Advanced Image Supported Lef ventricular Lead Placement in Cardiac Resynchronization Therapy - Advise-CRT

niversitair Medisch Centrum Utrecht0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年4月23日

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•An indication Cardiac Resynchronization Therapy according to the current international evidence based guidelines for CRT (the 2013 European Society of Cardiology Guidelines for cardiac pacing and cardiac resynchronization therapy):
•-Chronic heart failure;
•-New York Heart Association functional class II, III, IV (ambulatory);
•-QRS duration *120ms;
•-Optimal pharmacological therapy;
•-Left ventricular ejection fraction *35%;;And specifically for phase 1 of the study:
•-Documented history of myocardial infarction, coronary artery disease, or delayed enhancement on a prior MRI.

•-Contraindications for implantation of a CRT device;
•-Age <18 years or incapacitated adult;
•-Pregnancy; if there is anamnestic doubt regarding postmenopausal state (<1 year since last menstruation), an urine hCG test (Alere) will be performed.
•-Lactation;
•-Impaired renal function (severe renal insufficiency, GFR < 30 ml/min/1.73m2);
•-Permanent atrial fibrillation or atrial fibrillation during MRI
•-Documented allergic reaction to gadolinium;
•-Documented allergic reaction to contrast agent;
•-Impossibility to undergo a MRI scan (determined by using the standard contraindications for MR imaging as used for clinical purposes).
•-Participation in another clinical study that prohibits any procedures other than standard. ;After study MRI:
•- No delayed enhancement on MRI

发起方

niversitair Medisch Centrum Utrecht