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

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).

Study Overview

• Status: Recruiting
• Conditions: Cerebral Embolization During TAVI Using Balloon-expandable vs. Self-expandable Valves
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Anticipated): 328
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephanie Voss, Dr.; Phone Number: 0049 89 1218 0; Email: VossS@dhm.mhn.de

Study Locations

• Germany
  • Bayern
    • Muenchen, Bayern, Germany, 80636
      • Recruiting
      • Deutsches Herzzentrum Muenchen, Klinik für Herz- und Gefäßchirurgie
      • Contact: Stephanie Voss, Dr.; Phone Number: 00498912180

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Deutsches Herzzentrum Muenchen

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2016
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: September 6, 2016
• First Submitted That Met QC Criteria: September 6, 2016
• First Posted (Estimate): September 12, 2016

Study Record Updates

• Last Update Posted (Actual): March 4, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: aortic stenosis, transcatheter aortic valve replacement, stroke, ischemic infarction, cerebral embolic protection device
• Other Study ID Numbers: 290/16s