Comparison of Transcatheter Edge-to-edge Repair Using Echo Only with Echo Combined with X Ray for Mitral Regurgitation (ECHO-CLIP)

Официальное название

A Randomized Clinical Trial of Transcatheter Edge-to-edge Repair for Mitral Regurgitation Under Fully Echocardiographic Guidance Compared with Under Combined Guidance of Both Echocardiography and Fluoroscopy (ECHO-CLIP Study)

Обзор

Mitral regurgitation (MR) is a common valvular heart disease in the elderly population, frequently associated with poor prognosis if not treated. Transcatheter edge-to-edge repair (TEER) has recently emerged as a popular strategy due to minimal invasiveness. What's more, previous studies, such as EVEREST II and COAPT study, have demonstrated its efficacy in high-risk patients with primary or secondary MR. Conventional TEER procedure, however, is performed under combined guidance of both echocardiography and fluoroscopy, which potentially results in high radiation exposure and limits its application. Since 2021 2021, the investigators have changed the procedural methodology by performing TEER under full echocardiographic guidance on accumulated dozens of MR patients successfully. To confirm the efficacy of a fully echo-guided TEER procedure, the investigators conduct the ECHO-CLIP study to compare its outcomes with the conventional TEER procedure, as well as evaluate the outcomes of this novel methodology in special populations with radiation contraindications. ECHO-CLIP study is a prospective, multicenter, open-label, noninferior, randomized controlled trial of TEER by two different methodological strategies in treating severe primary or secondary MR. It is anticipated to enroll a total of 200 patients as well to complete the enrollment before Dec 31, 2025 and the follow-up before Dec 31, 2026. This work will potentially demonstrate the feasibility and efficacy of the fully echo-guided TEER procedure, thereby revolutionizing the TEER methodology and benefiting more patients.

Вмешательства

• Процедура Echocardiographic guidance
  After detailed evaluation, patients randomized in this group will undergo TEER procedure under guidance of fully echocardiography but any fluoroscopy in the entire process.
• Процедура Fluoroscopic guidance
  After detailed evaluation, patients randomized in this group will undergo TEER procedure under combined guidance of echocardiography and fluoroscopy in the entire process.

Первичные конечные точки

• 30-day successful rate after device implantation (residual MR ≤2+) [Срок оценки: At 30 days after device implantation]

Вторичные конечные точки (12)

• 1-year all-cause mortality [Срок оценки: At 1 year after implantation]
• 1-year composite of death, reintervention, and recurrent MR ≥ 3+ [Срок оценки: At 1 year after implantation]
• Change in SF-36 score from baseline to 30 days and 1 year. [Срок оценки: At 30 days and 1 year after implantation]
• Change in KCCQ score from baseline to 30 days and 1 year. [Срок оценки: At 30 days and 1 year after implantation]
• Change in HADS score from baseline to 30 days and 1 year. [Срок оценки: At 30 days and 1 year after implantation]
• Composite of major adverse events [Срок оценки: Immediately after implantation, at 30 days, 3 months, and at 1 year]
• Left ventricular ejection fraction [Срок оценки: At 30 days, 3 months, and 1 year after implantation]
• Left ventricular end-diastolic volume and left ventricular end-systolic volume [Срок оценки: At 30 days, 3 months, and 1 year after implantation.]
• Left ventricular end-systolic diameter and left ventricular end-diastolic diameter [Срок оценки: At 30 days, 3 months, and 1 year after implantation]
• NYHA functional classification [Срок оценки: At 30 days, 3 months, and 1 year after implantation.]
• Regurgitant volume and regurgitant fraction [Срок оценки: At 30 days, 3 months, and 1 year after implantation]
• Device implantation rate [Срок оценки: At 30 days after device implantation]

Критерии участия

Критерии включения

\*Subjects meet either the first or second inclusion criteria in combination with the third and fourth ones were eligible.

• Symptomatic DMR subjects with MR ≥ 3+ at high surgical risk in terms of STS Predicted Risk of Mortality replacement score ≥ 8 or STS Predicted Risk of Mortality repair score ≥ 6.\*
• FMR subjects with LVESD ≤ 70 mm and MR ≥ 3+, despite administration of GDMT for 30 days.\*
• MV anatomy appropriate for TEER procedure.
• Subjects willing to participate in this study and complete the follow-up on schedule after obtaining informed consent.

Критерии исключения

• Myocardial infarction within 12 weeks prior to randomization.
• Need for concurrent other cardiac procedures.
• Any endovascular intervention or surgery within 30 days prior to randomization.
• LVEF < 20%.
• MV orifice area < 4.0 cm2.
• Pulmonary artery systolic pressure > 70 mmHg, as determined by echocardiogram.
• Severe mitral annular calcification.
• Unsuitable MV anatomy potentially precluding clip implantation: leaflet calcification or significant leaflet cleft in the grasping zone.
• Previous MV surgery or current implanted ventricular assist device or current implanted mechanical prosthetic valve.
• Any intracardiac mass, thrombus, or vegetation, as evidenced by echocardiogram.
• Active endocarditis or rheumatic heart disease.
• History of DVT or PE.

Abbreviations: DMR, degenerative mitral regurgitation; MR, mitral regurgitation; STS, Society of Thoracic Surgeons; FMR, functional mitral regurgitation; LVESD, left ventricular end-systolic diameter; GDMT, guideline-directed medical therapy; TEER, transcatheter edge-to-edge repair; LVEF, left ventricular ejection fraction; MV, mitral valve; DVT, deep venous thrombosis; PE, pulmonary embolism.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fuwai Hospital Chinese Academy of Medical Sciences Shenzhen — Шэньчжэнь

Публикации

• Ma J, Wang C, Wang S, Fang F, Zhang F, Yan X, Tang Y, Ouyang W, Pan X, Wang C. Design and Rationale of ECHO-CLIP Study: Transcatheter Edge-to-Edge Repair for Mitral Regurgitation Under Solely Transesophageal Echocardiographic Guidance Compared With Fluoroscopic and Transesophageal Echocardiographic Coguidance. J Am Heart Assoc. 2025 Jul;14(13):e040672. doi: 10.1161/JAHA.124.040672. Epub 2025 Jun 2 PMID 40576040

Идентификаторы

NCT: NCT06684171 · NO.SP2024005(01)A

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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