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

NCT07055919 | Recruiting

• 2 other identifiers: QX2025-001-02Beijing Jiekai Cardiovascular
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Mitral R; Mitral Regurgitation

Outcome Measures

Primary Outcomes (1)

• Surgical Success Rate

  All of the following conditions need to be met 1. Successful implantation of 1 or more mitral clips (successful delivery and release of mitral clips with echocardiographic confirmation of leaflet clamping and successful withdrawal of the transcatheter mitral clip delivery system and manoeuvrable guide catheter); 2. Transthoracic echocardiography showing a degree of mitral regurgitation ≤2+ (as evaluated by a third-party core laboratory) prior to discharge (up to 7 days). Calculation formula: Surgical success rate (%) = (number of cases achieving surgical success in each group/total number of cases in each group) × 100% for each group

  7days

Secondary Outcomes (7)

• Instrumental technique success (trial group only)

  Perioperative/Periprocedural

• Clinical Success Rate

  7days

• Change in Mitral Regurgitation (MR) Severity

  7days/30days

• Change in NYHA Functional Class

  30days

• Mitral Clip Implantation Time

  Perioperative/Periprocedural

Study Arms (2)

Structural Heart Surgery Assist System-assisted TEER.

EXPERIMENTAL

Device: Structural Heart Surgery Assist System

Manual TEER (e.g., MitraClip G4).

PLACEBO COMPARATOR

Device: Manual MitraClip G4

Interventions

Structural Heart Surgery Assist System DEVICE

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 mitral valve repair. The procedure achieves regurgitation reduction by either creating a double-orifice configuration (A2/P2 segments) or approximating the opposing leaflets at the A1/P1 or A3/P3 regions.

Structural Heart Surgery Assist System-assisted TEER.

Manual MitraClip G4 DEVICE

Manual MitraClip G4

Manual TEER (e.g., MitraClip G4).

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiamen Cardiovascular Hospital, Xiamen University: lead

Study Sites (1)

Structural Heart Disease Unit, Xiamen Cardiovacular Hospital

Xiamen, Fujian, 361000, China

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Xiang Chen, Dr

CONTACT

18033997788; seanchenx@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: July 9, 2025
• Study Start: March 22, 2025
• Primary Completion: March 22, 2026
• Study Completion: April 22, 2026
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)