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CompletedNCT00873691Tilt & TuneUpdated Feb 4, 2019

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

An observational study in Healthy, sponsored by Abbott Medical Devices. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-04.

Sponsored by Abbott Medical Devices · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
129
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy

Keywords

  • Patients indicated for an ICD/ CRT-D
03

In context

Lead sponsor

Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients with approved ICD/CRT-D indications

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

Exclusion Criteria:

  • Patient is pregnant.
  • Patient is less than 18 years old.
  • SVC coil was turned ON during DFT testing
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
129 participants (actual)
Patient registry
No

Groups and cohorts

  • 1

    ICD shocks programmed to Tuned Waveform

    Device: ICD

  • 2

    ICD shocks programmed to 50% Tilt waveform

    Device: ICD

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.

06

What researchers measure

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

07

Study locations

1 site
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
08

References and documents

Publications

  • Varma N, Efimov I. Right pectoral implantable cardioverter defibrillators: role of the proximal (SVC) coil. Pacing Clin Electrophysiol. 2008 Aug;31(8):1025-35. doi: 10.1111/j.1540-8159.2008.01130.x. PubMed 18684259 ↗
  • Natarajan S, Henthorn R, Burroughs J, Esberg D, Zweibel S, Ross T, Kroll M, Gianola D, Oza A. "Tuned" defibrillation waveforms outperform 50/50% tilt defibrillation waveforms: a randomized multi-center study. Pacing Clin Electrophysiol. 2007 Jan;30 Suppl 1:S139-42. doi: 10.1111/j.1540-8159.2007.00624.x. Erratum In: Pacing Clin Electrophysiol. 2007 Nov;30(11):1424. PubMed 17302691 ↗
  • Varma N, Schaerf R, Kalbfleisch S, Pimentel R, Kroll MW, Oza A. Defibrillation thresholds with right pectoral implantable cardioverter defibrillators and impact of waveform tuning (the Tilt and Tune trial). Europace. 2017 Nov 1;19(11):1810-1817. doi: 10.1093/europace/euw306. PubMed 27986795 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00873691
Lead sponsor
Abbott Medical Devices
Responsible party
Sponsor
First posted
Apr 1, 2009
Start date
Mar 2009
Primary completion
Nov 2011
Completion
Nov 2011
Last update
Feb 4, 2019

Study contacts

Niraj Varma, MD
principal investigator · The Cleveland Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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