Severe Aortic Valve StenosisNCT05873816
The PROTEMBO Trial
A study testing ProtEmbo - Cerebral Embolic Protection and Sentinel - Cerebral Embolic Protection in people with Severe Aortic Valve Stenosis, run by Protembis GmbH at 20 sites in 3 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Aortic Valve Stenosis
- What is being tested?
- ProtEmbo - Cerebral Embolic Protection and Sentinel - Cerebral Embolic Protection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 20 sitesin 3 countries
- Study dates
- 21 Mar 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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%.
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- 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:
- Body Mass Index (BMI) precluding imaging in scanner.
- 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).
- 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).
- Planned implantation of a pacemaker or defibrillator implantation within the first 3 days after TAVR.
- Claustrophobia precluding MRI scanning.
- Anatomical and CT exclusion criteria:
- Excessive tortuosity in left subclavian artery (≥ 70° single kink or ≥ 50° in sequential kinks).
- Excessive tortuosity in right vascular access vessels for Sentinel introduction.
- 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.
- Left subclavian artery diameter is ≤ 4 mm.
- Brachiocephalic artery at the site of Sentinel filter placement < 9 mm or > 15 mm.
- Left common artery at the site of Sentinel filter placement < 6.5 mm or > 10 mm.
- Symptomatic or asymptomatic severe (≥ 70%) occlusive carotid disease requiring concomitant CEA / stenting.
- Inner diameter of aortic arch < 25 mm as measured in any position between ascending aorta and ostium of left subclavian artery.
- Distance between the origin of left subclavian artery and valve plain of < 90 mm.
- Common ostium of cerebral vessels, where all three vessels originate from one single ostium in the aortic arch.
- Significant stenosis, ectasia, dissection, aneurysm, or atheroma (mobile or > 5 mm thick) in the ascending aorta or in the aortic arch.
- 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).
- Distance between the origin of brachiocephalic trunk and left subclavian artery of > 65 mm.
Trial locations and contacts
20 sites in 3 countries.
20 sites in 3 countries
United States15 sites
University of Michigan
Ann Arbor, Michigan, 48109
State University of New York at Buffalo
Buffalo, New York, 14203
University of Virginia, Charlottesville
Charlottesville, Virginia, 22908
BayCare Health System / Morton Plant Hospital
Clearwater, Florida, 33756
University of Texas, Memorial Hermann Hospital
Houston, Texas, 77030
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Morristown Medical Center
Morristown, New Jersey, 07690
NYU Langone
New York, New York, 10016
Mount Sinai Hospital
New York, New York, 10029
Columbia University Medical Center / NYPH
New York, New York, 10032
Weill Medical College / Cornell University
New York, New York, 10065
Washington University - St. Louis
St Louis, Missouri, 63110
Tucson Medical Center Health
Tucson, Arizona, 85712
Germany4 sites
Dresden Herzzentrum
Dresden, 01307
Lübeck Universitätsklinikum Schleswig-Holstein Campus
Lübeck, 23562
Trier Krankenhaus der Barmherzigen Brüder
Trier, 54292
Ulm Universitätsklinikum
Ulm, 89081
About this study
Official title: Cerebral Protection in Transcatheter Aortic Valve Replacement: The PROTEMBO Trial
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.
Read the detailed description
Subjects with severe symptomatic aortic stenosis undergoing TAVR will be able to participate. Participants will be randomized in a 2:1:1 fashion to either the ProtEmbo arm, the Sentinel arm, or the 'No device' arm.
Enrolled subjects will undergo an MRI at baseline and at 36 hours ±12 hours, to evaluate any new cerebral lesions. Enrolled subjects will be followed for 30 days.
The study aims to address:
- whether the occurrence of all Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 days is comparable between the ProtEmbo group and the hybrid control group.
- whether the total new lesion volume in the brain assessed by diffusion weighted magnetic resonance images at 36 ±12 hours is comparable between the ProtEmbo group and the hybrid control group.
- Conditions
- Severe Aortic Valve Stenosis
- Being tested
- ProtEmbo - Cerebral Embolic Protection, Sentinel - Cerebral Embolic Protection
- Keywords
- TAVR, Cerebral embolic protection
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProtEmbo - Cerebral Embolic ProtectionDevice
Subjects will undergo TAVR following placement of the ProtEmbo cerebral embolic protection device.
