NCT00874445

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 a single coil active can configuration.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 2, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

Enrollment Period

1.5 years

First QC Date

March 31, 2009

Last Update Submit

February 1, 2019

Conditions

Sudden Cardiac Death

Outcome Measures

Primary Outcomes (1)

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

    Implant

Secondary Outcomes (1)

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

    Implant

Study Arms (2)

ICD shocks programmed to Tuned Waveform

ICD shocks programmed to Tuned Waveform

Device: ICD/ CRT-D

ICD shocks programmed to Fixed Tilt Waveform

ICD shocks programmed to Fixed Tilt Waveform

Device: ICD/ CRT-D

Interventions

ICD/ CRT-DDEVICE

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.

ICD shocks programmed to Fixed Tilt WaveformICD shocks programmed to Tuned Waveform

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with ICD/CRT-D indications

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michael Gold

Charleston, South Carolina, 29425, United States

Location

Related Publications (5)

  • Gold M, Val-Mejias J, Leman RB, Tummala R, Goyal S, Kluger J, Kroll M, Oza A. Optimization of superior vena cava coil position and usage for transvenous defibrillation. Heart Rhythm. 2008 Mar;5(3):394-9. doi: 10.1016/j.hrthm.2007.12.001. Epub 2007 Dec 5.

    PMID: 18313597BACKGROUND

  • 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.

    PMID: 17302691BACKGROUND

  • Mouchawar G, Kroll M, Val-Mejias JE, Schwartzman D, McKenzie J, Fitzgerald D, Prater S, Katcher M, Fain E, Syed Z. ICD waveform optimization: a randomized, prospective, pair-sampled multicenter study. Pacing Clin Electrophysiol. 2000 Nov;23(11 Pt 2):1992-5. doi: 10.1111/j.1540-8159.2000.tb07070.x.

    PMID: 11139975BACKGROUND

  • Gold MR, Val-Mejias J, Cuoco F, Siddiqui M. Comparison of fixed tilt and tuned defibrillation waveforms: the PROMISE study. J Cardiovasc Electrophysiol. 2013 Mar;24(3):323-7. doi: 10.1111/jce.12041. Epub 2012 Dec 4.

    PMID: 23210764RESULT

  • Gold MR, Yu Y, Singh JP, Birgersdotter-Green U, Stein KM, Wold N, Meyer TE, Ellenbogen KA. Effect of Interventricular Electrical Delay on Atrioventricular Optimization for Cardiac Resynchronization Therapy. Circ Arrhythm Electrophysiol. 2018 Aug;11(8):e006055. doi: 10.1161/CIRCEP.117.006055.

    PMID: 30354310DERIVED

MeSH Terms

Conditions

Death, Sudden, Cardiac

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DefibrillatorsElectrodesElectrical Equipment and SuppliesEquipment and SuppliesElectrodes, ImplantedProstheses and Implants

Study Officials

  • Michael Gold, MD, PhD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2009

First Posted

April 2, 2009

Study Start

March 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

February 4, 2019

Record last verified: 2019-02

Locations

US(1)