PROTECT TAVI - Prospective Randomized Outcome Study in TAVI Patients Undergoing Periprocedural Embolic Cerebral Protection With the Sentinel™ Device
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: balloon-expandable TAVI without cerebral protection Patient receives a balloon-expandable transcatheter aortic valve replacement without cerebral protection |
Device: TAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien Ultra
|
| Other: balloon-expandable TAVI with cerebral protection 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
|
| Other: self-expandable TAVI without cerebral protection Patient receives a self-expandable transcatheter aortic valve replacement without cerebral protection |
Device: TAVI: CoreValve® Evolut R™, CoreValve Medtronic
|
| Other: self-expandable TAVI with cerebral protection Patient receives a self-expandable transcatheter aortic valve replacement with cerebral protection |
Device: TAVI: CoreValve® Evolut R™, CoreValve Medtronic; Sentinel™ Cerebral Protection Systems
|
Outcome Measures
Primary Outcome Measures
- Total new lesion volume in protected brain regions detected by Magnetic Resonance Imaging (MRI) [Day 2-4 post-procedure]
Secondary Outcome Measures
- 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]
Eligibility Criteria
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):
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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:
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Apoplexy/ TIA during the last ½ year
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Severe carotid stenosis (>70%)
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Symptomatic or asymptomatic carotid stenosis with necessity of TEA or stenting
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Relevant psychiatric diseases
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Severe/ relevant visual, auditory or cognitive deficits which impede targeted anamnesis, neurologic evaluation or consenting.
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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
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Significant stenosis, relevant calcifications, dissections or aneurysmatic alterations in the area of Truncus brachiocephalicus and/or A. carotis communis sinistra.
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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.
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Vessel alterations which impede among others the introduction of a 6 French sheath:
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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
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Acute myocardial infarction ≤ 1 month prior to the planned procedure
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Every contraindication for the execution of a transfemoral TAVI
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Aortic annulus <19 or >29 mm
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Combined aortic vitium with predominant insufficiency.
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Severly reduced leftventricular function ≤ 20%
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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
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Intracardiac thrombus, hematoma, tumor or vegetations confirmed by echocardiography
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Endocarditis
-
Planned concomitant procedure for atrial fibrillation (operative or via catheter ablation) during the follow up phase
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Need for emergency procedure
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Chronic drug-, medication or alcohol abuse
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Consuming disease
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Life expectancy < 1 year
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Dialysis dependency
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Deutsches Herzzentrum Muenchen, Klinik für Herz- und Gefäßchirurgie | Muenchen | Bayern | Germany | 80636 |
Sponsors and Collaborators
- Deutsches Herzzentrum Muenchen
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 290/16s