Actively Recruiting
STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-Edge Repair in Patients With an Indication for Oral Anticoagulant
Led by Chinese Academy of Medical Sciences, Fuwai Hospital · Updated on 2026-03-09
880
Participants Needed
1
Research Sites
176 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.Studies have shown that patients with severe mitral regurgitation exhibit a high prevalence of atrial fibrillation (AF), reaching up to 63%, which is an indication for long-term oral anticoagulation (OAC) therapy. However, no dedicated study has prospectively evaluated different antithrombotic strategies following TEER in patients with an indication for OAC. 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 who have an indication for OAC.
CONDITIONS
Official Title
STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-Edge Repair in Patients With an Indication for Oral Anticoagulant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Successful TEER procedure, defined as technical success per MVARC criteria.
- Indication for long-term oral anticoagulation.
- Ability and willingness to comply with the trial protocol.
- Provision of written informed consent.
- Women of childbearing potential must use effective contraception from consent until final antithrombotic dose.
- Antithrombotic strategy approved by the investigator.
You will not qualify if you...
- Severe renal impairment (creatinine clearance < 15 mL/min or requiring dialysis).
- Ongoing postoperative bleeding or vascular complications after TEER.
- Platelet count less than 50 × 10^9 /L.
- Need for reoperation due to TEER complications.
- Recent (less than 12 months) intracranial or intracerebral hemorrhage.
- Recent (less than 12 months) gastrointestinal ulcers or hemorrhage.
- Liver disease with coagulopathy (e.g., Child-Pugh B or C cirrhosis).
- Allergy, intolerance, or contraindication to study drugs.
- Participation in another investigational drug or device study within 30 days.
- History of stroke or transient ischemic attack within the past 6 weeks.
- Absolute indication for combined anticoagulation and antiplatelet therapy (e.g., recent PCI).
- Life expectancy less than 12 months.
- Pregnancy or breastfeeding.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Chinese Academy of Medical Sciences, Fuwai Hospital
Beijing, Beijing Municipality, China, 100037
Actively Recruiting
Research Team
X
Xiangbin Pan, MD,PhD
CONTACT
Z
Zizheng Liu, M.B
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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