The objective of this study is to demonstrate that use of the Sentinel® Cerebral Protection System significantly reduces the risk of periproceduralstroke (*72 hours) after transcatheter aortic valve replacement (TAVR).
ID
Source
Brief title
PROTECTED TAVR
Condition
- Other condition
- Cardiac valve disorders
- Vascular therapeutic procedures
Synonym
Health condition
Neurological
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is all stroke (hemorrhagic, ischemic, or undetermined
status; disabling or nondisabling) through 72 hours
post TAVR procedure or discharge (whichever comes first), as adjudicated by an
independent Clinical Events Committee (CEC)
and using Neurologic Academic Research Consortium (NeuroARCa) definitions.
Secondary outcome
Not applicable
Background summary
Based on observations in the SENTINEL trial, the United States Food and Drug
Administration (FDA) in June 2017 approved the Sentinel® Cerebral Protection
System for use in TAVR as a cerebral protection device to capture and remove
embolic material while performing transcatheter aortic valve procedures in
order to reduce ischemic injury to the brain peri-procedurally. However, while
results from the SENTINEL trial provided reassuring evidence of the safety of
dual-filter neuroprotection therapy and confirmed the high frequency of embolic
debris capture, the effectiveness of the Sentinel CEPD at reducing stroke risk
after TAVR remains uncertain.
Although Sentinel was approved by FDA for capturing debris during TAVR, the
pivotal RCT missed its primary endpoint. In the same trial, post hoc analysis
showed clinical benefit with reduction in procedural stroke. However,
prospective data to prove clinical benefit are lacking. The objective of the
PROTECTED TAVR study is to demonstrate that use of Sentinel significantly
reduces the risk of peri-procedural stroke (*72 hours) after TAVR.
Study objective
The objective of this study is to demonstrate that use of the Sentinel®
Cerebral Protection System significantly reduces the risk of periprocedural
stroke (*72 hours) after transcatheter aortic valve replacement (TAVR).
Study design
PROTECTED TAVR is a prospective, post-market, multicenter, randomized
controlled trial (RCT) evaluating use of the Sentinel Cerebral Protection
System in subjects with aortic valve stenosis who are treated with a
commercially available TAVR device.
Intervention
Participants who meet the study criteria will be randomly assigned in a 1:1
ratio to receive either the medical device or not during Transcatheter
Aortic Valve Replacement.
Study burden and risks
Risks associated with TAVR and use of the commercial Sentinel Cerebral
Protection System are listed in the IFU and in the ICF. There are no
incremental risks associated with participation in this clinical study.
Additional risks may exist. Risks can be minimized through compliance with this
protocol, performing procedures in the appropriate hospital environment,
adherence to subject selection criteria, close monitoring of the subject's
physiologic status during research procedures and/or follow-ups and by promptly
supplying BSC with all pertinent information required by this protocol.
Data will be monitored as they are submitted to BSC. Qualified employees of
BSC, or a designee under contract, will conduct monitoring visits at the
initiation of the study and at interim intervals described in the monitoring
plan throughout the course of the study to evaluate protocol compliance and
determine if there are any issues that could affect the safety or welfare of
any subject in the study.
It is expected that the commercially available Sentinel Cerebral Protection
System may provide benefit to the subject by capturing potentially harmful
embolic debris liberated during the TAVR procedure. Without such protection,
embolic debris could travel unimpeded via the cerebral circulation to the
brain; this could lead to cerebral vascular events such as stroke and/or TIA.
Boston Scientific Way 300
Marlborough MA 0175201234
US
Boston Scientific Way 300
Marlborough MA 0175201234
US
Listed location countries
Age
Inclusion criteria
All eligible subjects should be approached for participation in the trial.
Subjects who meet all of the following criteria will be evaluated for
enrollment in this trial, provided no exclusion criterion
(below) is met.
IC1. Subject has documented aortic valve stenosis and is treated with an
approved TAVR device via transfemoral access.
IC2. Subject has the recommended artery diameter at the site of filter
placement per the Sentinel® Cerebral Protection System Instructions For Use: 9*
15 mm for the brachiocephalic artery and
6.5*10 mm in the left common carotid artery.
IC3. Subject (or legal representative) provides written informed consent.
Exclusion criteria
Subjects who meet any one of the following criteria (listed as
contraindications in the Sentinel® Cerebral Protection System IFU) will be
excluded from this clinical trial.
EC1. Subject has arterial stenosis >70% in either the left common carotid
artery or the brachiocephalic artery.
EC2. Subject*s brachiocephalic or left carotid artery reveals significant
stenosis, ectasia, dissection, or aneurysm at the aortic ostium or within 3 cm
of the aortic ostium.
EC3. Subject has compromised blood flow to the right upper extremity.
EC4. Subject has access vessels with excessive tortuosity.
EC5. Subject has uncorrected bleeding disorders.
EC6. Subject is contraindicated for anticoagulant and antiplatelet
therapy.
Note 4: Use of general anesthesia during TAVR may affect neurocognitive
function shortly after the procedure. While not an exclusion criterion, it is
recommended that general anesthesia not be
used if possible.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04149535 |
| CCMO | NL72827.078.20 |