RCT of Minimalist vs Standard Procedure for LAAC in NVAF Patients

Launched by SHANGHAI ZHONGSHAN HOSPITAL · May 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different procedures for closing a small pouch in the heart called the left atrial appendage (LAAC) in patients with a type of irregular heartbeat known as non-valvular atrial fibrillation (NVAF). The standard procedure for this is done under general anesthesia and requires special imaging, while the new "minimalist" approach uses local anesthesia and different imaging techniques. This trial aims to compare how effective and safe both procedures are, helping doctors understand which might be better for patients.

To be eligible for the trial, participants must be between 18 and 85 years old, understand the purpose of the study, and be willing to sign a consent form. They should have a specific score indicating a higher risk for stroke and may not be suitable for long-term blood thinners. However, people with certain health conditions, like severe heart or kidney problems, or those who have a high risk of bleeding, won't be able to participate. If someone joins the trial, they can expect regular follow-ups to monitor their health after the procedure.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18 - 85 years old, all genders;
• • 2. Subjects who can understand the purpose of the trial, participate voluntarily and sign the informed consent form, and are willing to complete the follow-up according to the protocol requirements;
• • 3. Indications for left atrial appendage closure: non-valvular atrial fibrillation patients with CHA2DS2-VAS2 score ≥2 and HAS-BLED score ≥3, or who are unable or unwilling to receive long-term oral anticoagulants;
• • 4. Life expectancy ≥1 year;
• Exclusion Criteria:
• • 1. Preoperative TEE/heart CT/intracardiac ultrasound suggested thrombus in the left atrial appendage/left atrium;
• • 2. Patients with severe renal insufficiency (creatinine ≥200 μmol/L, creatinine clearance \<30 ml/min);
• • 3. Liver disease patients with coagulation abnormalities and clinically relevant bleeding risks, including liver cirrhosis patients reaching Child Pugh stages B and C;
• • 4. Severely decreased platelet count at baseline: PLT ≤50\*10\^9/L;
• • 5. Patients with severe preoperative cardiac insufficiency (LVEF \<35%; clinical manifestations are uncontrolled class IV heart failure);
• • 6. Combined with other severe cardiac valvular diseases or other structural abnormalities that require surgical treatment on an elective day; or severe coronary heart disease that requires intervention within a fixed period;
• • 7. Patients who have lesions or conditions with a significant risk of major bleeding, such as current or recent gastrointestinal ulcers, malignant tumors with a high risk of bleeding, recent brain or spinal injuries, recent brain, spinal or ophthalmic procedure, recent intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms, or major intraspinal or intracerebral vascular malformations;
• • 8. Patients with concurrent diseases (other than atrial fibrillation) that require anticoagulant therapy (such as after mechanical valve replacement, and spontaneous or recurrent venous thromboembolism);
• • 9. Patients who are in clinical trials of other drugs or medical devices and have not completed it yet;
• • 10. Patients who are considered ineligible to participate in the clinical trial by the investigator.