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

NCT06684171 | Recruiting DMC

• 1 other identifier: NO.SP2024005(01)A
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mitral Regurgitation

Keywords

mitral regurgitation; transcatheter edge-to-edge repair; ECHO-CLIP; randomized clinical trail; ultrasound; echo

Outcome Measures

Primary Outcomes (1)

• 30-day successful rate after device implantation (residual MR ≤2+)

  The primary outcome is the success rate of device implantation at 30 days ( residual MR≤moderate). Evaluation of the primary endpoints was done by specialized sonographers blinded to the intervention.

  At 30 days after device implantation

Secondary Outcomes (29)

• 1-year all-cause mortality

  At 1 year after implantation

• 1-year composite of death, reintervention, and recurrent MR ≥ 3+

  At 1 year after implantation

• Change in SF-36 score from baseline to 30 days and 1 year.

  At 30 days and 1 year after implantation

• Change in KCCQ score from baseline to 30 days and 1 year.

  At 30 days and 1 year after implantation

• Change in HADS score from baseline to 30 days and 1 year.

  At 30 days and 1 year after implantation

Study Arms (2)

Echocardiography-guided group

EXPERIMENTAL

Patients randomized to the echocardiography-guided group will undergo TEER procedure under fully echo guidance.

Procedure: Echocardiographic guidance

Fluoroscopy-guided group

ACTIVE COMPARATOR

Patients randomized to the fluoroscopy-guided group will undergo TEER procedure under combined guidance of X ray and echo.

Procedure: Fluoroscopic guidance

Interventions

Echocardiographic guidance PROCEDURE

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

Echocardiography-guided group

Fluoroscopic guidance PROCEDURE

After detailed evaluation, patients randomized in this group will undergo TEER procedure under combined guidance of echocardiography and fluoroscopy in the entire process.

Fluoroscopy-guided group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pan Xiangbin: lead

Study Sites (1)

Fuwai Hospital Chinese Academy of Medical Sciences Shenzhen

Shenzhen, Guangdong, 518000, China

RECRUITING

Related Publications (1)

• 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 27.

  PMID: 40576040 DERIVED

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Xiangbin Pan

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiangbin Pan

CONTACT

8688396666; panxiangbin@fuwaihospital.org

Jianrui Ma

CONTACT

8688396666; Jianrui0705@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The Vice President of Fuwai Hospital, Chinese Academy of Medical Sciences, and Director of the Structural Heart Disease Center.

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 12, 2024
• Study Start: March 29, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)