Status:
COMPLETED
Optimal Anti-tachycardia Therapy in Implantable Cardioverter-defibrillator (ICD) Patients Without Pacing Indications
Lead Sponsor:
LivaNova
Conditions:
Tachycardia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study evaluates the impact of a new pacing mode avoiding unnecessary ventricular stimulation in combination with advanced dual chamber detection with slow VT management on the clinical outcome fo...
Detailed Description
All patients will receive an implantable cardioverter defibrillator OVATIO™ DR model 6550 or a later Sorin Group device offering the same functions. After Enrolment visit but before implant, patients ...
Eligibility Criteria
Inclusion
- Patient has been prescribed the implantation for an ICD system accordingly to the relevant currently-approved ACC/AHA guidelines 1 or ESC guidelines 35 or any relevant currently-approved local guidelines for the implantation of an ICD-system
- Impaired left ventricular function demonstrated by a left-ventricular ejection fraction (LVEF) ≤ 40 %, measured by angio-scintigraphy, echocardiography, or contrast ventriculogram.
- An optimal (as determined by the enrolling physician) medical regimen.
- Patient has received all relevant information on the study, and has signed and dated a consent form.
Exclusion
- Any generally accepted indication for standard cardiac pacing, or any contraindication for standard cardiac pacing.
- Any indication for CRT accordingly to the relevant currently-approved ACC/AHA1 or ESC35 guidelines for the implantation of a CRT system.
- Any contraindication for ICD therapy and the implant of a dual chamber ICD.
- ICD replacement
- Chronic atrial arrhythmias or cardioversion for atrial fibrillation within the past month.
- A PR interval \> 250 ms or AR interval \> 300 ms measured at implant.
- Hypertrophic obstructive cardiomyopathy.
- Acute myocarditis.
- Unstable coronary symptoms or myocardial infarction within the last month.
- Recent (within the last month) or planned cardiac revascularization or coronary angioplasty.
- Recently performed (in the last month) or planned cardiac surgery
- Already included in another clinical study.
- Life expectancy less than 24 months.
- Inability to understand the purpose of the study or refusal to cooperate.
- Inability or refusal to provide informed consent and, if not part of the informed consent, a Health Insurance Portability and Accountability Act (HIPAA) authorization.
- Unavailability for scheduled follow-up at the implanting or cooperating center.
- Age of less than 18 years.
- Pregnancy
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
462 Patients enrolled
Trial Details
Trial ID
NCT00729703
Start Date
June 1 2006
End Date
October 1 2013
Last Update
January 13 2015
Active Locations (55)
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1
Piedmont Hospital Research Institute
Atlanta, Georgia, United States, 30303
2
Atlanta Va Medical Center
Decatur, Georgia, United States, 30301
3
Southern Medical Research, Llc
Mandeville, Louisiana, United States, 70471
4
River City Cardiology
Jeffersonville, Ohio, United States, 43128