TEER for Severe DMR of Low to Intermediate Surgery Risk

NCT06162780 | Recruiting DMC FDA Device

• 1 other identifier: SYSKY-2023-1019-03
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

degenerative mitral regurgitation; transcatheter mitral valve edge-to-edge repair; surgery risk

Outcome Measures

Primary Outcomes (2)

• cumulative composite event rate of the main adverse events

  The main adverse events: death, acute myocardial infarction, requiring secondary therapy for valve treatment failure, requiring non-scheduled cardiovascular emergency surgery for main complications, stroke, kidney failure, deep infection, \>48 hours mechanical ventilation, new-onset atrial fibrillation, deep vein thrombosis, pulmonary embolism, sepsis, haemorrhage, blood transfusion \>2U

  time of operation to 30 days after operation

• cumulative composite event rate of all-cause death and worsening heart failure

  all-cause mortality: deaths from all causes including cardiovascular and non-cardiovascular deaths. worsening heart failure: heart failure rehospitalization, worsening heart failure needing emergency room visit, NYHA classification increased by one, ineffective escalation of medication on outpatient service, receiving intravenous diuretic therapy on outpatient or emergency service.

  time of operation to 24 months after operation

Study Arms (1)

TEER group

Severe DMR patients of low to intermediate surgery risk who underwent TEER.

Diagnostic Test: ultrasonic cardiography (UCG); Procedure: TEER

Interventions

ultrasonic cardiography (UCG) DIAGNOSTIC_TEST

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.

TEER group

TEER PROCEDURE

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.

TEER group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

severe DMR patients of low to intermediate surgery risk who underwent TEER.

You may qualify if:

• 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.

You may not qualify if:

• active infective endocarditis especially occurring in the mitral valve area, or mitral valve perforation.
• rheumatic mitral valve disease, mitral stenosis or mitral valve orifice area \< 4mm\^2.
• combined valve lesions requiring surgery, e.g. severe tricuspid regurgitation or aortic valve disease.
• the present of tumour, thrombus or redundant organisms in the heart chambers.
• inability to tolerate intraoperative or postoperative antithrombotic (anticoagulant or antiplate) therapy.
• acute DMR, e.g. DMR caused by acute papillary muscle rupture.
• Due to the presence of certain anatomical conditions, patient has a low success rate for TEER assessed by the operator and is not appropriate for enrolment. The conditions include but are not limited to the followings: 1) the venous approach is not suitable for operation, such as thrombus in the approach and small vein diameter; 2) severe calcification presents in the flap leaflet clamping area; 3) mitral valve cleft; 4) multiple regurgitant flow, especially in the internal and external union junction area; 5) Barlow disease; 6) leaflet length \<7mm; 7) flail gap \>10mm; 8) flail width \>15mm.
• severe cardiac insufficiency ( NYHA class IV or lefr ventricular ejection fraction (LVEF) \<20% ), end-stage heart failure status ( American College of Cardiology/American Heart Association (ACC/AHA) Stage D), relying on circulation aids or waiting for heart transplantation.
• proposed implantation of heart failure device such as cardiac resynchronization therapy/cardiac resynchronization therapy defibrillator (CRT/CRT-D) or cardiac contractility modulation (CCM).
• untreated severe coronary artery stenosis requiring coronary revascularization, or other cardiac macrovascular disease requiring surgery.
• hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or structural heart disease leading to heart failure other than dilated heart disease.
• severe pulmonary hypertension ( PASP \>70 mmHg), or pulmonary hypertension associated with no-left heart disease, e.g. pulmonary arterial hypertension (PAH) etc.
• acute myocardial infarction within 4 weeks before operation.
• acute cerebrovascular accident within 30 days before operation.
• acute peptic ulcer or upper gastrointestinal bleeding within 3 months before operation.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead
• Peking University Shenzhen Hospital: collaborator
• Dongguan People's Hospital: collaborator
• First People's Hospital of Foshan: collaborator
• The Second People's Hospital of Foshan: collaborator
• The First Affiliate Hospital of Guangxi Medical College: collaborator
• Affiliated Hospital of Guangdong Medical University: collaborator
• Huizhou Third People's Hospital: collaborator
• Jiangmen Central Hospital: collaborator
• Guangzhou Panyu Center Hospital: collaborator
• Meizhou People's Hospital: collaborator
• Suzhou Municipal Hospital: collaborator
• The General Hospital of Southern Theater Command: collaborator
• People's Hospital of Nanhai District, Foshan: collaborator
• Nanfang Hosptial, China: collaborator
• Southern Medical University, China: collaborator
• First Affiliated Hospital of Shantou University Medical College: collaborator
• Shantou Central Hospital: collaborator
• Sichuan Provincial People's Hospital: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• People's Hospital of Xinjiang Uygur Autonomous Region: collaborator
• Yueyang Central Hospital: collaborator
• ZhuZhou Central Hospital: collaborator
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• Third Affiliated Hospital, Sun Yat-Sen University: collaborator
• Fifth Affiliated Hospital, Sun Yat-Sen University: collaborator
• Central South University Xiangya Hospital: collaborator
• Zhongshan People's Hospital, Guangdong, China: collaborator
• Foshan Fosun Chancheng Hospital: collaborator

Study Sites (1)

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

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Yangxin Chen, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yangxin Chen, PhD

CONTACT

8681332360; chenyx39@mail.sysu.edu.cn

Maohuan Lin

CONTACT

8681332360; chenyx39@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 8, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

CN (1)