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
Location: See location...
Intervention Type: Procedure, Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• age ≥ 18 years old

• DMR ≥ grade 3+ according to UCG integrative approach, referring to the following quantitative indicators: 1) effective regurgitant orifice area (EROA) ≥0.3cm\^2; 2) regurgitant volume (RVol) ≥45ml; 3) regurgitant fraction (RF) ≥40%.

• symptomatic heart failure ( New York Heart Association (NYHA) class II-IV ), or asymptomatic heart failure with left ventricular end systolic dimension (LVESd) ≥40mm or ejection fraction (EF) ≤60%, or new-onset atrial fibrillation, or resting pulmonary artery systolic pressure (PASP) \>50mmHg.

• The patient with American Association of Thoracic Surgeons Score (STS) \<8 has surgical indications evaluated by cardiac team.

• The patient has signed an informed consent form and agreed to regular follow-up for at least 1 year.

Locations
Other Locations
China
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
Yangxin Chen, PhD
chenyx39@mail.sysu.edu.cn
8681332360
Backup
Maohuan Lin
chenyx39@mail.sysu.edu.cn
8681332360
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 160
Treatments
TEER group
Severe DMR patients of low to intermediate surgery risk who underwent TEER.
Related Therapeutic Areas
Sponsors
Collaborators: People's Hospital of Xinjiang Uygur Autonomous Region, ZhuZhou Central Hospital, Jiangmen Central Hospital, The First Affiliate Hospital of Guangxi Medical College, Third Affiliated Hospital, Sun Yat-Sen University, Meizhou People's Hospital, People's Hospital of Nanhai District, Foshan, The General Hospital of Southern Theater Command, Peking University Shenzhen Hospital, Nanfang Hosptial, China, Dongguan People's Hospital, Affiliated Hospital of Guangdong Medical University, First Affiliated Hospital of Shantou University Medical College, Huizhou Third People's Hospital, Sichuan Provincial People's Hospital, Southern Medical University, China, First Affiliated Hospital Xi'an Jiaotong University, Shantou Central Hospital, Fifth Affiliated Hospital, Sun Yat-Sen University, First People's Hospital of Foshan, Central South University Xiangya Hospital, First Affiliated Hospital, Sun Yat-Sen University, Suzhou Municipal Hospital, Guangzhou Panyu Center Hospital, The Second People's Hospital of Foshan, Yueyang Central Hospital, Zhongshan People's Hospital, Guangdong, China, Foshan Fosun Chancheng Hospital
Leads: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

This content was sourced from clinicaltrials.gov