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

German Heart Center Munich

Status: Unknown

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02895737

290/16s

Details and patient eligibility

About

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).

Enrollment: 328 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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328 participants in 4 patient groups

balloon-expandable TAVI without cerebral protection

Other group

Description:

Patient receives a balloon-expandable transcatheter aortic valve replacement without cerebral protection

Treatment:

Device: TAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien Ultra

balloon-expandable TAVI with cerebral protection

Other group

Description:

Patient receives a balloon-expandable transcatheter aortic valve replacement with cerebral protection

Treatment:

Device: TAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien Ultra; Sentinel™ Cerebral Protection Systems

self-expandable TAVI without cerebral protection

Other group

Description:

Patient receives a self-expandable transcatheter aortic valve replacement without cerebral protection

Treatment:

Device: TAVI: CoreValve® Evolut R™, CoreValve Medtronic

self-expandable TAVI with cerebral protection

Other group

Description:

Patient receives a self-expandable transcatheter aortic valve replacement with cerebral protection

Treatment:

Device: TAVI: CoreValve® Evolut R™, CoreValve Medtronic; Sentinel™ Cerebral Protection Systems