Cerebral Protection in Transcatheter Aortic Valve Replacement

What is the Purpose of this Study?

The purpose of this study is to evaluate the safety and feasibility of an experimental filter system called the ProtEmbo Cerebral Protection System (ProtEmbo Device) in patients who are undergoing TAVR and have a risk of stoke within 30 days after TAVR. The device is designed to block and deflect debris (emboli) from the aortic valve that may be released during transcatheter aortic valve replacement (TAVR). Researchers want to determine whether using the ProtEmbo Cerebral Protection System helps to reduce brain injury from emboli released during the TAVR procedure. The System is a filter that covers the openings to the arteries that lead to the brain from the top of the aorta. Participants will undergo the standard-of-care TAVR procedure and will be randomly assigned to 1 of the 3 study groups. The ProtEmbo (investigational device group) and Sentinel (device group approved by the U.S. Food and Drug Administration) may help reduce brain injury from emboli released during the TAVR procedure.

Eligibility

1. 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.
2. 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.
3. 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.
4. Subject is a minimum of 18 years of age.

Inclusion Criteria:

1. 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.
2. 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.
3. 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.
4. Subject is a minimum of 18 years of age.

Exclusion Criteria:

1. Subject is a woman of child-bearing potential.
2. Arm anatomy/ vasculature precluding radial or brachial artery access.
3. Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity vasculature.
4. Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment.
5. Severe ventricular dysfunction with LVEF ≤25%.
6. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 10 days of the index procedure.
7. 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.
8. Hemodynamic instability, or pressure dependence requiring pharmacological inotropic support or mechanical heart assistance.
9. Echocardiographic evidence of intracardiac or aortic mass, thrombus not adequately treated, or vegetation.
10. Active peptic ulcer or upper GI bleeding within the prior 6 months.
11. Contraindication for anticoagulant or antiplatelet therapy.
12. Renal insufficiency (creatinine \> 3.0 mg / dL or GFR \< 30) and / or renal replacement therapy at the time of screening and dialysis patients.
13. Current or planned treatment with any investigational drug or investigational device during the study follow-up period (30 days).
14. Balloon aortic valvuloplasty (BAV) within 30 days of the procedure.
15. Cardiogenic shock, hemodynamic instability, or severe hypotension (systolic blood pressure \< 90 mm Hg) at the time of the index procedure.
16. Cardiovascular surgical or interventional procedure 10 days prior or planned during the TAVR procedure or during the 30-day study follow-up.
17. 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.
1. Cerebrovascular event including TIA within 6 months of the procedure.
2. Subject had active major psychiatric disease.
3. 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.
4. Subjects with neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.
1. Body Mass Index (BMI) precluding imaging in scanner.
2. Contraindications to MRI (subjects with any implantable temporary or permanent pacemaker or defibrillator, metal implants in field of view, metallic fragments, clips, or devices in the brain or eye before TAVR procedure).
3. High risk of complete AV block after TAVR, with the need of permanent pacemaker (e.g., subjects with pre-existing bifascicular block or complete right bundle branch block plus any degree of AV block).
4. Planned implantation of a pacemaker or defibrillator implantation within the first 3 days after TAVR.
5. Claustrophobia precluding MRI scanning.
1. Excessive tortuosity in left subclavian artery (≥ 70° single kink or ≥ 50° in sequential kinks).
2. Excessive tortuosity in right vascular access vessels for Sentinel introduction.
3. Significant stenosis (≥ 70%), calcification, ectasia, dissection, occlusion, aneurysm, or severe peripheral arterial disease in left or right arm access vessels - in particular at or within 3 cm of the aortic ostia.
4. Left subclavian artery diameter is ≤ 4 mm.
5. Brachiocephalic artery at the site of Sentinel filter placement \< 9 mm or \> 15 mm.
6. Left common artery at the site of Sentinel filter placement \< 6.5 mm or \> 10 mm.
7. Symptomatic or asymptomatic severe (≥ 70%) occlusive carotid disease requiring concomitant CEA / stenting.
8. Inner diameter of aortic arch \< 25 mm as measured in any position between ascending aorta and ostium of left subclavian artery.
9. Distance between the origin of left subclavian artery and valve plain of \< 90 mm.
10. Common ostium of cerebral vessels, where all three vessels originate from one single ostium in the aortic arch.
11. Significant stenosis, ectasia, dissection, aneurysm, or atheroma (mobile or \> 5 mm thick) in the ascending aorta or in the aortic arch.
12. Significant angulation of the proximal segment of the left subclavian or aortic arch angulation or abnormal anatomical conditions of the aorta (a Type 3 aortic arch is not a reason for exclusion).
13. Distance between the origin of brachiocephalic trunk and left subclavian artery of \> 65 mm.

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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

Cerebral Protection in Transcatheter Aortic Valve Replacement: The PROTEMBO Trial

Study Details

Disease Type/Condition

Other

Principal Investigator

Makkar, Rajendra

Age Group

Adult

Phase

II/III

IRB Number

STUDY00002717

ClinicalTrials.gov ID

NCT05873816

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org