The PROTEMBO C Trial

NCT04618718 | Completed Results

• 1 other identifier: CIP_00105
• Study Type: interventional
• Target: 64
• Locations: 3 countries
• Sites: 8

Brief 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.

Conditions

Valvular Heart Disease

Keywords

TAVR; cerebral embolic protection

Outcome Measures

Primary Outcomes (2)

• 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

  30 days post-procedure

• 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

  During the procedure

Secondary Outcomes (2)

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

  2-7 days post-procedure

• Composite Rate of Death or All Strokes

  3 days post-procedure

Study Arms (1)

Intervention

EXPERIMENTAL

ProtEmbo device will be used as distal protection device in subjects undergoing TAVR

Device: cerebral embolic protection during TAVR

Interventions

cerebral embolic protection during TAVR DEVICE

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Protembis GmbH: lead
• Avania: collaborator

Study Sites (8)

Krankenhaus der Barmherzigen Brüder Trier

Trier, Rhineland-Palatinate, 54292, Germany

Location

Herzzentrum Leipzig-Universitätsklinik für Kardiologie-Helios

Leipzig, Saxony, 04289, Germany

Location

Universitätsklinikum Schleswig-Holstein

Kiel, Schleswig-Holstein, 24105, Germany

Location

Universitätsklinikum Schleswig-Holstein (UKSH)

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Pauls Stradins Clinical University Hospital

Riga, Latvia

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-214, Poland

Location

Szpital Kliniczny Przemienienia Panskiego Poznan University of Medical Sciences

Poznan, 61-848, Poland

Location

Department of Interventional Cardiology Warsaw Institute of Cardiology

Warsaw, Poland

Location

Related Publications (2)

• 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.

  PMID: 38389472 RESULT

• 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.

  PMID: 35608032 RESULT

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Karl von Mangoldt
• Organization: Protembis GmbH

kvm@protembis.com

+49 241 9903 3621

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: November 6, 2020
• Study Start: July 31, 2020
• Primary Completion: November 23, 2022
• Study Completion: November 23, 2022
• Last Updated: May 8, 2025
• Results First Posted: May 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4); LA (1); PL (3)