NCT05873816

Brief Summary

The goal of this prospective, multi-center, randomized, controlled study is to compare the safety and efficacy of the ProtEmbo Cerebral Embolic Protection device to a hybrid control (no embolic protection device ('No Device') and the Sentinel device) in subjects with severe symptomatic native aortic valve stenosis indicated undergoing a TAVR procedure.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
284

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
3 countries

20 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

First Submitted

Initial submission to the registry

May 15, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

March 21, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

1.6 years

First QC Date

May 15, 2023

Last Update Submit

January 7, 2026

Conditions

Severe Aortic Valve Stenosis

Keywords

TAVRCerebral embolic protection

Outcome Measures

Primary Outcomes (2)

  • MACCE at 30 days

    Occurrence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 days defined as all-cause mortality, all stroke, life-threatening or disabling bleeding, major vascular complications, and acute kidney injury (stage 2 or 3) as defined by VARC-3.

    Up to Day 30 post procedure

  • Total new lesion volume

    Total new lesion volume (TNLV) in the brain assessed by diffusion weighted magnetic resonance imaging (DW-MRI) at 36 ±12 hours.

    36 ±12 hours post TAVR procedure

Study Arms (3)

ProtEmbo - Cerebral Embolic Protection

EXPERIMENTAL

Subjects will undergo TAVR following placement of the ProtEmbo cerebral embolic protection device.

Device: ProtEmbo - Cerebral Embolic Protection

Sentinel - Cerebral Embolic Protection

ACTIVE COMPARATOR

Subjects will undergo TAVR following placement of the Sentinel cerebral embolic protection device.

Device: Sentinel - Cerebral Embolic Protection

Control Arm

NO INTERVENTION

Subjects will undergo TAVR without embolic protection.

Interventions

Sentinel - Cerebral Embolic ProtectionDEVICE

Subjects will undergo TAVR following placement of the Sentinel cerebral embolic protection device.

Sentinel - Cerebral Embolic Protection
ProtEmbo - Cerebral Embolic ProtectionDEVICE

Subjects will undergo TAVR following placement of the ProtEmbo cerebral embolic protection device.

ProtEmbo - Cerebral Embolic Protection

Eligibility Criteria

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

You may qualify if:

  • The heart team recommends transcatheter aortic valve replacement via femoral access consistent with the 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease.
  • The subject and the treating physician agree that the subject will undergo the scheduled pre procedural testing and return for all required post procedure follow up visits.
  • The subject is able to provide informed consent, has been informed of the nature of the trial, agrees to its provisions and has provided written informed consent as approved by the relevant regulatory authority of the respective clinical site.
  • Subject is a minimum of 18 years of age.

You may not qualify if:

  • Subject is a woman of child-bearing potential.
  • Arm anatomy/ vasculature precluding radial or brachial artery access.
  • Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity vasculature.
  • Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment.
  • Severe ventricular dysfunction with LVEF ≤25%.
  • Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 10 days of the index procedure.
  • Blood dyscrasias as defined by clinically significant leukopenia (\< 500 leukocytes / μL), acute anemia (Hgb \< 8 g / dL), thrombocytopenia (\< 80,000 platelets / μl), history of bleeding diathesis or coagulopathy.
  • Hemodynamic instability, or pressure dependence requiring pharmacological inotropic support or mechanical heart assistance.
  • Echocardiographic evidence of intracardiac or aortic mass, thrombus not adequately treated, or vegetation.
  • Active peptic ulcer or upper GI bleeding within the prior 6 months.
  • Contraindication for anticoagulant or antiplatelet therapy.
  • Renal insufficiency (creatinine \> 3.0 mg / dL or GFR \< 30) and / or renal replacement therapy at the time of screening and dialysis patients.
  • Current or planned treatment with any investigational drug or investigational device during the study follow-up period (30 days).
  • Balloon aortic valvuloplasty (BAV) within 30 days of the procedure.
  • Cardiogenic shock, hemodynamic instability, or severe hypotension (systolic blood pressure \< 90 mm Hg) at the time of the index procedure.
  • +23 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Tucson Medical Center Health

Tucson, Arizona, 85712, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

BayCare Health System / Morton Plant Hospital

Clearwater, Florida, 33756, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Saint Luke&#39;s Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Washington University - St. Louis

St Louis, Missouri, 63110, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07690, United States

Location

State University of New York at Buffalo

Buffalo, New York, 14203, United States

Location

NYU Langone

New York, New York, 10016, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Columbia University Medical Center / NYPH

New York, New York, 10032, United States

Location

Weill Medical College / Cornell University

New York, New York, 10065, United States

Location

University of Texas, Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

University of Virginia, Charlottesville

Charlottesville, Virginia, 22908, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Dresden Herzzentrum

Dresden, 01307, Germany

Location

Lübeck Universitätsklinikum Schleswig-Holstein Campus

Lübeck, 23562, Germany

Location

Trier Krankenhaus der Barmherzigen Brüder

Trier, 54292, Germany

Location

Ulm Universitätsklinikum

Ulm, 89081, Germany

Location

Gdansk Uniwersyteckie Centrum Kliniczne

Gdansk, 80-214, Poland

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Roxana Mehran, MD

    Icahn School of Medicine at Mount Sinai

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2023

First Posted

May 24, 2023

Study Start

March 21, 2024

Primary Completion

October 18, 2025

Study Completion

December 31, 2025

Last Updated

January 9, 2026

Record last verified: 2026-01

Locations

US(15)DE(4)PL(1)