Protect the Head to Head Study

NCT05684146 | Unknown Phase 2 DMC FDA Device

• 1 other identifier: TP-0527
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 2

Brief Summary

Prospective, randomized, open label, multicenter, 2-arm, safety and efficacy study

Conditions

Embolism

Keywords

MACCE; TAVR; Embolism

Outcome Measures

Primary Outcomes (1)

• Non-inferiority

  Non-inferiority of 30-day Emboliner device MACCE patient incidence rate compared to the Sentinel device patient incidence rate. K4: Description Non-inferiority of 30-day Emboliner device MACCE patient incidence rate compared to the Sentinel device patient incidence rate. 30 Days

  Non-inferiority of 30-day Emboliner device MACCE patient incidence rate compared to the Sentinel device patient incidence rate.

Secondary Outcomes (2)

• Non-inferiority VARC-2

  30 Days

• Debris Capture

  30 Days

Study Arms (2)

Emboliner Embolic Protection Device

EXPERIMENTAL

Emboliner embolic protection device to be used during TAVR procedures for stroke prevention

Device: Emboliner Embolic Protection

Sentinel Cerebral Protection System

ACTIVE COMPARATOR

Sentinel Cerebral Protection System to be used during TAVR procedures for stroke prevention

Device: Sentinel Cerebral Protection

Interventions

Emboliner Embolic Protection DEVICE

Emboliner Embolic Protection Device will be used to capture and remove embolic material during transcatheter aortic valve replacement (TAVR) interventions

Also known as: Embolic protection

Emboliner Embolic Protection Device

Sentinel Cerebral Protection DEVICE

The Sentinel Cerebral Protection System will be used to capture and remove embolic material during transcatheter aortic valve replacement (TAVR) interventions

Also known as: Embolic protection

Sentinel Cerebral Protection System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible for treatment for symptomatic severe aortic stenosis using a FDA-approved TAVR valve according to current guidelines
• Consented to the TAVR procedure
• Subject and physician agree that subject will return for required post-procedure follow-up
• Willing to participate in study and provide signed EC/IRB-approved informed consent
• Eighteen (18) years or older at the time of consent

You may not qualify if:

• Not undergoing a planned TAVR via transfemoral access
• Severe allergy or hypersensitivity to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, nitinol, and/or contrast agents that cannot be pre-medicated
• Uncorrected bleeding disorder
• Hypercoagulation status that cannot be corrected by additional peri-procedural heparin
• Myocardial infarction (MI) diagnosis \<30 days prior to study procedure
• History of substance abuse that may cause non-compliance with the protocol or confound the data interpretation
• Cardiogenic shock, hemodynamic instability requiring inotropic support or mechanical heart assistance, or severe hypotension (systolic blood pressure \<90 mmHg) at time of screening
• History of a stroke \< 180 days prior to study procedure
• Active peptic ulcer or history of upper gastrointestinal (GI) bleeding \< 90 days prior to study procedure
• Congenital unicuspid aortic valve
• Porcelain aorta, asymmetrical or sharp aortic calcifications, severe aortic tortuosity, shaggy aorta or mobile atheroma in the arch
• Pre-existing prosthetic heart valve in any position, prosthetic ring, or severe (greater than 3+) mitral insufficiency
• Current leukopenia, acute anemia, thrombocytopenia, history of chronic bleeding diathesis, or coagulopathy that requires treatment
• Hypertrophic cardiomyopathy with or without obstruction
• Left ventricular ejection fraction (LVEF) ≤20%

Sponsors & Collaborators

• Emboline: lead

Study Sites (2)

NewYork-Presbyterian/Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

Oklahoma Heart Institute

Tulsa, Oklahoma, 74104, United States

RECRUITING

MeSH Terms

Conditions

Embolism

Interventions

Embolic Protection Devices

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Laura A Brenton

  Emboline, Inc.

  STUDY DIRECTOR

Central Study Contacts

Laura A Brenton

CONTACT

+1 313 919 8044; lbrenton@emboline.com

Duda Markovic

CONTACT

+1 858 220 2777; dmarkovic@emboline.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: G4: Model Description\* Subjects will be randomized (1:1) to either the Emboliner (ARM 1) or Sentinel CPS (ARM 2). Device randomization will be stratified by (a) site and (b) TAVR device type (Edwards or Medtronic) to ensure that each study arm represents an equivalent patient population.

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: January 13, 2023
• Study Start: May 4, 2023
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 19, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)