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.

backgroundThe standard transcatheter edge-to-edge repair (TEER) procedure is commonly performed under the coguidance of both transesophageal echocardiography (TEE) and fluoroscopy. Our group has successfully simplified the procedural methodology by performing the TEER procedure under sole TEE guidance. The Echo-CLIP study is designed to evaluate the efficacy, safety, and economic cost of the novel guidance strategy compared with the conventional one.

methodsThe ECHO-CLIP study contains an open-label, prospective, multicenter, noninferiority, randomized clinical trial aiming to compare the outcomes of TEER procedure under the sole TEE guidance with coguidance of TEE and fluoroscopy in treating patients with mitral regurgitation ≥3+. A total of 200 patients will be enrolled and randomized in a 1:1 ratio to the 2 groups. The primary outcome is the success rates at 30 days after device implantation. The secondary outcomes include multiple indicators in terms of survival, adverse events, quality of life, physical functional capacity, hemodynamics, and economic costs at 30 days, 3 months, and 1 year. The ECHO-CLIP study also contains an additional single-arm cohort to evaluate outcomes of solely TEE-guided TEER in those patients contraindicated to radiation.

conclusionThe ECHO-CLIP study will determine whether the outcomes of TEER under sole TEE guidance are noninferior to those under conventional coguidance of TEE and fluoroscopy. The study will offer supportive clinical evidence of this novel procedural methodology and extend TEER application. REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT06684171.