TEER for Severe DMR of Low to Intermediate Surgery Risk

Summary

To investigate the efficacy and safety of transcatheter mitral valve edge-to-edge repair (TEER) for severe degenerative mitral regurgitation (DMR) patients of low to intermediate surgery risk.

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.

Sponsors & Collaborators

• Peking University Shenzhen Hospital

  collaborator OTHER

• Dongguan People's Hospital

  collaborator OTHER_GOV

• First People's Hospital of Foshan

  collaborator OTHER

• The Second People's Hospital of Foshan

  collaborator OTHER

• The First Affiliate Hospital of Guangxi Medical College

  collaborator UNKNOWN

• Affiliated Hospital of Guangdong Medical University

  collaborator OTHER

• Huizhou Third People's Hospital

  collaborator UNKNOWN

• Jiangmen Central Hospital

  collaborator OTHER

• Guangzhou Panyu Center Hospital

  collaborator UNKNOWN

• Meizhou People's Hospital

  collaborator OTHER

• Suzhou Municipal Hospital

  collaborator OTHER

• The General Hospital of Southern Theater Command

  collaborator OTHER

• People's Hospital of Nanhai District, Foshan

  collaborator UNKNOWN

• Nanfang Hosptial, China

  collaborator UNKNOWN

• Southern Medical University, China

  collaborator OTHER

• First Affiliated Hospital of Shantou University Medical College

  collaborator OTHER

• Shantou Central Hospital

  collaborator OTHER

• Sichuan Provincial People's Hospital

  collaborator OTHER

• First Affiliated Hospital Xi'an Jiaotong University

  collaborator OTHER

• People's Hospital of Xinjiang Uygur Autonomous Region

  collaborator OTHER

• Yueyang Central Hospital

  collaborator OTHER

• ZhuZhou Central Hospital

  collaborator OTHER

• First Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Third Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Fifth Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Central South University Xiangya Hospital

  collaborator UNKNOWN

• Zhongshan People's Hospital, Guangdong, China

  collaborator OTHER

• Foshan Fosun Chancheng Hospital

  collaborator UNKNOWN

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

  lead OTHER

Principal Investigators

• Yangxin Chen, PhD · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-01

Primary Completion

2026-12-31

Completion

2026-12-31

FDA Device

Yes

Countries

• China

Study Locations