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OpenTrials
Completed

NCT Number: NCT02027883

Comparison of VF Induction Techniques During Medtronic ICD Implant (VF) (ICD)

As the indications for Implantable Cardioverter Defibrillator implantation expand, minimizing implant time is critical. Also, patients receiving biventricular ICDs are sometimes more unstable and minimization of sedation time is crucial. Multiple induction attempts, with a 1-Joule shock, can cause disruption in lead position. Therefore limiting the number of attempts will allow for better lead stability throughout the procedure and a more straightforward implant process.

Investigator proposes a detailed documentation of success rates from various Ventriculart Fibrillation induction methods during implant of Medtronic defibrillation capable devices.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wellmont CVA Heart Institute

Kingsport, Tennessee, 37660, United States

About this study

Our clinical experience has found that attempts to induce patients receiving ICDs at implant using the nominal Medtronic T-shock settings are not always effective at inducing ventricular fibrillation. When this results, a change to the parameters for T-shock is made before reattempting to induce ventricular fibrillation in patients undergoing ICD implantation.

Another available induction method is 50 Hz Burst. "The 50 Hz Burst induction is designed to induce VF by delivering a rapid burst of pacing pulses. The amplitude and pulse width of these pulses are selectable, but the pacing interval is fixed at 20 ms."2 If multiple attempts using the T-shock method are unsuccessful, 50 Hz Burst provides an additional method for inducing ventricular fibrillation. It is a less desirable method since it can result in very fine VF that is difficult to identify the initiation of possibly resulting in longer times in VF causing higher defibrillation threshold or in undersensing due to the fine nature of the rhythm.

T-shock has been found to be a fast and reliable method for inducing ventricular fibrillation in ICD implants. Greater success of inducing ventricular fibrillation using the T-shock method has been found when the energy of the T-shock was higher and the coupling interval was shorter. In addition, increasing the shock strength increases the window of vulnerability. For the T-shock method to be most efficient, initial success at inducing ventricular fibrillation, and therefore a reduced number of attempts, is important. This requires a better understanding of the optimal programmed settings for the initial T-shock induction attempt.

Moreover, in recent years, ICD indications have grown to include primary prevention patients. These patients may have different vulnerable periods than patients previously evaluated to develop Medtronic nominal settings.

Our clinical experience has found that the nominal T-shock settings are only effective at inducing ventricular fibrillation approximately seventy-five percent of the time. However, a detailed collection of success rates has not been performed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients undergoing Medtronic ICD or Cardiac Resynchronization Therapy-Defibrillator implant (initial implant or generator replacement) will be included.

Exclusion criteria

  • Any patient who is medically unstable and testing is deemed unsafe by physician will be excluded from this study.

Treatment and study plan

Nominal T shock setting

Device

Nominal Parameter Set 1 Programming Values for EnTrust

Other names: Medtronic ICDs

Educated T shock setting

Device

Experimental Parameter Set 2 Programming Values

Other names: Medtronic ICDs

Primary outcomes

  1. Sustained Ventricular Fibrillation

    Time frame: 2 hours

    The primary endpoint is the successful induction of sustained ventricular fibrillation.

Secondary outcomes

  1. Factors

    Time frame: 2 hours

    Determine if any pre-implant patient demographics are factors impacting T-shock success according to parameter settings.

Other outcomes

  1. Safety Monitoring

    Time frame: 2 hours

    Number of participants that were monitored for safety issues, including increased heart rate, blood pressure, decreased oximetry levels, and stable rhythm during the entire procedure.

Sponsors and collaborators

Lead sponsor

James Merrill

Other

Collaborators

  • Medtronic

Registry information

Official study title

Comparison of Ventricular Fibrillation Induction Techniques During Medtronic Implantable Cardioverter Defibrillator Implant

Acronym: VF

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 6, 2014
Registry last updated
May 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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