Sentinel - Cerebral Embolic ProtectionDevice
Subjects will undergo TAVR following placement of the Sentinel cerebral embolic protection device.
| Study group | Role | What they receive |
|---|---|---|
| ProtEmbo - Cerebral Embolic Protection | Experimental | Subjects will undergo TAVR following placement of the ProtEmbo cerebral embolic protection device. Receives: Device: ProtEmbo - Cerebral Embolic Protection |
| Sentinel - Cerebral Embolic Protection | Active comparator | Subjects will undergo TAVR following placement of the Sentinel cerebral embolic protection device. Receives: Device: Sentinel - Cerebral Embolic Protection |
| Control Arm | No intervention | Subjects will undergo TAVR without embolic protection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACCE at 30 days
Occurrence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 days defined as all-cause mortality, all stroke, life-threatening or disabling bleeding, major vascular complications, and acute kidney injury (stage 2 or 3) as defined by VARC-3.
Measured: Up to Day 30 post procedure
Total new lesion volume
Total new lesion volume (TNLV) in the brain assessed by diffusion weighted magnetic resonance imaging (DW-MRI) at 36 ±12 hours.
Measured: 36 ±12 hours post TAVR procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start21 Mar 2024
- Primary completion18 Oct 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Protembis GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roxana Mehran, MD, Study chair, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05873816
- Sponsor's protocol ID
- CIP_00250
- Status last verified
- Jan 2026
- First submitted
- 15 May 2023
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Protection in Transcatheter Aortic Valve Replacement: The PROTEMBO Trial
- ClinicalTrials.gov ID
- NCT05873816
- Acronym / sponsor ID
- CIP_00250
- Conditions
- Severe Aortic Valve Stenosis
- Keywords
- TAVR, Cerebral embolic protection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Protembis GmbHIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2024 (actual)
- Primary completion
- 18 Oct 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Subjects with severe symptomatic aortic stenosis undergoing TAVR will be able to participate. Participants will be randomized in a 2:1:1 fashion to either the ProtEmbo arm, the Sentinel arm, or the 'No device' arm.
Enrolled subjects will undergo an MRI at baseline and at 36 hours ±12 hours, to evaluate any new cerebral lesions. Enrolled subjects will be followed for 30 days.
The study aims to address:
- whether the occurrence of all Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 days is comparable between the ProtEmbo group and the hybrid control group.
- whether the total new lesion volume in the brain assessed by diffusion weighted magnetic resonance images at 36 ±12 hours is comparable between the ProtEmbo group and the hybrid control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ProtEmbo - Cerebral Embolic Protection | Experimental | Device: ProtEmbo - Cerebral Embolic ProtectionSubjects will undergo TAVR following placement of the ProtEmbo cerebral embolic protection device. |
| Sentinel - Cerebral Embolic Protection | Active comparator | Device: Sentinel - Cerebral Embolic ProtectionSubjects will undergo TAVR following placement of the Sentinel cerebral embolic protection device. |
| Control Arm | No intervention | –Subjects will undergo TAVR without embolic protection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (44 listed)
- 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%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProtEmbo - Cerebral Embolic ProtectionSubjects will undergo TAVR following placement of the ProtEmbo cerebral embolic protection device. | Device | ProtEmbo - Cerebral Embolic Protection |
| Sentinel - Cerebral Embolic ProtectionSubjects will undergo TAVR following placement of the Sentinel cerebral embolic protection device. | Device | Sentinel - Cerebral Embolic Protection |
Primary outcome
MACCE at 30 days
Time frame: Up to Day 30 post procedure
Occurrence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 days defined as all-cause mortality, all stroke, life-threatening or disabling bleeding, major vascular complications, and acute kidney injury (stage 2 or 3) as defined by VARC-3.
Total new lesion volume
Time frame: 36 ±12 hours post TAVR procedure
Total new lesion volume (TNLV) in the brain assessed by diffusion weighted magnetic resonance imaging (DW-MRI) at 36 ±12 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roxana Mehran, MD study chair
Icahn School of Medicine at Mount Sinai
20 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ProtEmbo - Cerebral Embolic Protection and Sentinel - Cerebral Embolic Protection in people with Severe Aortic Valve Stenosis, run by Protembis GmbH at 20 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Germany, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACCE at 30 days (time frame: Up to Day 30 post procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.