Status:
UNKNOWN
Study of Defibrillation Testing In Patients Undergoing Initial ICD Implantation
Lead Sponsor:
The Cooper Health System
Collaborating Sponsors:
Medtronic
University of Washington
Conditions:
Ventricular Arrhythmias
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 def...
Detailed Description
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 fib...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Initial ICD implantation (single, dual, or CRT) for a standard Class I or Class II indication according to the ACC/AHA/HRS practice guidelines
- Anticipated life expectancy \>6 months
Exclusion
- 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
- Contraindications to defibrillation testing include the following: hemodynamic instability, LA thrombus, atrial fibrillation without adequate anticoagulation, LV thrombus, recent CVA or TIA, severe unrevascularized coronary artery disease or unstable angina, severe aortic stenosis, inotropic dependence, patient refusal, other patient-specific medical conditions that are deemed as contraindications, as determined by the implanting physician.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01905007
Start Date
December 1 2010
End Date
December 1 2014
Last Update
July 22 2013
Active Locations (2)
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1
Cooper University Hospital
Camden, New Jersey, United States, 08103
2
University of Washington
Seattle, Washington, United States, 98195