ProtectH2H: Protect the Head to Head Study

• Sponsor: Emboline (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05684146
• Collaborator: (none)
• Enrollment: 540
• Arms: 2
• Anticipated Duration (Months): 14

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Embolism	Device: Emboliner Embolic Protection; Device: Sentinel Cerebral Protection	Phase 2

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 540 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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)
• Primary Purpose: Treatment
• Official Title: Protect the Head to Head: A Safety and Efficacy Assessment of the Emboliner Embolic Protection Device
• Anticipated Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Mar 1, 2024
• Anticipated Study Completion Date: May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Emboliner Embolic Protection Device Emboliner embolic protection device to be used during TAVR procedures for stroke prevention	Device: Emboliner Embolic Protection; Emboliner Embolic Protection Device will be used to capture and remove embolic material during transcatheter aortic valve replacement (TAVR) interventions; Other Names: Embolic protection
Active Comparator: Sentinel Cerebral Protection System Sentinel Cerebral Protection System to be used during TAVR procedures for stroke prevention	Device: Sentinel Cerebral Protection; The Sentinel Cerebral Protection System will be used to capture and remove embolic material during transcatheter aortic valve replacement (TAVR) interventions; Other Names: Embolic protection

Outcome Measures

Primary Outcome Measures

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

   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

1. Non-inferiority VARC-2 [30 Days]

   Non-inferiority of 30-day Emboliner device VARC 2-defined stroke incidence rate compared to the Sentinel device incidence rate.

2. Debris Capture [30 Days]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Eligible for treatment for symptomatic severe aortic stenosis using a FDA-approved TAVR valve according to current guidelines

2. Consented to the TAVR procedure

3. Subject and physician agree that subject will return for required post-procedure follow-up

4. Willing to participate in study and provide signed EC/IRB-approved informed consent

5. Eighteen (18) years or older at the time of consent

Exclusion Criteria:

1. Not undergoing a planned TAVR via transfemoral access

2. Severe allergy or hypersensitivity to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, nitinol, and/or contrast agents that cannot be pre-medicated

3. Uncorrected bleeding disorder

4. Hypercoagulation status that cannot be corrected by additional peri-procedural heparin

5. Myocardial infarction (MI) diagnosis <30 days prior to study procedure

6. History of substance abuse that may cause non-compliance with the protocol or confound the data interpretation

7. Cardiogenic shock, hemodynamic instability requiring inotropic support or mechanical heart assistance, or severe hypotension (systolic blood pressure <90 mmHg) at time of screening

8. History of a stroke < 180 days prior to study procedure

9. Active peptic ulcer or history of upper gastrointestinal (GI) bleeding < 90 days prior to study procedure

10. Congenital unicuspid aortic valve

11. Porcelain aorta, asymmetrical or sharp aortic calcifications, severe aortic tortuosity, shaggy aorta or mobile atheroma in the arch

12. Pre-existing prosthetic heart valve in any position, prosthetic ring, or severe (greater than 3+) mitral insufficiency

13. Current leukopenia, acute anemia, thrombocytopenia, history of chronic bleeding diathesis, or coagulopathy that requires treatment

14. Hypertrophic cardiomyopathy with or without obstruction

15. Left ventricular ejection fraction (LVEF) ≤20%

16. Echocardiographic evidence of intracardiac or aortic mass, thrombus, or vegetation

17. Active infection or endocarditis

18. Neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic defaults

19. Carotid stent placement or endarterectomy performed <180 days prior to study procedure.

20. Severe renal insufficiency (creatinine >3.0 mg/dL or GFR <30 mL/min) or patient on dialysis

21. Planned treatment with another investigational device or procedure during the study period

22. Balloon valvuloplasty (BAV) within 30 days of the procedure

23. 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

24. Emergency surgery for any reason

25. Pregnancy, lactation or intent to become pregnant during study participation

26. 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

27. Investigator considers participation in the study not to be in the subject's best interest

28. Dementia or any other cognitive deficit that results in inability to provide informed consent or comply with the study protocol

29. Presence of hemodialysis shunt, graft, or arterio-venous fistula involving access vasculature

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Emboline

Investigators

• Study Director: Laura A Brenton, Emboline, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Emboline
• ClinicalTrials.gov Identifier: NCT05684146
• Other Study ID Numbers: TP-0527
• First Posted: Jan 13, 2023
• Last Update Posted: Jan 13, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Emboline: MACCE; TAVR; Embolism
• Additional relevant MeSH terms: Embolism

Study Results

No Results Posted as of Jan 13, 2023