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

Not Applicable

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

• Registration Number: NCT02895737
• Lead Sponsor: Deutsches Herzzentrum Muenchen

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-06
• Study First Submitted QC: 2016-09-06
• Study First Posted: 2016-09-12
• Study Start: 2016-12-28
• Status Verified: 2021-01
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-04
• Primary Completion: 2021-12
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 328

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total new lesion volume in protected brain regions detected by Magnetic Resonance Imaging (MRI)	Day 2-4 post-procedure

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Deutsches Herzzentrum Muenchen, Klinik für Herz- und Gefäßchirurgie; 🇩🇪 Muenchen, Bayern, Germany