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

NCT06814210 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-02-07

No results posted yet for this study

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.

Conditions

  • Mitral Regurgitation
  • Functional Mitral Regurgitation
  • Degenerative Mitral Valve Regurgitation

Interventions

DEVICE

Cerebral Embolic Protection

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

Sponsors & Collaborators

  • Xiao-dong Zhuang

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2025-09-30
Completion
2025-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06814210 on ClinicalTrials.gov