CAP-TEER: CerebrAl Protection During Transcatheter Edge-to-edge Repair
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cerebral Embolic Protection.
- Who it may be relevant to
- Registry conditions: Mitral Regurgitation, Functional Mitral Regurgitation, Degenerative Mitral Valve Regurgitation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Transcatheter edge-to-edge repair of the mitral valve (M-TEER) is a well-established endovascular treatment option for patients with severe mitral regurgitation who are at high risk for surgery-related complications. However, the procedure carries a risk of clinically overt strokes and imaging-detected brain lesions, which may potentially be mitigated through the use of cerebral protection devices. 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.
Detailed description
Subjects with indications for M-TEER and who meet study eligibility criteria will be randomized 1:1 to one of two treatment arms: 1) intervention: cerebral protection device with M-TEER or 2) Control: Unprotected M-TEER.
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
Interventions
- Device Cerebral Embolic Protection
Subjects will undergo M-TEER following placement of the cerebral embolic protection device.
Primary outcome measures
- Total amounts of new lesions [Time frame: 72 hours]
Secondary outcome measures (5)
- Total new lesion volume [Time frame: 72 hours]
- Incidence of delirium [Time frame: 7 days]
- NIHSS worsening [Time frame: 30 days]
- Incidence of peri- and postprocedural stroke [Time frame: 30 days]
- Incidences of MACCE at 30 days [Time frame: 30 days and 1 year]
Eligibility criteria
Inclusion criteria
Subjects must meet ALL of the following criteria:
General 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
Potential Subjects will be excluded if ANY of the following criteria apply:
General 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- The First Affiliated Hospital of Sun Yat-sen University — Guangzhou
Identifiers
NCT: NCT06814210 · CAP-TEER