Mitral regurgitation,Atrial fibrillation
Conditions
Interventions
Experimental group:Acceptance of the combined M-TEER (M-TEER devices marketed in China) and LAAC (WATCHMAN FLX) "one-stop" procedure. Postoperative medication regimen: Oral anticoagulant therapy (dire
Control group:Acceptance of the M-TEER procedure only (using M-TEER devices marketed in China). Postoperative medication regimen: Lifelong oral anticoagulant therapy (direct oral anticoagulant DOAC or
Sponsors
Beijing Anzhen Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects aged >=18 years; 2. Subjects with moderate to severe or more severe secondary mitral regurgitation (also known as functional mitral regurgitation), who remain symptomatic despite guideline-directed medical therapy (GDMT, including cardiac resynchronization therapy [CRT] if necessary), and who meet the indications for transcatheter edge-to-edge repair (TEER); 3. Subjects with left atrial enlargement, defined as a maximum anteroposterior left atrial diameter >45 mm, or left atrial area >24 cm^2, or left atrial area index >15 cm^2/m^2 as shown on transthoracic echocardiography (TTE); 4. Subjects diagnosed with paroxysmal, persistent, or permanent atrial fibrillation, and who meet the requirements of the WATCHMAN FLX instructions for use; 5. Subjects who meet the indications for left atrial appendage closure (LAAC), including a CHA2DS2-VASc score >=2 and HAS-BLED score >=3, or those who are unable or unwilling to take long-term oral anticoagulation therapy; 6. Subjects suitable for the defined post-implant anticoagulation and antiplatelet therapy regimen after WATCHMAN FLX device implantation; 7. If the left atrial appendage is occluded (i.e., the subject has no other conditions requiring long-term anticoagulation therapy according to current standard medical practice), the subject is eligible to discontinue anticoagulant therapy; 8. Subjects capable of understanding and willing to sign a written informed consent form to participate in the trial; 9. Subjects able and willing to return as required for follow-up and examinations.
Exclusion criteria
Exclusion criteria: 1. Mitral valve area =50% accompanied by ipsilateral transient or visual TIA, presenting as transient blackouts, ipsilateral hemispheric TIA, or ipsilateral stroke within 6 months); 7. History of left atrial appendage closure; 8. Mitral valve anatomy unsuitable for TEER; 9. The patient is participating in another clinical trial involving a cardiovascular device or investigational drug (participation in post-marketing studies and registry studies is acceptable); 10. The patient is pregnant or plans to become pregnant during the study (if of childbearing potential); 11. Any medical condition or laboratory abnormality prior to randomization that the investigator considers clinically significant and likely to interfere with the study, or not meeting the surgical indications for TEER or LAAC; 12. The patient has an expected life expectancy of less than 1 year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of the composite endpoint event, occurring for the first time within 2 years after randomization, including all-cause death, any stroke (ischemic or hemorrhagic), life-threatening bleeding, or major bleeding (BARC types 2, 3, and 5); | — |
Secondary
| Measure | Time frame |
|---|---|
| The individual components of the primary composite endpoint include: all-cause death, any stroke, life-threatening bleeding, or major bleeding events (BARC Types 2, 3, and 5);Acute procedural success;Acute device success;Device-related complications, including mitral stenosis, single leaflet device attachment (SLDA), device-related thrombosis, peri-device leak, and cardiac perforation;Device- or procedure-related events requiring cardiac surgical intervention (sternotomy) or major endovascular intervention (such as pseudoaneurysm repair, arteriovenous fistula repair, or other major endovascular repair procedures);Total costs over the entire study period, including treatment costs during the index hospitalization, medication costs during the follow-up period, and any outpatient or inpatient treatment costs associated with adverse events; | — |
Countries
China
Contacts
Public ContactGuangyuan Song
Beijing Anzhen Hospital, Capital Medical University
Outcome results
None listed