NCT06162780

TEER for Severe DMR of Low to Intermediate Surgery Risk

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 160 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a proposed multicentre, prospective cohort study to enrol and follow up severe DMR patients of low to intermediate surgery risk who underwent TEER, and surgical historical controls. The primary efficacy endpoints are all-cause death and cumulative composite event rate of worsening heart failure at 24 months postoperatively, and the primary safety endpoints are death, secondary surgery, and various complications at 30 days postoperatively. The study aims to investigate the efficacy and safety of TEER in surgical low-intermediate-risk patients with severe DMR, and to inform the subsequent clinical application.

Conditions

• Mitral Regurgitation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2023-12-08
• Last updated: 2024-03-15

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study