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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
| University of Washington | OTHER |
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The primary objective of this study is to compare the composite outcome of total mortality and operative complications in patients who do not undergo defibrillation testing to those who do undergo defibrillation testing at the time of initial ICD implantation.
Implantable cardioverter-defibrillators (ICDs) are the most effective treatment for the primary and secondary prevention of sudden cardiac death (SCD). At the time of ICD implantation, ventricular fibrillation (VF) is typically induced to demonstrate effective arrhythmia termination by the implanted device. Although defibrillation threshold (DFT) testing with induction of VF at time of ICD insertion is currently considered the "standard of care," and instructions for usage of devices approved by the Food and Drug Administration (FDA) include labeling with DFT testing, the value of defibrillation testing with modern-day devices has been questioned. Defibrillation testing can be associated with serious complications and may add to the cost of the procedure.
It is hypothesized that patients who do not undergo defibrillation testing will have outcomes similar to those who do undergo defibrillation testing at the time of initial implantation. This pilot study is being performed to determine the feasibility of performing a larger, multi-center clinical trial with longer follow-up to investigate whether or not defibrillation testing will have any impact on overall mortality, implant complications, or long-term first shock efficacy during clinical follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Defibrillation testing | Active Comparator | Defibrillation testing at initial ICD implantation |
|
| No defibrillation testing | No Intervention | No defibrillation testing at initial ICD implantation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Defibrillation testing | Device | Defibrillation testing at initial ICD implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite all-cause mortality and operative complications | The composite endpoint of implant complications and mortality rates will be compared in the DFT vs. no DFT groups. | Procedure-related complications will be defined as those occurring within 90 days post-implantation and mortality will be measured at 2 year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 1st shock efficacy for clinical occurrence of ventricular tachycardia (VT)/VF | The efficacy of 1st shock therapy for VT/VF will be compared between the DFT and no DFT groups. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
Contraindications to defibrillation testing as determined by the managing physician*
ICD replacement implants
Right-sided pectoral implants
Abdominal implants
Chronic oral amiodarone therapy (for >6 weeks and continued need for amiodarone)
Inability to give informed consent
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea M. Russo, MD | Contact | 856-968-7096 | russo-andrea@cooperhealth.edu | |
| Julie Field | Contact | 856-669-8847 | field-julie@cooperhealth.edu |
| Name | Affiliation | Role |
|---|---|---|
| Andrea M. Russo, MD | The Cooper Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cooper University Hospital | Recruiting | Camden | New Jersey | 08103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15840466 | Background | Russo AM, Sauer W, Gerstenfeld EP, Hsia HH, Lin D, Cooper JM, Dixit S, Verdino RJ, Nayak HM, Callans DJ, Patel V, Marchlinski FE. Defibrillation threshold testing: is it really necessary at the time of implantable cardioverter-defibrillator insertion? Heart Rhythm. 2005 May;2(5):456-61. doi: 10.1016/j.hrthm.2005.01.015. | |
| 17461879 |
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| University of Washington | Not yet recruiting | Seattle | Washington | 98195 | United States |
|
| Swerdlow CD, Russo AM, Degroot PJ. The dilemma of ICD implant testing. Pacing Clin Electrophysiol. 2007 May;30(5):675-700. doi: 10.1111/j.1540-8159.2007.00730.x. |
| 16945792 | Background | Mainigi SK, Cooper JM, Russo AM, Nayak HM, Lin D, Dixit S, Gerstenfeld EP, Hsia HH, Callans DJ, Marchlinski FE, Verdino RJ. Elevated defibrillation thresholds in patients undergoing biventricular defibrillator implantation: incidence and predictors. Heart Rhythm. 2006 Sep;3(9):1010-6. doi: 10.1016/j.hrthm.2006.05.028. Epub 2006 Jun 15. |
| 18687249 | Background | Blatt JA, Poole JE, Johnson GW, Callans DJ, Raitt MH, Reddy RK, Marchlinski FE, Yee R, Guarnieri T, Talajic M, Wilber DJ, Anderson J, Chung K, Wong WS, Mark DB, Lee KL, Bardy GH; SCD-HeFT Investigators. No benefit from defibrillation threshold testing in the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial). J Am Coll Cardiol. 2008 Aug 12;52(7):551-6. doi: 10.1016/j.jacc.2008.04.051. |
| 18243813 | Background | Birnie D, Tung S, Simpson C, Crystal E, Exner D, Ayala Paredes FA, Krahn A, Parkash R, Khaykin Y, Philippon F, Guerra P, Kimber S, Cameron D, Healey JS. Complications associated with defibrillation threshold testing: the Canadian experience. Heart Rhythm. 2008 Mar;5(3):387-90. doi: 10.1016/j.hrthm.2007.11.018. Epub 2007 Nov 28. |
| 16533250 | Background | Pires LA, Johnson KM. Intraoperative testing of the implantable cardioverter-defibrillator: how much is enough? J Cardiovasc Electrophysiol. 2006 Feb;17(2):140-5. doi: 10.1111/j.1540-8167.2005.00294.x. |