NCT00873691

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 129 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	ICD	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.

Timeline

• Start date: 2009-03-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2009-04-01
• Last updated: 2019-02-04

Locations

1 site across 1 country: United States