The PROTEMBO SF Trial

NCT03325283 | Completed

• 1 other identifier: CIP_00104, Rev 02, 23 May 2017
• Study Type: interventional
• Target: 5
• Locations: 2 countries
• Sites: 2

Brief Summary

The PROTEMBO SF Trial is a prospective, observational, multi-center, intention-to-treat study of the safety and feasibility of the ProtEmbo Cerebral Protection System in subjects with severe symptomatic native aortic valve stenosis indicated for TAVR.

Conditions

Aortic Stenosis

Keywords

stroke prevention; embolic protection; cognition

Outcome Measures

Primary Outcomes (6)

• Procedural success

  defined as successful access, delivery to, deployment within, and retrieval of the ProtEmbo System from the aortic arch as well as adequate coverage of side branch vessels and maintenance of position for duration of the TAVR procedure.

  1 day

• In-hospital procedural safety up to 7 days

  defined as occurrence of all Major Adverse Cardiac and Cerebrovascular Events (MACCEs) defined by the Valve Academic Research Consortium (VARC-2) criteria, including device-related safety outcomes (peri-procedural rates of TIA, all-cause mortality, all stroke (disabling and non-disabling), life-threatening (or disabling) bleeding, acute kidney injury (stage 2 or 3), major vascular complications and other device related complications).

  7 days

• Stroke severity

  quantified according to the National Institutes of Health Stroke Scale (NIHSS) score at day 3 (±2).

  3 days

• Stroke severity

  quantified according to the National Institutes of Health Stroke Scale (NIHSS) score at 30 days (±7).

  30 days

• Occurrence of Serious Adverse Events

  as defined by ISO 14155 up to 3 (±2) days or discharge (whichever is later) and 30 days (±7).

  3 days

• Occurrence of Serious Adverse Events

  as defined by ISO 14155 at 30 days (±7).

  30 days

Secondary Outcomes (7)

• Frequency of new cerebral lesions

  3 days

• Number of new cerebral lesions

  3 days

• Volume of new cerebral lesions

  3 days

• Frequency of new cerebral lesions

  30 days

• Number of new cerebral lesions

  30 days

Study Arms (1)

Protembo device treatment

EXPERIMENTAL

Patients who consent to participate in the PROTEMBO SF Trial and in whom the ProtEmbo Cerebral Protection System is used or is attempted to be used.

Device: ProtEmbo Cerebral Protection System

Interventions

ProtEmbo Cerebral Protection System DEVICE

A catheter-based embolic deflection device will be positioned in the arch of the aorta to prevent debris liberated during the TAVR procedure from entering the three major vessels of the aortic arch.

Protembo device treatment

Eligibility Criteria

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

You may qualify if:

• Approved indications for commercially available transcatheter aortic valves by transfemoral route. Refer to the selected valve IFU for additional details.
• Compatible left subclavian artery (≥ 4 mm diameter) without significant stenosis (\> 70%) and distance between the origin of left subclavian artery and valve plain is ≥ 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 has been informed of the nature of the trial, agrees to its provisions and has provided written informed consent as approved by the national or local regulatory authorities of the respective clinical site.
• Subject is a minimum of 18 years of age.

You may not qualify if:

• Left upper limb vasculature precluding 6Fr sheath (radial or brachial 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).
• Pre-existing prosthetic heart valve in any position, prosthetic ring, or severe (greater than 3+) mitral insufficiency.
• 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 (2)

Department of Cardiology Galway University Hospital and SAOLTA Healthcare Group

Galway, County Galway, H91HHTO, Ireland

Location

Pauls Stradins Clinical University Hospital

Riga, LV1002, Latvia

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• James C. Leiter, M.D.

  Avania

  STUDY DIRECTOR

Study Design

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

Model Details: Human patients indicated for transcatheter aortic valve replacement

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: October 30, 2017
• Study Start: August 9, 2017
• Primary Completion: August 31, 2018
• Study Completion: October 30, 2018
• Last Updated: October 31, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

LA (1); IE (1)