RECRUITING

Protect the Head to Head Study

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Protect the Head to Head: A Safety and Efficacy Assessment of the Emboliner Embolic Protection Device

Quick Facts

Study Start:2023-05-04

Study Completion:2024-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05684146

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Study Contact

Laura A Brenton

CONTACT

+1 313 919 8044

lbrenton@emboline.com

Duda Markovic

CONTACT

+1 858 220 2777

dmarkovic@emboline.com

Principal Investigator

Laura A Brenton

STUDY_DIRECTOR

Emboline, Inc.

Study Locations (Sites)

NewYork-Presbyterian/Columbia University Medical Center

New York, New York, 10032

United States

Oklahoma Heart Institute

Tulsa, Oklahoma, 74104

United States

Collaborators and Investigators

Sponsor: Emboline

Laura A Brenton, STUDY_DIRECTOR, Emboline, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-04

Study Completion Date2024-12

Study Record Updates

Study Start Date2023-05-04

Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

MACCE
TAVR
Embolism

Additional Relevant MeSH Terms

Embolism