Mitral Valve Regurgitation Clinical Trials

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STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-edge Repair in Patients Without an Indication for Oral Anticoagulant: a Multicenter Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Mitral regurgitation (MR) is the most common valvular heart disease, affecting approximately 24.2 million people worldwide (with a higher prevalence in older age groups). Transcatheter edge-to-edge repair (TEER) is now a well-established strategy in high-risk patients with MR. Globally, over 250,000 patients have benefited from the TEER technique. However, no dedicated study has prospectively evaluated different antithrombotic strategies following TEER in patients undergone TEER procedure. Current guidelines do not provide any recommendations for the antithrombotic management of TEER. Consequently, considerable treatment variation exists in clinical studies and practice. The investigators will conduct a multicenter, open-label randomized trial to compare different antithrombotic strategies following TEER in patients without an indication for OAC.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Successful TEER procedure, defined as technical success per MVARC criteria.

• Ability and willingness to comply with the trial protocol.

• Provision of written informed consent.

• Women of childbearing potential must use effective contraception from the time of consent until the final dose of antithrombotic therapy.

• Antithrombotic strategy approved by the investigator.

Locations
Other Locations
China
Chinese Academy of Medical Sciences, Fuwai Hospital
RECRUITING
Beijing
Contact Information
Primary
Xiangbin Pan, MD,PhD
panxiangbin@fuwaihospital.org
+86(10)88396666
Backup
Zizheng Liu, M.B
liuzizheng00@126.com
+86(10)88396666
Time Frame
Start Date: 2025-07-31
Estimated Completion Date: 2029-09-30
Participants
Target number of participants: 1032
Treatments
Experimental: Aspirin monotherapy
Participants will receive Aspirin monotherapy (100 mg once daily, minimum 12 months).
Active_comparator: Aspirin + Clopicogrel
Participants will receive Aspirin (100 mg once daily, minimum 12 months) plus clopidogrel (75 mg once daily for 3 months).
Related Therapeutic Areas
Sponsors
Leads: Chinese Academy of Medical Sciences, Fuwai Hospital

This content was sourced from clinicaltrials.gov