Cerebral Embolization During TAVI Using Balloon-expandable vs. Self-expandable Valves
Conditions
Keywords
aortic stenosis, transcatheter aortic valve replacement, stroke, ischemic infarction, cerebral embolic protection device
Brief 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).
Interventions
DEVICETAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien Ultra
DEVICETAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien Ultra; Sentinel™ Cerebral Protection Systems
DEVICETAVI: CoreValve® Evolut R™, CoreValve Medtronic
DEVICETAVI: CoreValve® Evolut R™, CoreValve Medtronic; Sentinel™ Cerebral Protection Systems
Sponsors
Deutsches Herzzentrum Muenchen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 \<19 or \>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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total new lesion volume in protected brain regions detected by Magnetic Resonance Imaging (MRI) | Day 2-4 post-procedure |
Secondary
| Measure | Time frame |
|---|---|
| Number of new cerebral lesions detected by MRI | Day 2-4 post-procedure |
| Occurrence of clinical stroke and/or neurocognitive dysfunction as assessed by neurological and neurocognitive assessments | Day 2-4 post-procedure; 6 months post-procedure |
| Postoperative Outcome according to the VARC 2 criteria | from operation until hospital discharge; 30-days, 6-months |
Countries
Germany
Contacts
Primary ContactStephanie Voss, Dr.
Outcome results
None listed