NCT03130491

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 8, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 11, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 26, 2017

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2022

Completed
Last Updated

March 5, 2024

Status Verified

September 1, 2023

Enrollment Period

4.7 years

First QC Date

April 11, 2017

Last Update Submit

March 4, 2024

Conditions

Aortic Valve Disease

Outcome Measures

Primary Outcomes (1)

  • Performance Endpoint

    successful insertion, placement and removal of the EMBLOK system

    Day 1 to post procedure

Secondary Outcomes (1)

  • Safety Endpoint (Rate of MACCE)

    30 days

Other Outcomes (1)

  • Efficacy Endpoint

    2-5 days

Study Arms (1)

TAVR + Embolic protection

OTHER

subjects with severe native aortic valve stenosis who meet the commercially approved indications for transcatheter aortic valve replacement

Procedure: Transcatheter Aortic Valve Replacement (TAVR)Device: EMBLOK filter

Interventions

Transcatheter Aortic Valve Replacement (TAVR)PROCEDURE

placement of a filter to capture and remove embolic material from entering the cerebral vascular circulation during aortic valve replacement

TAVR + Embolic protection
EMBLOK filterDEVICE

Embolic Filter Protection System During TAVR

TAVR + Embolic protection

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital San Donato

Milan, Milano, 20097, Italy

Location

Hospital San Raffaele

Milan, 20132, Italy

Location

Related Publications (1)

  • 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.

    PMID: 32273098DERIVED

MeSH Terms

Conditions

Aortic Valve Disease

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis ImplantationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationThoracic Surgical Procedures

Study Officials

  • Azeem Latib, MD

    Hospital San Raffaele

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2017

First Posted

April 26, 2017

Study Start

March 8, 2017

Primary Completion

November 1, 2021

Study Completion

January 28, 2022

Last Updated

March 5, 2024

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(2)