Cardiomyopathy
Conditions
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
Nominal Parameter Set 1 Programming Values for EnTrust
Experimental Parameter Set 2 Programming Values
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Sustained Ventricular Fibrillation | 2 hours | The primary endpoint is the successful induction of sustained ventricular fibrillation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Factors | 2 hours | Determine if any pre-implant patient demographics are factors impacting T-shock success according to parameter settings. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety Monitoring | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 100 |
Baseline characteristics
| Characteristic | Nominal Parameter | Experimental Parameter | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 23 Participants | 32 Participants | 55 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 18 Participants | 45 Participants |
| Age, Continuous | 61.82 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 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants | 50 Participants | 100 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 50 Participants | 50 Participants | 100 Participants |
| Region of Enrollment United States | 50 participants | 50 participants | 100 participants |
| Sex: Female, Male Female | 12 Participants | 10 Participants | 22 Participants |
| Sex: Female, Male Male | 38 Participants | 40 Participants | 78 Participants |
| VF Induction amount of participants | 50 participants | 50 participants | 100 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Sustained Ventricular Fibrillation
The primary endpoint is the successful induction of sustained ventricular fibrillation.
Time frame: 2 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nominal Parameter | Sustained Ventricular Fibrillation | 38 participants |
| Experimental Parameter | Sustained Ventricular Fibrillation | 35 participants |
Factors
Determine if any pre-implant patient demographics are factors impacting T-shock success according to parameter settings.
Time frame: 2 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nominal Parameter | Factors | Successful Male Participants | 30 participants |
| Nominal Parameter | Factors | Successful Female participants | 8 participants |
| Nominal Parameter | Factors | Unsuccessful Male Participants | 8 participants |
| Nominal Parameter | Factors | Unsuccessful Female Participants | 4 participants |
| Experimental Parameter | Factors | Unsuccessful Female Participants | 3 participants |
| Experimental Parameter | Factors | Successful Male Participants | 28 participants |
| Experimental Parameter | Factors | Unsuccessful Male Participants | 12 participants |
| Experimental Parameter | Factors | Successful Female participants | 7 participants |
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nominal Parameter | Safety Monitoring | 50 participants |
| Experimental Parameter | Safety Monitoring | 50 participants |