European Study Evaluating the EMBLOK Embolic Protection System During TAVR

European Study Evaluating the EMBLOK Cerebral Embolic Protection System During Transcatheter Aortic Valve Replacement (TAVR)

The primary objective is to evaluate the performance and the treatment effect of the use of the Emblok embolic protection system use during transcatheter aortic valve replacement with respect to procedure-related cerebral embolic burden as determined by DW-MRI.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Disease
• Intervention / Treatment: Procedure: Transcatheter Aortic Valve Replacement (TAVR); Device: EMBLOK filter

Detailed Description

The enrollment of up to thirty subjects with severe native aortic valve stenosis who meet clinically approved indications for transcatheter aortic valve replacement. The primary objective evaluates performance and treatment effect of the use of the EMBLOK. A secondary objective of this study is to analyze the safety profile and the type of captured debris from the Emblok filter after TAVR. Due to the small sample size, the study is not powered to detect a reduction in actual stroke rates. However, the potential risk of stroke will be assessed based on neurological evaluations pre and post procedure. In addition, silent ischemic damage and cerebral embolic burden will be assessed using DW MRI studies.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20132
    • Hospital San Raffaele
  • Milano
    • Milan, Milano, Italy, 20097
      • Hospital San Donato

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: Subject is between 18 and 90 years of age.Subject is scheduled to undergo transcatheter aortic valve replacement (TAVR) procedure on a native aortic valve and is qualified based on pre-operative trans-thoracic echocardiogram (TTE). Subject anatomy is compatible with correct device positioning with: Iliofemoral access compatible with a 12 French arterial access system for the EMBLOK catheter (> 4 mm vessel diameter). Ascending aorta length greater than or equal to 9 cm. Ascending aorta/aortic arch diameter less than or equal to 35mm.

Female subjects of child bearing potential must have a negative pregnancy test within 48 hours prior to the index study procedure.Subject agrees to comply with all study required visits. Subject or subject's legal representative completes written Informed Consent.

Exclusion Criteria: Subject requires an emergent procedure. Contraindications to MRI including: Subjects with any non-MRI compatible implantable temporary or permanent pacemaker or defibrillator, metal implants in field of view, metallic fragments, clips, or devices in the brain or eye before TAVI procedure, claustrophobia, planned implantation of non-MRI compatible pacemaker or implantable cardioverter defibrillator within 30 days after TAVR.

Subject has experienced a myocardial infarction within 30 days of the planned index procedure.

Subject has renal insufficiency, defined as a creatinine level > 2.5 mg/dl at the time of treatment.

Subject has documented history of stroke or TIA within prior 3 months. Subject has an ejection fraction of 30% or less. Subject has a history of intolerance, allergic reaction or contraindication to any of the study medications, including heparin, aspirin, clopidogrel or a sensitivity to contrast media or anesthesia which cannot be adequately pre-treated.

Subject has known allergy to any materials used in the EMBLOK device or allergy to intravascular contrast agents that cannot be pre-medicated.

Subject has active endocarditis or an ongoing systemic infection defined as fever within temperature > 38° C and/ or WBC > 15,000 IU.

Subjects undergoing therapeutic thrombolysis. Subject has history of bleeding diathesis or a major coagulopathy. Subject is known or suspected to be pregnant, or is lactating. Subject is currently participating in another drug or device clinical study, or has other medical illnesses that may cause the subject to be non-compliant with the protocol or confound the data interpretation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: TAVR + Embolic protection; subjects with severe native aortic valve stenosis who meet the commercially approved indications for transcatheter aortic valve replacement	Procedure: Transcatheter Aortic Valve Replacement (TAVR); placement of a filter to capture and remove embolic material from entering the cerebral vascular circulation during aortic valve replacement; Device: EMBLOK filter; Embolic Filter Protection System During TAVR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance Endpoint	successful insertion, placement and removal of the EMBLOK system	Day 1 to post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoint (Rate of MACCE)	Rate of MACCE	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy Endpoint	Reduction in embolic burden as measured by DW-MRI at baseline compared to post procedure 2-5 days	2-5 days

Collaborators and Investigators

• Sponsor: Innovative Cardiovascular Solutions
• Collaborators: Meditrial Europe Ltd.
• Investigators: Principal Investigator: Azeem Latib, MD, Hospital San Raffaele

Publications and helpful links

General Publications

• Latib A, Mangieri A, Vezzulli P, Spagnolo P, Sardanelli F, Fellegara G, Pagnesi M, Giannini F, Falini A, Gorla R, Montorfano M, Bedogni F, Colombo A, Popma J, Merhi WM, De Marco F. First-in-Man Study Evaluating the Emblok Embolic Protection System During Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2020 Apr 13;13(7):860-868. doi: 10.1016/j.jcin.2019.11.017.

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2017
• Primary Completion (Actual): November 1, 2021
• Study Completion (Actual): January 28, 2022

Study Registration Dates

• First Submitted: April 11, 2017
• First Submitted That Met QC Criteria: April 25, 2017
• First Posted (Actual): April 26, 2017

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Aortic Valve Disease
• Other Study ID Numbers: CLP002-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No