PROTECT TAVI - Prospective Randomized Outcome Study in TAVI Patients Undergoing Periprocedural Embolic Cerebral Protection With the Sentinel™ Device

Study Overview
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Brief Summary
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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).

Official Title
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PROTECT TAVI - Prospective Randomized Outcome Study in TAVI Patients Undergoing Periprocedural Embolic Cerebral Protection With the Sentinel™ Device

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

Intervention / Treatment
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* Device: TAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien Ultra
* Device: TAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien Ultra; Sentinel™ Cerebral Protection Systems
* Device: TAVI: CoreValve® Evolut R™, CoreValve Medtronic
* Device: TAVI: CoreValve® Evolut R™, CoreValve Medtronic; Sentinel™ Cerebral Protection Systems


Participation Criteria
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Eligibility Criteria
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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): Direct outflow of left A. carotis communis out of Truncus brachiocephalicus 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: Inadequate perfusion in the area of the right upper extremity (pathologic Allen´s test, vessel obstructions, peripheral vascular disease) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: balloon-expandable TAVI without cerebral protection<br>Patient receives a balloon-expandable transcatheter aortic valve replacement without cerebral protection | Device: TAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien Ultra<br> <br> |
| Other: balloon-expandable TAVI with cerebral protection<br>Patient receives a balloon-expandable transcatheter aortic valve replacement with cerebral protection | Device: TAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien Ultra; Sentinel™ Cerebral Protection Systems<br> <br> |
| Other: self-expandable TAVI without cerebral protection<br>Patient receives a self-expandable transcatheter aortic valve replacement without cerebral protection | Device: TAVI: CoreValve® Evolut R™, CoreValve Medtronic<br> <br> |
| Other: self-expandable TAVI with cerebral protection<br>Patient receives a self-expandable transcatheter aortic valve replacement with cerebral protection | Device: TAVI: CoreValve® Evolut R™, CoreValve Medtronic; Sentinel™ Cerebral Protection Systems<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total new lesion volume in protected brain regions detected by Magnetic Resonance Imaging (MRI) |  | Day 2-4 post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aortic stenosis, transcatheter aortic valve replacement, stroke, ischemic infarction, cerebral embolic protection device