Severe Aortic Valve Stenosis
Conditions
Keywords
TAVR, Cerebral embolic protection
Brief 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 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.
Interventions
DEVICEProtEmbo - Cerebral Embolic Protection
Subjects will undergo TAVR following placement of the ProtEmbo cerebral embolic protection device.
DEVICESentinel - Cerebral Embolic Protection
Subjects will undergo TAVR following placement of the Sentinel cerebral embolic protection device.
Sponsors
Protembis GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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. 2. 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. 3. 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. 4. Subject is a minimum of 18 years of age.
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACCE at 30 days | 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 | 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. |
Countries
Germany, Poland, United States
Outcome results
None listed