Clinical trial NCT06814210: CAP-TEER: CerebrAl Protection During Transcatheter Edge-to-edge Repair
Official title: CAP-TEER: CerebrAl Protection During Transcatheter Edge-to-edge Repair
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mitral Regurgitation
Functional Mitral Regurgitation
Degenerative Mitral Valve Regurgitation
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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

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

Primary outcomes:
measure: Total amounts of new lesions
timeFrame: 72 hours
Secondary outcomes:
measure: Total new lesion volume
timeFrame: 72 hours
measure: Incidence of delirium
timeFrame: 7 days
measure: NIHSS worsening
timeFrame: 30 days
measure: Incidence of peri- and postprocedural stroke
timeFrame: 30 days
measure: Incidences of MACCE at 30 days
timeFrame: 30 days and 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References: