The PROTEMBO Trial

Completed · Not applicable

Conditions studied: Severe Aortic Valve Stenosis

In brief

The goal of this prospective, multi-center, randomized, controlled study is to compare the safety and efficacy of the ProtEmbo Cerebral Embolic Protection device to a hybrid control (no embolic protection device ('No Device') and the Sentinel device) in subjects with severe symptomatic native aortic valve stenosis indicated undergoing a TAVR procedure.

Key facts

Study ID

NCT05873816

Run by

Protembis GmbH

People needed

284

Starts

2024-03-21

Expected to finish

2025-12-31

Last updated by the study team

2026-01-09

Who can join

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

You may qualify if…

• The heart team recommends transcatheter aortic valve replacement via femoral access consistent with the 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease.
• The subject and the treating physician agree that the subject will undergo the scheduled pre procedural testing and return for all required post procedure follow up visits.
• The subject is able to provide informed consent, has been informed of the nature of the trial, agrees to its provisions and has provided written informed consent as approved by the relevant regulatory authority of the respective clinical site.
• Subject is a minimum of 18 years of age.

You may not qualify if…

• General exclusion criteria:
• Subject is a woman of child-bearing potential.
• Arm anatomy/ vasculature precluding radial or brachial artery access.
• Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity vasculature.
• Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment.
• Severe ventricular dysfunction with LVEF ≤25%.
• Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 10 days of the index procedure.
• Blood dyscrasias as defined by clinically significant leukopenia (< 500 leukocytes / μL), acute anemia (Hgb < 8 g / dL), thrombocytopenia (< 80,000 platelets / μl), history of bleeding diathesis or coagulopathy.
• Hemodynamic instability, or pressure dependence requiring pharmacological inotropic support or mechanical heart assistance.
• Echocardiographic evidence of intracardiac or aortic mass, thrombus not adequately treated, or vegetation.
• Active peptic ulcer or upper GI bleeding within the prior 6 months.
• Contraindication for anticoagulant or antiplatelet therapy.
• Renal insufficiency (creatinine > 3.0 mg / dL or GFR < 30) and / or renal replacement therapy at the time of screening and dialysis patients.
• Current or planned treatment with any investigational drug or investigational device during the study follow-up period (30 days).
• Balloon aortic valvuloplasty (BAV) within 30 days of the procedure.
• Cardiogenic shock, hemodynamic instability, or severe hypotension (systolic blood pressure < 90 mm Hg) at the time of the index procedure.
• Cardiovascular surgical or interventional procedure 10 days prior or planned during the TAVR procedure or during the 30-day study follow-up.
• Patients with severe chronic obstructive pulmonary disease (COPD)
• NOTE: Use of general anesthesia during TAVR may affect neurocognitive function shortly after the procedure. While not an exclusion criterion, it is recommended that general anesthesia not be used if possible.
• Neurological exclusion criteria:
• Cerebrovascular event including TIA within 6 months of the procedure.
• Subject had active major psychiatric disease.
• Subject has severe visual, auditory, or learning impairment and is unable to comprehend English or local language and therefore unable to be consented for the study.
• Subjects with neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.
• Magnetic resonance imaging exclusion criteria:

Where it is running

• Tucson Medical Center Health — Tucson, Arizona, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• BayCare Health System / Morton Plant Hospital — Clearwater, Florida, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Saint Luke&#39;s Hospital of Kansas City — Kansas City, Missouri, United States
• Washington University - St. Louis — St Louis, Missouri, United States
• Morristown Medical Center — Morristown, New Jersey, United States
• State University of New York at Buffalo — Buffalo, New York, United States
• NYU Langone — New York, New York, United States
• Mount Sinai Hospital — New York, New York, United States
• Columbia University Medical Center / NYPH — New York, New York, United States
• Weill Medical College / Cornell University — New York, New York, United States
• University of Texas, Memorial Hermann Hospital — Houston, Texas, United States
• University of Virginia, Charlottesville — Charlottesville, Virginia, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Dresden Herzzentrum — Dresden, Germany
• Lübeck Universitätsklinikum Schleswig-Holstein Campus — Lübeck, Germany
• Trier Krankenhaus der Barmherzigen Brüder — Trier, Germany
• Ulm Universitätsklinikum — Ulm, Germany
• Gdansk Uniwersyteckie Centrum Kliniczne — Gdansk, Poland

Full record on ClinicalTrials.gov

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