NCT06814210

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 7, 2025

Completed
22 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

February 7, 2025

Status Verified

February 1, 2025

Enrollment Period

7 months

First QC Date

January 19, 2025

Last Update Submit

February 5, 2025

Conditions

Mitral RegurgitationFunctional Mitral RegurgitationDegenerative Mitral Valve Regurgitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Total new lesion volume

    72 hours

  • Incidence of delirium

    7 days

  • NIHSS worsening

    30 days

  • Incidence of peri- and postprocedural stroke

    30 days

  • Incidences of MACCE at 30 days

    30 days and 1 year

Study Arms (2)

Cerebral Embolic Protection

EXPERIMENTAL

Subjects will undergo M-TEER following placement of the cerebral embolic protection device.

Device: Cerebral Embolic Protection

Control Arm

NO INTERVENTION

Subjects will undergo M-TEER without cerebral embolic protection device.

Interventions

Cerebral Embolic ProtectionDEVICE

Subjects will undergo M-TEER following placement of the cerebral embolic protection device.

Cerebral Embolic Protection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must meet ALL of the following 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

You may not qualify if:

  • Potential Subjects will be excluded if ANY of the following criteria apply:
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Central Study Contacts

Xiao-dong Zhuang MD

CONTACT

+8613760755035zhuangxd3@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

January 19, 2025

First Posted

February 7, 2025

Study Start

March 1, 2025

Primary Completion

September 30, 2025

Study Completion

October 31, 2025

Last Updated

February 7, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)