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.
The PROTEMBO SF Trial is a prospective, single arm, 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
5
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.
Department of Cardiology Galway University Hospital and SAOLTA Healthcare Group
Galway, County Galway, Ireland
Pauls Stradins Clinical University Hospital
Riga, Latvia
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.
Time frame: 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).
Time frame: 7 days
Stroke severity
quantified according to the National Institutes of Health Stroke Scale (NIHSS) score at day 3 (±2).
Time frame: 3 days
Stroke severity
quantified according to the National Institutes of Health Stroke Scale (NIHSS) score at 30 days (±7).
Time frame: 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).
Time frame: 3 days
Occurrence of Serious Adverse Events
as defined by ISO 14155 at 30 days (±7).
Time frame: 30 days
Frequency of new cerebral lesions
defined by diffusion weighted magnetic resonance imaging (DW-MRI) prior to discharge at day 3 (±2) compared to baseline and/ or historical control group;
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 3 days
Number of new cerebral lesions
defined by diffusion weighted magnetic resonance imaging (DW-MRI) prior to discharge at day 3 (±2) compared to baseline and/ or historical control group;
Time frame: 3 days
Volume of new cerebral lesions
defined by diffusion weighted magnetic resonance imaging (DW-MRI) prior to discharge at day 3 (±2) compared to baseline and/ or historical control group;
Time frame: 3 days
Frequency of new cerebral lesions
defined by Diffusion weighted- and FLAIR-MRI sequence at 30 days (±7 days).
Time frame: 30 days
Number of new cerebral lesions
defined by Diffusion weighted- and FLAIR-MRI sequence at 30 days (±7 days).
Time frame: 30 days
Volume of new cerebral lesions
defined by Diffusion weighted- and FLAIR-MRI sequence at 30 days (±7 days).
Time frame: 30 days
Cognitive function
defined as change in neurocognitive testing at 30 (+/- 7) days post-procedure using MoCA post-procedure compared to baseline.
Time frame: 30 days