CAP-TEER: CerebrAl Protection During Transcatheter Edge-to-edge Repair
NCT ID: NCT06814210
Last Updated: 2025-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
120 participants
INTERVENTIONAL
2025-03-01
2025-10-31
Brief Summary
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This prospective, multi-center, randomized, controlled study aims to assess the efficacy and safety of cerebral protection device, compared to a control group undergoing unprotected M-TEER.
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Detailed Description
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Enrolled subjects will undergo a diffusion weighted magnetic resonance imaging (DW-MRI) at baseline and at 72 hours, to evaluate any new cerebral lesions. Enrolled subjects will be followed for 30 days.
The study aims to address:
* To determine whether the total amounts of new brain lesion assessed by diffusion weighted magnetic resonance images at 72 hours is comparable between the experimental group and the control group.
* To assess the effectiveness and safety of cerebral protection device in the prevention of perioperative cerebrovascular events after M-TEER
* To explore the correlation between the volume/number/location of new brain lesions and changes in neurocognitive function
* To evaluate the histopathological features of the captured fragments and their relevance to clinical features
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Cerebral Embolic Protection
Subjects will undergo M-TEER following placement of the cerebral embolic protection device.
Cerebral Embolic Protection
Subjects will undergo M-TEER following placement of the cerebral embolic protection device.
Control Arm
Subjects will undergo M-TEER without cerebral embolic protection device.
No interventions assigned to this group
Interventions
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Cerebral Embolic Protection
Subjects will undergo M-TEER following placement of the cerebral embolic protection device.
Eligibility Criteria
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Inclusion Criteria
* Age ≥18 years
* Severe Mitral Regurgitation (3+ to 4+)
* Symptom status: NYHA functional class ≥ II
* Subjects scheduled to receive the M-TEER per the current approved indications for use
* Subjects agreed to join the study and complete follow-up
Exclusion Criteria
* Contraindication to MRI
* CABG, PCI, TAVR, CRT or CRT-D within the prior 30 days
* Aortic or tricuspid valve disease requiring surgery or transcatheter intervention
* COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use
* Cerebrovascular accident within prior 30 days
* Severe symptomatic carotid stenosis (\>70% by ultrasound)
* Carotid surgery or stenting within prior 30 days
* Hemodynamic instability requiring inotropic support or mechanical heart assistance
* Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.
* Contraindication for transesophageal echocardiography
* Life expectancy \< 1 year
* Pregnant or planning pregnancy within next 12 months
* Participation in another interventional Trial
* Patients who are not able to give consent or complete the follow-up
18 Years
ALL
No
Sponsors
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Xiao-dong Zhuang
OTHER
Responsible Party
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Xiao-dong Zhuang
Dr.
Locations
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The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CAP-TEER
Identifier Type: -
Identifier Source: org_study_id
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