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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00873691

Acronym

Tilt & Tune

Enrollment

129

Registered

2009-04-01

Start date

2009-03-31

Completion date

2011-11-30

Last updated

2019-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Patients indicated for an ICD/ CRT-D

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.

Interventions

DEVICEICD

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
True DFTs in fixed tilt and tuned waveforms obtained in joules (J)	Baseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026