Study of Defibrillation Testing In Patients Undergoing Initial ICD Implantation

Status unconfirmed · Phase 4

Conditions studied: Ventricular Arrhythmias

In brief

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.

Key facts

Study ID

NCT01905007

Run by

The Cooper Health System

People needed

100

Starts

2010-12-01

Expected to finish

2014-12-01

Last updated by the study team

2013-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Cooper University Hospital — Camden, New Jersey, United States (enrolling)
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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