior septum

Exclusion criteria

  • Patient is pregnant.
  • Patient is less than 18 years old.
  • SVC coil was turned ON during DFT testing

Treatment and study plan

ICD

Device

Intervention isn an ICD. Patients in experimental group will have their ICDs programmed to Tuned waveform and those in the control group will have their ICDs programmed to Fixed Tilt waveform.

Primary outcomes

  1. True Design for Test (DFTs) in fixed tilt and tuned waveforms obtained in volts (V)

    Time frame: Baseline

Secondary outcomes

  1. True DFTs in fixed tilt and tuned waveforms obtained in joules (J)

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Prospective Comparison of 50/50% Tilt and Tuned Defibrillation Waveforms in Right-Sided Implants

Acronym: Tilt & Tune

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 1, 2009
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.

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