Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
NCT ID:
NCT06901466
Eligibility Criteria:
Inclusion Criteria:
* Patients who had undergone successful TEER (Defined as techinal success according to MVARC );
* Need for long-term oral anticoagulation;
* Ability to understand the requirements of the trial and willingness to comply with the trial protocol procedures;
* Providing written informed consent form；
* Women of childbearing potential must use an acceptable method of contraception from signing the informed consent form until the date of the last dose of antithrombotic drug;
* The heart team agrees on the antithrombotic strategies.
Exclusion Criteria:
* Severe renal impairment (creatinine clearance rate\<15ml/min or on dialysis)；
* Postoperative persistent bleeding (overt bleeding either associated with a drop in the hemoglobin of 3.0 g/dl or requiring transfusion of 3 U of whole blood or packed red blood cells) or occurrence of vascular complications；
* Platelet count ≤ 30 ×10\^9/L；
* Need for reoperation；
* History of intracranial or intracerebral hemorrhage；
* History of gastrointestinal ulcers or hemorrhage；
* Any hepatic disease associated with coagulopathy (Child-Pugh B or C);
* Allergy, intolerance or contraindication to oral anticoagulation or antiplatelet drug;
* History of cerebrovascular event or transient ischemic attack within the past 6 weeks;
* Current antiplatelet therapy；
* Patients who have participated in another drug or device investigational study within the past 30 days；
* Life expectancy \<12 months；
* Pregnant or breastfeeding women。
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT06901466
Study Brief:
Protocol Section:
NCT06901466