Safety and Efficacy of Novel Morphology Classification-Guided Mitral Valve Transcatheter Edge-to-Edge Repair for Patients With Commissural Degenerative Mitral Regurgitation: Design and Rationale of the TEER-CD Trial
Year: 2025
Type: article
Study design: Study Protocol
Abstract: Background: Mitral commissural prolapse or flail, characterized by intricate and diverse anatomical features, poses a significant challenge in mitral transcatheter edge-to-edge repair (M-TEER). Previous studies have largely focused on central mitral regurgitation with favorable valve anatomy or a general broad spectrum of complex mitral regurgitation. However, no established approach is currently available for M-TEER in commissural degenerative mitral regurgitation (DMR). Methods: Therefore, this study aimed to evaluate the efficacy and safety of a novel morphology classification-guided M-TEER strategy for treating commissural DMR using the MitraClip system. This prospective, multicenter, single-arm, objective performance criteria study involved 12 experienced centers in Asia, primarily located in China. Patients with symptomatic moderate-to-severe (3+) and severe (4+) native DMR and commissural involvement were stratified into three morphological categories based on an echocardiographic core laboratory analysis, and tailored M-TEER strategies were proposed. The primary endpoint is the proportion of patients achieving a mitral regurgitation (MR) grade of ≤1+ without repeat mitral intervention at one-year follow-up. Clinical, echocardiographic, functional, and quality-of-life outcomes were assessed over one year. Results: Based on statistical power calculations, a total of 148 patients are required to achieve adequate power to test the primary efficacy hypothesis, accounting for an estimated 10% attrition rate at 12 months. Conclusions: The morphology classification system enhances M-TEER for commissural DMR by addressing the unique challenges of this approach, enabling tailored interventions that optimize procedural success and patient outcomes. Clinical Trial Registration: ChiCTR2400090258, https://www.chictr.org.cn/showproj.html?proj=239191.
DOI: 10.31083/rcm39373
Institutions: Capital Medical University, Beijing Anzhen Hospital, Second Affiliated Hospital of Zhejiang University, Zhejiang University, Taipei Veterans General Hospital, Nanjing First Hospital, Harbin Medical University, Second Affiliated Hospital of Harbin Medical University, First Affiliated Hospital of Xi'an Jiaotong University, Sir Run Run Shaw Hospital, Xiamen University, Sun Yat-sen University, Sun Yat-sen Memorial Hospital, First Affiliated Hospital of Nanchang University, The First Affiliated Hospital, Sun Yat-sen University, People's Hospital of Xinjiang Uygur Autonomous Region, Los Robles Hospital & Medical Center, Chinese University of Hong Kong
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,200
OpenAlex ID: W7117733168