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Valvular Heart DiseaseNCT04618718

The PROTEMBO C Trial

A study testing cerebral embolic protection during TAVR in people with Valvular Heart Disease, run by Protembis GmbH at 8 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The PROTEMBO C Trial is an international, multi-center, single arm, non-inferiority study of the safety and performance of using the ProtEmbo System for cerebral embolic protection in subjects with severe native aortic valve stenosis indicated for TAVR. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Valvular Heart Disease
What is being tested?
cerebral embolic protection during TAVR
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
8 sitesin 3 countries
Study dates
31 Jul 2020to 23 Nov 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 valve aortic valve replace consistent with the 2017 ESC/EACTS Guidelines for the management of valvular heart disease.
  • Compatible left subclavian artery (≥ 4 mm diameter) without significant stenosis (> 70%) and distance between the origin of left subclavian artery and valve plain of ≥ 90mm as determined by Multi-Slice Computed Tomography (MSCT) scan or equivalent imaging modality.
  • 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:
  • Left upper limb vasculature in the left extremity precluding 6Fr sheath radial / brachial / subclavian access.
  • Inadequate circulation to the left extremity as evidenced by signs of artery occlusion (modified Allen's test) or absence of radial/brachial pulse.
  • Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity vasculature.
  • TAVR conducted via other than transfemoral access (subclavian, axillar, transapical, transaortic, carotid or transcaval).
  • Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment.
Show all 51Show fewer
  • Aortic valve is a congenital unicuspid or bicuspid valve.
  • Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+).
  • Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease).
  • Blood dyscrasias as defined: Leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy.
  • Hemodynamic instability requiring inotropic support or mechanical heart assistance.
  • Need for emergency surgery for any reason.
  • Severe hypertrophic cardiomyopathy with or without obstruction.
  • Severe ventricular dysfunction with LVEF ≤30%.
  • Echocardiographic evidence of intracardiac or aortic mass, thrombus, or vegetation.
  • Symptomatic or asymptomatic severe (≥ 70%) occlusive carotid disease requiring concomitant CEA / stenting.
  • Subject has undergone carotid stenting or carotid endarterectomy within the previous 6 weeks.
  • Active peptic ulcer or upper GI bleeding within the prior 6 months.
  • A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, or clopidogrel, device component material, or sensitivity to contrast media, which cannot be adequately premedicated.
  • Recent (within 6 months) CVA or a TIA.
  • Renal insufficiency (creatinine > 3.0 mg / dL or GFR < 30) and / or renal replacement therapy at the time of screening.
  • Life expectancy < 12 months due to non-cardiac co-morbid conditions.
  • Subjects in whom anti-platelet and / or anticoagulant therapy is contraindicated, or who will refuse transfusion.
  • Subjects who have active bacterial endocarditis or other active infections.
  • Currently participating in an investigational drug or another device study.
  • Subjects who have a planned treatment with any other investigational device or procedure during the study follow-up period (30 days).
  • Subjects with planned concomitant surgical or transcatheter ablation for Atrial Fibrillation during the study follow-up period (30 days).
  • Any subject with a balloon valvuloplasty (BAV) within 30 days of the procedure.
  • Subject is a woman of child-bearing potential.
  • Patient with Heparin-Induced Thrombocytopenia Syndrome.
  • Inner diameter of aortic arch is less than 25mm.
  • Brachiocephalic trunk originating from the aortic arch that splits into the bilateral subclavian arteries and a bicarotid trunk (Origin D).
  • Hepatic failure (defined as liver enzyme elevations two times the upper limit of normal) or active infectious hepatitis
  • Cardiogenic shock or severe hypotension (systolic blood pressure < 90 mm Hg) at the time of the index procedure
  • Subjects who have a planned concomitant cardiac surgical or interventional procedure (e.g., coronary revascularization) during the TAVI procedure
  • Subjects who have a pre-existing prosthetic heart valve in any position
  • Neurological:
  • 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.
  • Angiographic:
  • Excessive tortuosity or severe peripheral arterial disease in the left radial / brachial / subclavian artery preventing ProtEmbo System access and insertion.
  • Subject whose left radial / brachial / subclavian artery reveals significant stenosis, calcification, ectasia, dissection, occlusion or aneurysm, in particular at or within 3 cm of the aortic ostium.
  • Subject with significant stenosis, ectasia, dissection, or aneurysm in the ascending aorta or in the aortic arch, or with abnormal aortic arch angulation or abnormal anatomical conditions of the aorta.
  • Magnetic Resonance Imaging:
  • Subject 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).
  • Subjects who have a high risk of complete AV block after TAVR, with the need of permanent pacemaker (e.g. subjects with preexisting 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 4 days after TAVR.
  • Claustrophobia precluding MRI scanning.
  • No scanner hardware, software, coil or protocol changes during the course of the study.

Trial locations and contacts

8 sites in 3 countries.

