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The China Mviv Registry

NCT05925335 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-06-29

No results posted yet for this study

Summary

Mitral valve disease is the most common structure heart disease, and surgical valve replacement is an important treatment for severe mitral valve disease. There are 2 types of valve often been used, mechanical or biological protheses valves. Mechanical valve requires lifelong use of anticoagulants and take the risk of bleeding through all lifetime, but bioprotheses valve do not..

Conditions

  • Bioprosthesis Failure
  • Mitral Stenosis With Insufficiency
  • Mitral Stenosis
  • Mitral Regurgitation
  • Heart Failure

Interventions

DEVICE

Transseptal Transcatheter Mitral valve-in-valve Replacement

Transcatheter transfemoral mitral valve-in-valve replacement is an alternative surgery in patients with severe dysfunction of a degenerated mitral bioprosthesis and high surgical risk for repeat operation. The procedure is performed via femoral vein access. All procedures were carried out using intra-procedural TEE guidance to aid in transseptal puncture. After balloon septostomy, the bioprosthetic valve is introduced through the degenerative valve into the left ventricle and expanded in the mitral position during rapid ventricle pacing.

Sponsors & Collaborators

  • Xiamen Cardiovascular Hospital, Xiamen University

    lead OTHER

Principal Investigators

  • Yan Wang, Dr · Clinical Trial Center of Xiamen Cardiovascular Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-11
Primary Completion
2024-07-11
Completion
2025-06-11

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT05925335 on ClinicalTrials.gov