STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-Edge Repair in Patients Without an Indication for Oral Anticoagulant

NCT07007143 · tracked via the Priya Life Science China tracker

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Phase

Phase 4

Started

2025-07-31

Last updated

2026-03-09

Condition(s) studied

Mitral Regurgitation

Investigational drug(s) / intervention(s)

Experimental: Aspirin monotherapyActive Comparator: Aspirin+Clopidogrel

Experimental: Aspirin monotherapy: Aspirin monotherapy

Active Comparator: Aspirin+Clopidogrel: Aspirin+Clopidogrel

Study 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

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

Inclusion Criteria: * 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. Exclusion Criteria: * Severe renal impairment (creatinine clearance \< 15 mL/min or requiring dialysis). * Ongoing postoperative bleeding (defined as overt bleeding with a ≥3.0 g/dL drop in hemoglobin or requiring ≥3 units of blood transfusion), or vascular complications following the index TEER procedure. * Platelet count \< 50 × 10\^9 /L. * Need for reoperation due to complications of the index TEER procedure. * Recent ( \< 12 month) intracranial or intracerebral hemorrhage. * Recent ( \< 12 month) gastrointestinal ulcers or hemorrhage. * Hepatic disease with coagulopathy.(eg, Child-Pugh class B or C cirrhosis). * Allergy, intolerance, or contraindication to research drugs. * Participation in another investigational drug or device study within 30 days. * Indication for long-term OAC. * Absolute indication for dual antiplatelet therapy; (eg, recent PCI). * Life expectancy \< 12 months. * Pregnancy or breastfeeding.

Primary outcome measure(s)

All bleeding complications at 1 year after TEER — 1 year
For the classification of bleeding complications, the Mitral Valve Academic Research Consortium (MVARC) Primary Bleeding Scale is used. All bleeding can be categorized into five types: minor bleeding, major bleeding, extensive bleeding, life-threatening bleeding, and fatal bleeding.

Trial sites (1)

Facility	City	Region	Status
Chinese Academy of Medical Sciences, Fuwai Hospital	Beijing	Beijing Municipality	Recruiting

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Other trials for the same condition

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Structural Heart Surgery Assist System for Transcatheter Mitral Valve Edge-to-Edge Repair (TEER). Recruiting

Safety and Efficacy of the HighLife Transcatherter Mitral Valve Replacement System in Patients With Moderate-severe or Severe Mitral Regurgitation in China Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07007143 on ClinicalTrials.gov ↗ ← All trials in China