protect tavi - prospective randomized outcome study in tavi patients undergoing periprocedural embolic cerebral protection with the sentinel™ device

Conditions: Cerebral Embolization During TAVI Using Balloon-expandable vs. Self-expandable Valves

Summary: this prospective, randomized study was designed to analyse the difference of cerebral embolization in patients undergoing transcatheter aortic valve implantation with balloon-expandable vs. self-expandable valves by using a cerebral protection system (sentinel™ device).


Eligibility criteria:
inclusion criteria: * patients with aortic stenosis and indication for transfemoral aortic valve replacement * freedom of significant stenosis in the area of truncus brachiocephalicus and left a. carotis (ct) * necessary vessel diameter of 6.5-10 mm in the area of a. carotis communis sinistra and 9-15 mm in the area of truncus brachiocephalicus (for delivery of protection system) * anomalies of aortic arch ("bovine arch" variants): 1. direct outflow of left a. carotis communis out of truncus brachiocephalicus 2. conjoint origin of truncus brachiocephalicus and left a. carotis communis out of aortic arch * the patient has provided written informed consent exclusion criteria: * apoplexy/ tia during the last ½ year * severe carotid stenosis (\>70%) * symptomatic or asymptomatic carotid stenosis with necessity of tea or stenting * relevant psychiatric diseases * severe/ relevant visual, auditory or cognitive deficits which impede targeted anamnesis, neurologic evaluation or consenting. * severe neurodegenerative or progressive neuromuscular disease and state after severe craniocerebral injury with permanent neurologic sequelae and structural cerebral diseases * pronounced kinking/ stenosis or calcification in the area of the right a. radialis/ brachialis/ subclavia, which impede implantation of the cerebral protection system * significant stenosis, relevant calcifications, dissections or aneurysmatic alterations in the area of truncus brachiocephalicus and/or a. carotis communis sinistra. * contraindications for mri: among others the presence of a non-mri-compatible pacemaker or defibrillator, metal implants in the area to be evaluated, metal fragments in the craniocerebral area, allergies, claustrophobia. * vessel alterations which impede among others the introduction of a 6 french sheath: 1. inadequate perfusion in the area of the right upper extremity (pathologic allen´s test, vessel obstructions, peripheral vascular disease) 2. hemodialysis shunt, grafts, or arteriovenous fistulas in the area of right upper extremity * acute myocardial infarction ≤ 1 month prior to the planned procedure * every contraindication for the execution of a transfemoral tavi * aortic annulus \ 29 mm * combined aortic vitium with predominant insufficiency. * severly reduced leftventricular function ≤ 20% * patients who are planned for a hybrid procedure (e.g. conventional operation and tavi or simultaneous coronary intervention at coronary artery disease needing intervention) 14 days prior to the planned study procedure * intracardiac thrombus, hematoma, tumor or vegetations confirmed by echocardiography * endocarditis * planned concomitant procedure for atrial fibrillation (operative or via catheter ablation) during the follow up phase * need for emergency procedure * chronic drug-, medication or alcohol abuse * consuming disease * life expectancy \< 1 year * dialysis dependency * patient with legal incapacity, who is not able to understand the essence, meaning and consequences of the study * participation in other interventional clinical trials in the month of study start or planned participation during the participation of this study

Keywords: aortic stenosis, transcatheter aortic valve replacement, stroke, ischemic infarction, cerebral embolic protection device