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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Mitral Regurgitation; Functional Mitral Regurgitation; Degenerative Mitral Valve Regurgitation
• Intervention / Treatment: Device: Cerebral Embolic Protection

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

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiao-dong Zhuang MD; Phone Number: +8613760755035; Email: zhuangxd3@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • The First Affiliated Hospital of Sun Yat-Sen University
      • Contact: Xiao-dong Zhuang MD; Phone Number: +8613760755035; Email: zhuangxd3@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cerebral Embolic Protection; Subjects will undergo M-TEER following placement of the cerebral embolic protection device.	Device: Cerebral Embolic Protection; Subjects will undergo M-TEER following placement of the cerebral embolic protection device.
No Intervention: Control Arm; Subjects will undergo M-TEER without cerebral embolic protection device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total amounts of new lesions	Total amounts of new lesions in the brain assessed by diffusion weighted magnetic resonance imaging (DW-MRI) at 72 hours.	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total new lesion volume	Total new lesion volume assessed by diffusion weighted magnetic resonance imaging (DW-MRI) at 72 hours	72 hours
Incidence of delirium	Incidence of delirium	7 days
NIHSS worsening	NIHSS worsening	30 days
Incidence of peri- and postprocedural stroke	Incidence of peri- and postprocedural stroke	30 days
Incidences of MACCE at 30 days	The incidences of Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 days defined as all-cause mortality, all stroke, life-threatening or disabling bleeding, major vascular complications, and acute kidney injury (stage 2 or 3, including renal replacement therapy)	30 days and 1 year

Collaborators and Investigators

• Sponsor: Xiao-dong Zhuang

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: January 19, 2025
• First Submitted That Met QC Criteria: February 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: CAP-TEER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No