Effect of RT3D-TEE-guided Mitral Valve Repair on Outcomes in Patients With Degenerative Mitral Valve Disease

NCT ID: NCT05595226

Last Updated: 2022-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

338 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-31

Study Completion Date

2026-12-31

Brief Summary

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The aim of this randomized controlled trial to investigate the effects of Real-time 3D transesophageal echocardiography (RT3D-TEE)-guided mitral valve repair on surgical failure and 1-year reoccurrence of mitral valve regurgitation in patients with degenerative mitral value disease.

Detailed Description

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Conditions

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Degenerative Mitral Valve Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RT3D-TEE-guided mitral valve repair

Two experienced surgeons and two experienced echocardiography technicians jointly formulated the plan for the TEE-guided mitral valve repair.

Group Type EXPERIMENTAL

RT3D-TEE-guided mitral valve repair

Intervention Type PROCEDURE

RT3D-TEE forms a surgical plan before surgery and 3 to 4 senior doctors with more than 50 cases of mitral valve repair perform the procedure.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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RT3D-TEE-guided mitral valve repair

RT3D-TEE forms a surgical plan before surgery and 3 to 4 senior doctors with more than 50 cases of mitral valve repair perform the procedure.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with chronic primary degenerative mitral regurgitation by the preoperative echocardiogram.
* Informed consent was obtained

Exclusion Criteria

* Re-operation of mitral regurgitation
* Concurrent surgical plan for congenital heart disease, coronary artery bypass grafting, aortic valve surgery, radiofrequency ablation of atrial fibrillation and other cardiac surgeries.
* Mitral valve replacement
* Unable to undergo TEE
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheng Liu

OTHER

Sponsor Role lead

Responsible Party

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Sheng Liu

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Fuwai Hospital,Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Sheng Liu, MD

Role: primary

86-13501331366

Other Identifiers

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TEE-MVR Project

Identifier Type: -

Identifier Source: org_study_id

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