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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02027883
Acronym
VF
Enrollment
100
Registered
2014-01-06
Start date
2011-01-31
Completion date
2012-08-31
Last updated
2018-05-22

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

Conditions

Cardiomyopathy

Keywords

Defibrillators, Ventricular Fibrillation Induction Testing

Brief summary

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.

Detailed description

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.

Interventions

DEVICENominal T shock setting

Nominal Parameter Set 1 Programming Values for EnTrust

DEVICEEducated T shock setting

Experimental Parameter Set 2 Programming Values

Sponsors

Medtronic
CollaboratorINDUSTRY
James Merrill
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Sustained Ventricular Fibrillation2 hoursThe primary endpoint is the successful induction of sustained ventricular fibrillation.

Secondary

MeasureTime frameDescription
Factors2 hoursDetermine if any pre-implant patient demographics are factors impacting T-shock success according to parameter settings.

Other

MeasureTime frameDescription
Safety Monitoring2 hoursNumber of participants that were monitored for safety issues, including increased heart rate, blood pressure, decreased oximetry levels, and stable rhythm during the entire procedure.

Countries

United States

Participant flow

Participants by arm

ArmCount
Nominal Parameter
Nominal T shock setting Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust
50
Experimental Parameter
Educated T shock setting Educated T shock setting: Experimental Parameter Set 2 Programming Values
50
Total100

Baseline characteristics

CharacteristicNominal ParameterExperimental ParameterTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
23 Participants32 Participants55 Participants
Age, Categorical
Between 18 and 65 years
27 Participants18 Participants45 Participants
Age, Continuous61.82 years
STANDARD_DEVIATION 13.68403
66.68 years
STANDARD_DEVIATION 10.51809
64.25 years
STANDARD_DEVIATION 12.38554
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
50 Participants50 Participants100 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
50 Participants50 Participants100 Participants
Region of Enrollment
United States
50 participants50 participants100 participants
Sex: Female, Male
Female
12 Participants10 Participants22 Participants
Sex: Female, Male
Male
38 Participants40 Participants78 Participants
VF Induction amount of participants50 participants50 participants100 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 500 / 50
serious
Total, serious adverse events
0 / 500 / 50

Outcome results

Primary

Sustained Ventricular Fibrillation

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

Time frame: 2 hours

ArmMeasureValue (NUMBER)
Nominal ParameterSustained Ventricular Fibrillation38 participants
Experimental ParameterSustained Ventricular Fibrillation35 participants
Secondary

Factors

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

Time frame: 2 hours

ArmMeasureGroupValue (NUMBER)
Nominal ParameterFactorsSuccessful Male Participants30 participants
Nominal ParameterFactorsSuccessful Female participants8 participants
Nominal ParameterFactorsUnsuccessful Male Participants8 participants
Nominal ParameterFactorsUnsuccessful Female Participants4 participants
Experimental ParameterFactorsUnsuccessful Female Participants3 participants
Experimental ParameterFactorsSuccessful Male Participants28 participants
Experimental ParameterFactorsUnsuccessful Male Participants12 participants
Experimental ParameterFactorsSuccessful Female participants7 participants
Other Pre-specified

Safety Monitoring

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.

Time frame: 2 hours

ArmMeasureValue (NUMBER)
Nominal ParameterSafety Monitoring50 participants
Experimental ParameterSafety Monitoring50 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026