TEER for Severe DMR of Low to Intermediate Surgery Risk

RecruitingOBSERVATIONAL
Enrollment

160

Participants

Timeline

Start Date

January 1, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Mitral Regurgitation
Interventions
DIAGNOSTIC_TEST

ultrasonic cardiography (UCG)

Trans-thoracic echocardiography (TTE) is performed in the resting position. Trans-esophageal echocardiography (TEE) is performed under surface anaesthesia with bupivacaine or intravenous anaesthesia. We comprehensively assess the severity of mitral regurgitation according to American Society of Echocardiography (ASE) guideline.

PROCEDURE

TEER

Two commercial cliping systems are available for clinical use: the G3 MitraclipTM and the G4 MitraclipTM (Abbott), DragonflyTM (Dejin), which will be introduced to the Chinese market in 2024, with the specific choice determined by the operator. The patient receives general anaesthesia (intravenous and endotracheal). The operator performs the procedure according to the recommended surgical steps in the product manual, guided by X-ray and trans-esophageal echocardiography. Postoperative MR ≤2+ is considered successful, and if the result is unsatisfactory, 1-2 additional clips are given.

Trial Locations (1)

510000

RECRUITING

Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou

All Listed Sponsors
collaborator

Peking University Shenzhen Hospital

OTHER

collaborator

Dongguan People's Hospital

OTHER_GOV

collaborator

First People's Hospital of Foshan

OTHER

collaborator

The Second People's Hospital of Foshan

OTHER

collaborator

The First Affiliate Hospital of Guangxi Medical College

UNKNOWN

collaborator

Affiliated Hospital of Guangdong Medical University

OTHER

collaborator

Huizhou Third People's Hospital

UNKNOWN

collaborator

Jiangmen Central Hospital

OTHER

collaborator

Guangzhou Panyu Center Hospital

UNKNOWN

collaborator

Meizhou People's Hospital

OTHER

collaborator

Suzhou Municipal Hospital

OTHER

collaborator

The General Hospital of Southern Theater Command

OTHER

collaborator

People's Hospital of Nanhai District, Foshan

UNKNOWN

collaborator

Nanfang Hosptial, China

UNKNOWN

collaborator

Southern Medical University, China

OTHER

collaborator

First Affiliated Hospital of Shantou University Medical College

OTHER

collaborator

Shantou Central Hospital

OTHER

collaborator

Sichuan Provincial People's Hospital

OTHER

collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

collaborator

People's Hospital of Xinjiang Uygur Autonomous Region

OTHER

collaborator

Yueyang Central Hospital

OTHER

collaborator

ZhuZhou Central Hospital

OTHER

collaborator

First Affiliated Hospital, Sun Yat-Sen University

OTHER

collaborator

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

collaborator

Fifth Affiliated Hospital, Sun Yat-Sen University

OTHER

collaborator

Central South University Xiangya Hospital

UNKNOWN

collaborator

Zhongshan People's Hospital, Guangdong, China

OTHER

collaborator

Foshan Fosun Chancheng Hospital

UNKNOWN

lead

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

NCT06162780 - TEER for Severe DMR of Low to Intermediate Surgery Risk | Biotech Hunter | Biotech Hunter