MRI Investigation in Transcatheter Aortic Valve replacement with Claret: a randomized study to assess by MRI the reduction in cerebral embolic lesions during Transcatheter Aortic Valve Replacement with the Claret embolic protection device

MRI Investigation in Transcatheter Aortic Valve replacement with Claret: a randomized study to assess by MRI the reduction in cerebral embolic lesions during Transcatheter Aortic Valve Replacement with the Claret embolic protection device - MISTRAL-C

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39581

Enrollment

Registered

2012-10-26

Start date

2013-01-09

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cerebral embolism stroke

Interventions

A 6F radial artery sheath is introduced using the Seldinger Technique. The Claret device is advanced through a right radial access deploying the distal basket in the left common carotid artery and t

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) Patients with severe AS at high operative risk who will undergo planned TAVI 2) Informed consent to participate in the study (i.e. use of Claret device yes or no) and undergo DW -MRI before and after the procedure. 3) Compatible left common carotid artery (>= 5 mm) and brachiocephalic artery (>= 9 mm) diameters without significant stenosis (> 70%) as determined by Multi-Slice Computed Tomography (MSCT) scan

Exclusion criteria

Exclusion criteria: 1) No written informed consent 2) Standard exclusion criteria for MRI study (see Appendix 4) 3) Anatomical exclusion for filter deployment 4) Permanent Pacemaker/AICD in situ before TAVI 5) Planned implantation of a pacemaker implantation after TAVI. 6) Previous stroke with residual neurological symptoms or dementia 7) Not native Dutch speaking

Design outcomes

Primary

Measure	Time frame
Primary endpoint - Incidence, number and volume of new cerebral ischemic lesions as detected by DW -MRI post TAVI.	—

Secondary

Measure	Time frame
Secondary endpoints • 30-day Neurology endpoint: any new transient or persisting focal neurological deficit as determined by an experienced neurologist excluding the time the patient is under influence of anesthetics. • Changes in Neurocognitive function at 3 months follow up • 30 day mortality • Device related bleeding and vascular complications. • Histlogic examination of debris captured by the Claret Device	—

Measure

Time frame

Secondary endpoints • 30-day Neurology endpoint: any new transient or persisting focal neurological deficit as determined by an experienced neurologist excluding the time the patient is under influence of anesthetics. • Changes in Neurocognitive function at 3 months follow up • 30 day mortality • Device related bleeding and vascular complications. • Histlogic examination of debris captured by the Claret Device

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)