8 sites in 3 countries

Germany4 sites

  • Universitätsklinikum Schleswig-Holstein

    Kiel, Schleswig-Holstein, 24105

  • Herzzentrum Leipzig-Universitätsklinik für Kardiologie-Helios

    Leipzig, Saxony, 04289

  • Universitätsklinikum Schleswig-Holstein (UKSH)

    Lübeck, Schleswig-Holstein, 23538

  • Krankenhaus der Barmherzigen Brüder Trier

    Trier, Rhineland-Palatinate, 54292

Other trials in Germany

Poland3 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

  • Szpital Kliniczny Przemienienia Panskiego Poznan University of Medical Sciences

    Poznan, 61-848

  • Department of Interventional Cardiology Warsaw Institute of Cardiology

    Warsaw

Other trials in Poland

Latvia1 site

  • Pauls Stradins Clinical University Hospital

    Riga

Other trials in Latvia

About this study

Official title: Cerebral Protection in Transcatheter Aortic Valve Replacement - The PROTEMBO C Trial

The PROTEMBO C Trial is an international, multi-center, single arm, non-inferiority study of the safety and performance of using the ProtEmbo System for cerebral embolic protection in subjects with severe native aortic valve stenosis indicated for TAVR.

Being tested
cerebral embolic protection during TAVR
Keywords
TAVR, cerebral embolic protection
Medical subject headings
Heart Valve Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cerebral embolic protection during TAVRDevice

    The ProtEmbo system is an adjunctive device placed in the central arterial system at the beginning of a TAVR procedure to deflect embolic particles during the procedure and removed following the completion of the procedure.

Study groups in NCT04618718
Study groupRoleWhat they receive
InterventionExperimentalProtEmbo device will be used as distal protection device in subjects undergoing TAVR
Receives: Device: cerebral embolic protection during TAVR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Participants With MACCE Events

    Number of participants experiencing a Major Adverse Cardiac and Cerebrovascular Event (MACCE) defined by VARC-2 including all-cause mortality, all stroke, life-threatening or disabling bleeding, vascular injury and acute kidney injury (stage 2 or 3) within 30 days of the procedure

    Measured: 30 days post-procedure

  2. Rate of Participants in Whom Technical Success Was Achieved

    Number of participants in whom technical success was achieved during the procedure. Technical success is defined as the ability to safely deliver, deploy, and remove the device, ability to secure positioning and stability of the position throughout the transcatheter intracardiac procedure and ability to deflect embolic material as assessed by adequate coverage while not impeding blood flow, deployed and removed and positioning and stability of the device

    Measured: During the procedure

Secondary outcomes (2)

  1. Efficacy-MR Imaging: Comparison Between the Median New Lesion Volume in the Brain

    Comparison between the median new lesion volume in the brain assessed by diffusion weighted magnetic resonance images (DW-MRI) at 2-7 days and historical data; the total new lesion volume is defined as the sum of all diffusion-positive new cerebral lesions in post-procedural DW-MRI relative to the pre-TAVR DW-MRI

    Measured: 2-7 days post-procedure

  2. Composite Rate of Death or All Strokes

    Death or all stroke according to VARC-2 criteria (to define occurrence and type stroke) within 3 days (72 hours) of the TAVR procedure compared to historical data

    Measured: 3 days post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2020
  2. Study start31 Jul 2020
  3. Primary completion23 Nov 2022
  4. Study completion23 Nov 2022

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04618718
Sponsor's protocol ID
CIP_00105
Status last verified
Apr 2025
First submitted
20 Oct 2020
Last updated
8 May 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fezzi S, Jagielak D, Targonski R, Schmidt T, Frerker C, Witkowski AR, Lauterbach M, Leick J, Erglis A, Narbute I, Grygier M, Misterski M, Frank D, Abdel-Wahab M, Wilde J, Adam M, Gatto F, Zivadinov R, Dwyer M, Werner N, Mylotte D. Final report of the PROTEMBO C Trial: a prospective evaluation of a novel cerebral protection device during TAVI. EuroIntervention. 2024 Feb 19;20(4):e264-e267. doi: 10.4244/EIJ-D-23-00743. No abstract available.

    PubMed 38389472

  • Jagielak D, Targonski R, Frerker C, Abdel-Wahab M, Wilde J, Werner N, Lauterbach M, Leick J, Grygier M, Misterski M, Erglis A, Narbute I, Witkowski AR, Adam M, Frank D, Gatto F, Schmidt T, Lansky AJ. Safety and performance of a novel cerebral embolic protection device for transcatheter aortic valve implantation: the PROTEMBO C Trial. EuroIntervention. 2022 Sep 20;18(7):590-597. doi: 10.4244/EIJ-D-22-00238.

    PubMed 35608032

Questions about this trial

What is this clinical trial studying?

A study testing cerebral embolic protection during TAVR in people with Valvular Heart Disease, run by Protembis GmbH at 8 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 5 inclusion and 51 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 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Germany, Poland, Latvia. 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?

Yes. Results are posted in the registry (first posted 8 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Rate of Participants With MACCE Events (time frame: 30 days 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?

On the ClinicalTrials.gov record for NCT04618718, which also lists 2 linked publications.

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 8 May 2025.

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