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Completed

NCT Number: NCT00874445

Comparison of 50% Tilt and Tuned Waveforms in Single-Coil Active Can Configuration

The purpose of this study is to compare the defibrillation efficacy between the 50/50% tilt biphasic waveform and the Tuned biphasic waveform in a single coil active can configuration.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Michael Gold

Charleston, South Carolina, 29425, United States

About this study

There has been one prospective study that found some benefit of using tuned waveforms over 50/50% tilt waveforms.11 Other studies have failed to show much change in defibrillation efficacy with different duration biphasic waveforms. A vast majority of patients in these studies were tested with dual coil leads. Although dual coil leads can lower defibrillation thresholds, it is known that dual coil leads can make the lead extraction difficult, lead to venous obstruction and are more prone to failure. Results from a recent study showed that that a single coil configuration is adequate in a vast majority of patients when DFT testing was performed with tuned waveforms. This makes the use of single-coil leads during ICD/ CRT-D implants an attractive option.

Theoretical analysis has shown that difference between the tuned and 50% tilt waveforms is amplified at high impedance levels with tuned waveforms being superior (unpublished). Accordingly, this study has been designed to prospectively compare the DFT estimates with tuned and 50% tilt waveforms in left-sided, active pectoral defibrillation lead systems when the SVC coil has been turned OFF or is not part of the shocking circuit.

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 and will be implanted with an FDA approved SJM ICD/ CRT-D and compatible defibrillation lead system in the left pectoral region.
  • Patient is able to tolerate DFT testing.

Exclusion criteria

  • Patient has the pulse generator on the right side.
  • Patient is pregnant.
  • Patient is less than 18 years old.
  • SVC coil was turned ON during DFT testing

Treatment and study plan

ICD/ CRT-D

Device

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 DFTs in fixed tilt and tuned waveforms obtained in volts (V)

    Time frame: Implant

Secondary outcomes

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

    Time frame: Implant

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 a Single Coil Active Can Configuration

Acronym: PROMISE

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 2, 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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