Cerebral Embolization During TAVI Using Balloon-expandable vs. Self-expandable Valves Clinical Trial
— PROTECTOfficial title:
PROTECT TAVI - Prospective Randomized Outcome Study in TAVI Patients Undergoing Periprocedural Embolic Cerebral Protection With the Sentinel™ Device
| NCT number | NCT02895737 |
| Other study ID # | 290/16s |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | December 28, 2016 |
| Est. completion date | June 2022 |
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).
| Status | Recruiting |
| Enrollment | 328 |
| Est. completion date | June 2022 |
| Est. primary completion date | December 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Deutsches Herzzentrum Muenchen, Klinik für Herz- und Gefäßchirurgie | Muenchen | Bayern |
| Lead Sponsor | Collaborator |
|---|---|
| Deutsches Herzzentrum Muenchen |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Total new lesion volume in protected brain regions detected by Magnetic Resonance Imaging (MRI) | Day 2-4 post-procedure | ||
| Secondary | Number of new cerebral lesions detected by MRI | Day 2-4 post-procedure | ||
| Secondary | Occurrence of clinical stroke and/or neurocognitive dysfunction as assessed by neurological and neurocognitive assessments | Day 2-4 post-procedure; 6 months post-procedure | ||
| Secondary | Postoperative Outcome according to the VARC 2 criteria | from operation until hospital discharge; 30-days, 6-months |