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

Completed

• Conditions: Healthy
• Interventions: Device: ICD

• Registration Number: NCT00873691
• Lead Sponsor: Abbott Medical Devices

Brief 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.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-30
• Study First Submitted QC: 2009-03-31
• Study First Posted: 2009-04-01
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	ICD	ICD shocks programmed to Tuned Waveform
2	ICD	ICD shocks programmed to 50% Tilt waveform

Primary Outcome Measures

Name	Time	Method
True Design for Test (DFTs) in fixed tilt and tuned waveforms obtained in volts (V)	Baseline

Secondary Outcome Measures

Name	Time	Method
True DFTs in fixed tilt and tuned waveforms obtained in joules (J)	Baseline

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States