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Protect the Head to Head Study (ProtectH2H)

Primary Purpose

Embolism

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Emboliner Embolic Protection
Sentinel Cerebral Protection
Sponsored by
Emboline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Embolism focused on measuring MACCE, TAVR, Embolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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% Echocardiographic evidence of intracardiac or aortic mass, thrombus, or vegetation Active infection or endocarditis Neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic defaults Carotid stent placement or endarterectomy performed <180 days prior to study procedure. Severe renal insufficiency (creatinine >3.0 mg/dL or GFR <30 mL/min) or patient on dialysis Planned treatment with another investigational device or procedure during the study period Balloon valvuloplasty (BAV) within 30 days of the procedure Any planned surgical or interventional cardiac procedure (e.g., concurrent coronary revascularization or AF ablation) during the TAVR procedure, within 30 days before or after the TAVR procedure Emergency surgery for any reason Pregnancy, lactation or intent to become pregnant during study participation Unable or unwilling to complete all required screening and/or follow-up assessments, including subjects with active major psychiatric disease; with severe visual, auditory, or learning impairment Investigator considers participation in the study not to be in the subject's best interest Dementia or any other cognitive deficit that results in inability to provide informed consent or comply with the study protocol Presence of hemodialysis shunt, graft, or arterio-venous fistula involving access vasculature

Sites / Locations

  • NewYork-Presbyterian/Columbia University Medical CenterRecruiting
  • Oklahoma Heart InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Emboliner Embolic Protection Device

Sentinel Cerebral Protection System

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Non-inferiority VARC-2
Non-inferiority of 30-day Emboliner device VARC 2-defined stroke incidence rate compared to the Sentinel device incidence rate.
Debris Capture
The count (by number of particles >150 microns) of debris capture using the Emboliner device will be compared to the count of debris captured by the Sentinel device.

Full Information

First Posted
January 5, 2023
Last Updated
May 17, 2023
Sponsor
Emboline
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1. Study Identification

Unique Protocol Identification Number
NCT05684146
Brief Title
Protect the Head to Head Study
Acronym
ProtectH2H
Official Title
Protect the Head to Head: A Safety and Efficacy Assessment of the Emboliner Embolic Protection Device
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 4, 2023 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Emboline

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Prospective, randomized, open label, multicenter, 2-arm, safety and efficacy study
Detailed Description
Prospective, randomized, open label, multicenter, 2-arm, safety and efficacy study to demonstrate safety and effectiveness based on non-inferiority of the study device (Emboliner EPD) compared to the control device (Sentinel CPS) in terms of a 30-day composite major adverse cardiac and cerebrovascular events (MACCE) rate - defined as all death, stroke and Stage 3 acute kidney injury - evaluated on a per-patient basis, post-TAVR procedures

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Embolism
Keywords
MACCE, TAVR, Embolism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
540 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Emboliner Embolic Protection Device
Arm Type
Experimental
Arm Description
Emboliner embolic protection device to be used during TAVR procedures for stroke prevention
Arm Title
Sentinel Cerebral Protection System
Arm Type
Active Comparator
Arm Description
Sentinel Cerebral Protection System to be used during TAVR procedures for stroke prevention
Intervention Type
Device
Intervention Name(s)
Emboliner Embolic Protection
Other Intervention Name(s)
Embolic protection
Intervention Description
Emboliner Embolic Protection Device will be used to capture and remove embolic material during transcatheter aortic valve replacement (TAVR) interventions
Intervention Type
Device
Intervention Name(s)
Sentinel Cerebral Protection
Other Intervention Name(s)
Embolic protection
Intervention Description
The Sentinel Cerebral Protection System will be used to capture and remove embolic material during transcatheter aortic valve replacement (TAVR) interventions
Primary Outcome Measure Information:
Title
Non-inferiority
Description
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
Time Frame
Non-inferiority of 30-day Emboliner device MACCE patient incidence rate compared to the Sentinel device patient incidence rate.
Secondary Outcome Measure Information:
Title
Non-inferiority VARC-2
Description
Non-inferiority of 30-day Emboliner device VARC 2-defined stroke incidence rate compared to the Sentinel device incidence rate.
Time Frame
30 Days
Title
Debris Capture
Description
The count (by number of particles >150 microns) of debris capture using the Emboliner device will be compared to the count of debris captured by the Sentinel device.
Time Frame
30 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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% Echocardiographic evidence of intracardiac or aortic mass, thrombus, or vegetation Active infection or endocarditis Neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic defaults Carotid stent placement or endarterectomy performed <180 days prior to study procedure. Severe renal insufficiency (creatinine >3.0 mg/dL or GFR <30 mL/min) or patient on dialysis Planned treatment with another investigational device or procedure during the study period Balloon valvuloplasty (BAV) within 30 days of the procedure Any planned surgical or interventional cardiac procedure (e.g., concurrent coronary revascularization or AF ablation) during the TAVR procedure, within 30 days before or after the TAVR procedure Emergency surgery for any reason Pregnancy, lactation or intent to become pregnant during study participation Unable or unwilling to complete all required screening and/or follow-up assessments, including subjects with active major psychiatric disease; with severe visual, auditory, or learning impairment Investigator considers participation in the study not to be in the subject's best interest Dementia or any other cognitive deficit that results in inability to provide informed consent or comply with the study protocol Presence of hemodialysis shunt, graft, or arterio-venous fistula involving access vasculature
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura A Brenton
Phone
+1 313 919 8044
Email
lbrenton@emboline.com
First Name & Middle Initial & Last Name or Official Title & Degree
Duda Markovic
Phone
+1 858 220 2777
Email
dmarkovic@emboline.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura A Brenton
Organizational Affiliation
Emboline, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
NewYork-Presbyterian/Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
Oklahoma Heart Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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