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RECRUITING
NCT06162780

TEER for Severe DMR of Low to Intermediate Surgery Risk

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

View on ClinicalTrials.gov

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.

Official title: The Efficacy and Safety of TEER for Severe DMR Patients of Low to Intermediate Surgery Risk (TESLA-R)--a Multi-center, Prospective Cohort Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

160

Start Date

2024-01-01

Completion Date

2026-12

Last Updated

2024-03-15

Healthy Volunteers

No

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.

Locations (1)

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

Guangzhou, Guangdong, China