Structural Heart Surgery Assist System for Transcatheter Mitral Valve Edge-to-Edge Repair (TEER).

Official title

A Prospective, Multicenter, Stratified Randomized Controlled, Non-Inferiority Clinical Trial to Evaluate the Safety and Efficacy of the Structural Heart Surgery Assist System for Transcatheter Mitral Valve Edge-to-Edge Repair (TEER).

Overview

This trial aims to evaluate the safety and efficacy of the Structural Heart Surgery Assist System in assisting TEER for patients with moderate-to-severe or greater degenerative or functional mitral regurgitation (MR ≥3+). A prospective, multicenter, stratified randomized controlled design with non-inferiority comparison will be used. The experimental group will utilize the Structural Heart Surgery Assist System, while the control group will undergo manual TEER (e.g., MitraClip G4).

Interventions

• Device Structural Heart Surgery Assist System
  Following femoral venous access and transseptal puncture, the steerable guide catheter and transcatheter mitral valve clip system are inserted and mounted onto the Structural Heart Surgery Assist System. The surgeon manipulates the joystick and controls on the operator console, guided by real-time animations on the human-machine interface that confirm the direction and range of device motion. Under fluoroscopic (DSA) and echocardiographic guidance, the system assists in performing edge-to-edge m
• Device Manual MitraClip G4
  Manual MitraClip G4

Primary outcome measures

• Surgical Success Rate [Time frame: 7days]

Secondary outcome measures (7)

• Instrumental technique success (trial group only) [Time frame: Perioperative/Periprocedural]
• Clinical Success Rate [Time frame: 7days]
• Change in Mitral Regurgitation (MR) Severity [Time frame: 7days/30days]
• Change in NYHA Functional Class [Time frame: 30days]
• Mitral Clip Implantation Time [Time frame: Perioperative/Periprocedural]
• Fluoroscopy Time [Time frame: Perioperative/Periprocedural]
• Operator Radiation Exposure [Time frame: Perioperative/Periprocedural]

Eligibility criteria

Inclusion criteria

• Age ≥18 years, regardless of gender.
• Symptomatic moderate-to-severe or greater mitral regurgitation (MR ≥3+) confirmed by transthoracic and/or transesophageal echocardiography (TTE/TEE), with planned transcatheter edge-to-edge repair (TEER):

For degenerative mitral regurgitation (DMR):

-Deemed high-risk for surgical intervention by the heart team:STS score ≥8% for mitral valve replacement (MVR) mortality risk; ≥6% for mitral valve repair mortality risk; OR presence of ≥2 frailty indices (moderate-to-severe frailty); OR anatomical/technical barriers to surgery; OR ≥2 major organ dysfunctions unlikely to improve postoperatively; OR other high-risk factors per heart team assessment.OR patient declines surgery.

For functional mitral regurgitation (FMR):

• Persistent heart failure symptoms (NYHA Class III/IVa) despite guidelines directed medical therapy (GDMT), revascularization, or cardiac resynchronization therapy (CRT) for 1-3 months.
• ≥1 hospitalization for heart failure within the past 12 months and/or BNP >150 pg/mL or NT-proBNP >600 pg/mL.
• Left ventricular ejection fraction (LVEF) ≥20% and ≤50%, with left ventricular end-systolic diameter (LVESD) ≤70 mm.
• Primary regurgitant jet is non-commissural and deemed treatable by the investigator (secondary jets, if present, must be clinically insignificant).
• Volunteerly provides informed consent, understands the trial objectives, and agrees to comply with follow-up.

Exclusion criteria

• Rheumatic mitral valve disease.
• Uncorrected active infection.
• Severe calcification or thickening in the clip coaptation zone, rendering TEER anatomically unsuitable.
• Intracardiac mass, thrombus, or vegetation on echocardiography.
• Severe right heart dysfunction (e.g., lower extremity edema with elevated jugular venous pressure and hepatomegaly) or severe pulmonary hypertension (echocardiographic systolic pulmonary artery pressure >70 mmHg).
• Severe left heart dysfunction (LVEF <20%).
• Acute myocardial infarction (AMI) within 30 days prior to the procedure.
• Recent CABG, PCI, or TAVR within 30 days prior to the procedure.
• Planned tricuspid/aortic valve or major vascular intervention within 30 days post-procedure.
• Prior surgical or transcatheter mitral valve repair/replacement.
• Thrombosis in access vessels (e.g., femoral vein, inferior vena cava) impeding catheter advancement.
• Stroke/TIA within 30 days or severe carotid stenosis (>70% by ultrasound).
• Cardiomyopathies or conditions including hypertrophic, restrictive, or infiltrative cardiomyopathy (e.g., amyloidosis, hemochromatosis, sarcoidosis), constrictive pericarditis, or active endocarditis.
• Hemodynamic instability: Systolic blood pressure <90 mmHg without afterload-reducing agents, cardiogenic shock, requirement for intra-aortic balloon pump (IABP) or hemodynamic support.
• Implanted pacemaker, CRT, or ICD within 30 days prior to the procedure.
• End-stage heart failure (ACC/AHA Stage D), post-heart transplant, or listed for transplant.
• Hypersensitivity or contraindications: ntolerance to anticoagulants, antiplatelet agents, or anesthesia, allergy to mitralclip materials (nickel/titanium, cobalt, chromium, polyester), severe contrast allergy precludes intervention.
• Pregnant or breastfeeding.
• Participation in other clinical trials (drug/device) without meeting primary endpoints.
• Other contraindications per investigator judgment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Structural Heart Disease Unit, Xiamen Cardiovacular Hospital — Xiamen

Identifiers

NCT: NCT07055919 · QX2025-001-02 · Beijing Jiekai Cardiovascular

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