Optimal Antitachycardia Therapy in ICD Patients without Pacing Indications - Study code: ITAC03 Study name: OPTION Study

ELA Medical0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年6月18日

适应症

试验速览

暂无简介。

•1. Patient has been prescribed the implantation for an ICD system accordingly to the relevant currently-approved ACC/AHA guidelines1 (Appendix L) or ESC guidelines35 (Appendix M) or any relevant currently-approved local guidelines for the implantation of an ICD-system
•2. Impaired left ventricular function demonstrated by a left-ventricular ejection fraction (LVEF) <= 40 %, measured by angio-scintigraphy, echocardiography, or contrast ventriculogram.
•3. An optimal (as determined by the enrolling physician) medical regimen.
•4. Patient has received all relevant information on the study, and has signed and dated a consent form.

•1. Any generally accepted indication for standard cardiac pacing, or any contraindication for standard cardiac pacing.
•2. Any indication for CRT accordingly to the relevant currently-approved ACC/AHA1 (Appendix L) or ESC35 (Appendix M) guidelines for the implantation of a CRT system.
•3. Any contraindication for ICD therapy and the implant of a dual chamber ICD.
•4. ICD replacement
•5. Chronic atrial arrhythmias or cardioversion for atrial fibrillation within the past month.
•6. A PR interval > 250 ms or AR interval > 300 ms measured at implant.
•7. Hypertrophic obstructive cardiomyopathy.
•8. Acute myocarditis.
•9. Unstable coronary symptoms or myocardial infarction within the last month.
•10. Recent (within the last month) or planned cardiac revascularization or coronary angioplasty.
•11. recently performed (in the last month) or planned cardiac surgery
•12. Already included in another clinical study.
•13. Life expectancy less than 24 months.
•14. Inability to understand the purpose of the study or refusal to cooperate.
•15. Inability or refusal to provide informed consent and, if not part of the informed consent, a Health Insurance Portability and Accountability Act (HIPAA) authorization.
•16. Unavailability for scheduled follow-up at the implanting or cooperating center.
•17. Age of less than 18 years.
•18. Pregnancy

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