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

Primary Purpose

Cardiomyopathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nominal T shock setting
Educated T shock setting
Sponsored by
James Merrill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiomyopathy focused on measuring Defibrillators, Ventricular Fibrillation Induction Testing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wellmont CVA Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Nominal Parameter

Experimental Parameter

Arm Description

Nominal T shock setting

Educated T shock setting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 31, 2013
Last Updated
April 23, 2018
Sponsor
James Merrill
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT02027883
Brief Title
Comparison of VF Induction Techniques During Medtronic ICD Implant (VF) (ICD)
Acronym
VF
Official Title
Comparison of Ventricular Fibrillation Induction Techniques During Medtronic Implantable Cardioverter Defibrillator Implant
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
James Merrill
Collaborators
Medtronic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiomyopathy
Keywords
Defibrillators, Ventricular Fibrillation Induction Testing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nominal Parameter
Arm Type
Active Comparator
Arm Description
Nominal T shock setting
Arm Title
Experimental Parameter
Arm Type
Experimental
Arm Description
Educated T shock setting
Intervention Type
Device
Intervention Name(s)
Nominal T shock setting
Other Intervention Name(s)
Medtronic ICDs
Intervention Description
Nominal Parameter Set 1 Programming Values for EnTrust
Intervention Type
Device
Intervention Name(s)
Educated T shock setting
Other Intervention Name(s)
Medtronic ICDs
Intervention Description
Experimental Parameter Set 2 Programming Values
Primary Outcome Measure Information:
Title
Sustained Ventricular Fibrillation
Description
The primary endpoint is the successful induction of sustained ventricular fibrillation.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Factors
Description
Determine if any pre-implant patient demographics are factors impacting T-shock success according to parameter settings.
Time Frame
2 hours
Other Pre-specified Outcome Measures:
Title
Safety Monitoring
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Wellmont CVA Heart Institute
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
background
PubMed Identifier
9533375
Citation
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.
Results Reference
background
Citation
Marquis DR Reference Manual, Medtronic, Inc.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background

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

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