Feasibility Study of the transShield Embolic Protection System
Reason given: Study Sponsor closing study due to financial circumstances.
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Trial details
- Who runs it
- TransAortic Medical, Inc.
- Trial code
- NCT06652841
- Record updated
- 14 August 2025
- Original description
The objective of this study is to evaluate the initial safety and performance of the transShield EPS used for embolic protection during Transcatheter Aortic Valve Replacement (TAVR).Read full original descriptionShow less
Prospective, Multi-center, Single Arm Feasibility Study of the transShield Embolic Protection System
The objective of this study is to evaluate the initial safety and performance of the transShield EPS used for embolic protection during Transcatheter Aortic Valve Replacement (TAVR).
Inclusion: Patient is ≥18 years old; Patient is scheduled for percutaneous TAVR using a commercial TAVR system; Patient meets indications for TAVR per the device IFU; The diameter of the artery at the site of the filter placement is ≤ 42 mm; Size and condition of the femoral artery iliac arteries are appropriate for the 10F transShield Introducer; Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study mandated procedures; Patient is willing and able to complete follow-up requirement.
Exclusion: History of stroke or transient ischemic attack (TIA) within prior 6 months; Evidence of an acute myocardial infarction (MI) within 30 days prior to study procedure; Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within prior 30 days; Planned other cardiac surgical procedure within 2 weeks prior to or planned cardiac surgical or interventional procedure within 30 days after the TAVR procedure; Note: Diagnostic cardiac catheterization is permitted within 10 days prior to the TAVR procedure; Currently enrolled in an investigational drug or device clinical study in which the primary endpoint has not occurred; A known contraindication or hypersensitivity to all anticoagulation regimens or an inability to undergo anticoagulation for the study procedure; Renal disease requiring chronic dialysis at time of treatment; Severe pulmonary hypertension and right ventricular (RV) dysfunction; Life expectancy <12 months due to non-cardiac co-morbid conditions; Evidence of active systemic or local groin infection; Significant aortic disease, including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5cm or greater; marked tortuosity (hyperacute bend), aortic arch atheroma or severe atheroma (especially with calcification and surface irregularities) of the thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta; Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, ticlopidine, or clopidogrel, and/or contrast agents, that cannot be managed with premedication; Known allergy to any device component; History of bleeding diathesis or in whom anticoagulant and/or anti- platelet therapy is contraindicated, patients who will refuse transfusion, or have an active peptic ulcer or upper GI bleeding within the prior 3 months; Severe left ventricular (LV) dysfunction with LV ejection fraction (LVEF) <20%; Patient not undergoing TAVR via the trans-femoral route; Carotid artery stenosis > 70% in either carotid artery; Severe vascular tortuosity or anatomy that would preclude the safe introduction of the device; Aortic valve is a congenital unicuspid valve or is non-calcified; Predominant aortic regurgitation >3+; Echocardiographic evidence of intracardiac mass, thrombus or vegetation; Known or suspected to be pregnant or lactating; Patient has other medical, social or psychological problem that in the opinion of the investigator precludes them from participating.