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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nominal Parameter | Active Comparator | Nominal T shock setting |
|
| Experimental Parameter | Experimental | Educated T shock setting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nominal T shock setting | Device | Nominal Parameter Set 1 Programming Values for EnTrust |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Ventricular Fibrillation | The primary endpoint is the successful induction of sustained ventricular fibrillation. | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Factors | Determine if any pre-implant patient demographics are factors impacting T-shock success according to parameter settings. | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wellmont CVA Heart Institute | Kingsport | Tennessee | 37660 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Bardy G, Mehra R, Johnson G, Kudenchuk P, Dolack G, Poole J, Hofer B: Low energy pulsing on the T-wave: A new programming method for intentional, device mediated induction of ventricular fibrillation for defibrillation testing. PACE 15(4, Pt II): 562, 1992. | ||
| 9533375 | Background | Bhandari AK, Isber N, Estioko M, Ziccardi T, Cannom DS, Park Y, Lerman RD, Prejean C, Sun GW. Efficacy of low-energy T wave shocks for induction of ventricular fibrillation in patients with implantable cardioverter defibrillators. J Electrocardiol. 1998 Jan;31(1):31-7. doi: 10.1016/s0022-0736(98)90004-8. | |
| Background | Marquis DR Reference Manual, Medtronic, Inc. | ||
| Background | Mitchell L, Yee R, Talajic M, Newman D, Sheldon R, Kerr C, Kus T, Boyle A, Canadian Jewel PCD Investigators: Low-energy, T-wave synchronous, interval shock for rapid, reliable ventricular fibrillation induction by an implantable cardioverter defibrllattor. PACE, 17(4, Pt II): 851, 1994. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nominal Parameter | Nominal T shock setting Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust |
| FG001 | Experimental Parameter | Educated T shock setting Educated T shock setting: Experimental Parameter Set 2 Programming Values |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nominal Parameter | Nominal T shock setting Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust |
| BG001 | Experimental Parameter | Educated T shock setting Educated T shock setting: Experimental Parameter Set 2 Programming Values |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sustained Ventricular Fibrillation | The primary endpoint is the successful induction of sustained ventricular fibrillation. | Posted | Number | participants | 2 hours |
|
|
The patient's were observed for adverse events from the time of consent to the time they met the primary endpoint.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nominal Parameter | Nominal T shock setting Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Terrie Walker, Director of Clinical Research | Wellmont CVA Heart Institute | 423-230-5643 | twalker@mycva.com |
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| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Educated T shock setting | Device | Experimental Parameter Set 2 Programming Values |
|
|
| Background | Swartz J, Stanton M, DeGroot P, Mehra R: Influence of T-wave shock energy on ventricular fibrillation vulnerability in humans. JACC 1995 Conference Abstracts: 214A, 1995. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| VF Induction amount of participants | Number of subjects that participated in the VF induction study protocol. | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Factors | Determine if any pre-implant patient demographics are factors impacting T-shock success according to parameter settings. | Posted | Number | participants | 2 hours |
|
|
|
| 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. | Posted | Number | participants | 2 hours |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Experimental Parameter | Educated T shock setting Educated T shock setting: Experimental Parameter Set 2 Programming Values | 0 | 50 | 0 | 50 |
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| Unsuccessful Male Participants |
|
| Unsuccessful Female Participants |
|