CAP-TEER: CerebrAl Protection During Transcatheter Edge-to-edge Repair

Xiao-dong Zhuang

Status

Not yet enrolling

Conditions

Degenerative Mitral Valve Regurgitation

Functional Mitral Regurgitation

Mitral Regurgitation

Treatments

Device: Cerebral Embolic Protection

Study type

Interventional

Funder types

Other

Identifiers

NCT06814210

CAP-TEER

Details and patient eligibility

About

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.

Full 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

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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