NCT07414225

Safety and Efficacy of Transcatheter Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation

Safety and Efficacy of Transcatheter Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation - The STAR Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Beijing Anzhen Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, randomized, parallel-control, open-label, multicenter clinical trial. Eligible subjects will be randomized in a 1:1 ratio to the Device group (Interventional group) or to no Device group (Control Group). The objective is to identify the safety and effectiveness of the TEER for the treatment of moderate-to-severe (3+) or severe (4+) atrial functional mitral regurgitation (aFMR) in patients who are symptomatic despite maximally tolerated guideline directed medical therapy.

Detailed description

Atrial functional mitral regurgitation (AFMR) is a complex cardiovascular condition typified by mitral regurgitation (MR), primarily due to atrial fibrillation-induced or diastolic dysfunction-induced left atrial enlargement, with mitral annular dilation and functional alterations of the mitral valve, rather than intrinsic valvular defects, resulting in regurgitation1. The reported prevalence of AFMR varies across studies, attributable to discrepancies in definitions, diagnostic techniques, research designs, and the specific populations investigated2-8. In a cohort study of hospitalized patients undergoing atrial fibrillation ablation, the prevalence of moderate or severe AFMR was 7%1. Conversely, in a community-based screening cohort of patients with moderate or severe MR, AFMR accounted for 27% of cases, marginally lower than the proportions of ventricular functional mitral regurgitation (VFMR, 38%) and primary mitral regurgitation (PMR, 32%)9. It can be anticipated that with the acceleration of aging in the global population, the proportion of AFMR may witness a considerable expansion in the future. Compared with PMR, patients with AFMR frequently present with greater symptoms, diminished exercise tolerance, and heightened risk for hospitalization due to heart failure and increased mortality9,10, underscoring AFMR as a challenging therapeutic scenario. The conventional management strategies for mitral regurgitation have proven less effective in cases of AFMR2,11,12, due to its unique pathophysiological mechanisms, highlighting the imperative for customized treatment modalities. Optimized guideline-directed medical therapy (GDMT) has been the cornerstone of treatment for heart failure and associated valvular diseases, including AFMR13. GDMT for heart failure with reduced LVEF typically includes a combination of a beta-blockers, ACE inhibitor, angiotensin receptor blockers or ARNI, a mineralocorticoid receptor antagonist, an SGLT2 inhibitor, and diuretics, along with anticoagulation for atrial fibrillation and cardiac resynchronization therapy for specific patients. However, the effectiveness of GDMT in treating AFMR specifically in whom the LVEF is typically preserved (≥50%) is not well-established14, as most prior studies have focused on PMR or heart failure with reduced ejection fraction. From the pathophysiological perspective of AFMR, strategies that restore sinus rhythm from atrial fibrillation have the potential to improve the prognosis of AFMR. Atrial fibrillation cardioversion may reduce the severity of MR, restore atrial size, enhance cardiac diastolic function, and decrease the incidence of endpoint events15-19. Transcatheter edge-to-edge repair (TEER) has emerged as a promising intervention for MR, in all patients with ventricular FMR and in those with PMR who are at high or prohibitive surgical risk14,20-22. Recent studies have demonstrated the efficacy of TEER in reducing the severity of MR, improving symptoms, and enhancing quality of life in patients with secondary MR23-25. However, its role in AFMR, a subset of secondary MR, is less clear. Given the distinct pathophysiology of AFMR and the lack of consensus on optimal management, there is a pressing need for clinical trials comparing the efficacy of TEER versus GDMT in this patient population. Such trials are crucial for informing clinical practice and guiding treatment decisions in AFMR. This clinical trial aims to compare the efficacy and safety of TEER and GDMT in the management of AFMR, filling a significant knowledge gap in current research and potentially influencing future guidelines and patient care strategies.

Conditions

• Atrial Functional Mitral Regurgitation

Interventions

Type	Name	Description
DEVICE	Transcatheter Edge-to-Edge Repair	The intervention to be implemented in this clinical study is Transcatheter Edge-to-Edge Repair (TEER), a minimally invasive, image-guided interventional procedure specifically designed for the treatment of mitral regurgitation (MR)

Timeline

• Start date: 2026-02-25
• Primary completion: 2030-02-25
• Completion: 2030-02-25
• First posted: 2026-02-17
• Last updated: 2026-02-17

Locations

1 site across 1 country: China