Protect the Head to Head Study

Status unconfirmed · Phase 2

Conditions studied: Embolism

In brief

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

Key facts

Study ID

NCT05684146

Run by

Emboline

People needed

540

Starts

2023-05-04

Expected to finish

2024-12-01

Last updated by the study team

2023-05-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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%
• 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

Where it is running

• NewYork-Presbyterian/Columbia University Medical Center — New York, New York, United States (enrolling)
• Oklahoma Heart Institute — Tulsa, Oklahoma, United States (enrolling)

Full record on ClinicalTrials.gov

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